This is a Phase I, open-label, two-cohort study designed to evaluate the drug-drug interaction potential of multiple-dose UBT251 Injection in adult participants with overweight or obesity. The primary objective of Cohort 1 is to evaluate the effect of UBT251 Injection on the pharmacokinetic (PK) profiles of metformin and warfarin. The secondary objectives of Cohort 1 are to assess the influence of UBT251 Injection on the pharmacodynamic (PD) characteristics of warfarin, to evaluate the safety of UBT251 Injection administered alone, as well as metformin and warfarin administered alone or in combination with UBT251 Injection, and to characterize the PK, PD, and immunogenicity profiles following repeated UBT251 Injection dosing. The primary objective of Cohort 2 is to evaluate the effect of UBT251 Injection on the PK profiles of atorvastatin and digoxin. The secondary objectives of Cohort 2 are to evaluate the safety of UBT251 Injection alone, atorvastatin and digoxin alone, and their combination with UBT251 Injection, as well as to assess the PK, PD, and immunogenicity characteristics after multiple administrations of UBT251 Injection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
48
Subcutaneous injection administered once weekly with dose escalation
Oral administration. Metformin hydrochloride will be given as twice-daily doses for 7 consecutive administrations.
Oral administration. Warfarin sodium will be given as 2 single doses.
Oral administration. Atorvastatin calcium will be given as 2 single doses.
Oral administration. Digoxin will be given as 2 single doses.
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGArea under plasma concentration-time curve of metformin (AUC0-τ) and S-warfarin, R-warfarin (AUC0-t, AUC0-∞)
Compare AUC0-τ of metformin after multiple-dose administration alone, and AUC0-t and AUC0-∞ of S-warfarin and R-warfarin after single-dose administration alone, with the corresponding parameters when these drugs are administered following dose-escalated and continued 6.0 mg UBT251 in Cohort 1.
Time frame: From time 0 to 30 hours (metformin, post last dose) and 168 hours (S-warfarin, R-warfarin) after respective doses
Area under plasma concentration-time curve (AUC0-t and AUC0-∞) of atorvastatin and digoxin
Compare AUC0-t and AUC0-∞ of single-dose atorvastatin and single-dose digoxin administered alone, with corresponding parameters when administered following dose-escalated and continued 6.0 mg UBT251 in Cohort 2.
Time frame: From time 0 to 72 hours (atorvastatin) and 120 hours (digoxin) after respective single doses
Peak Plasma Concentration (Cmax) of metformin in Cohort 1
Peak plasma concentration (Cmax) of metformin at steady-state in Cohort 1
Time frame: Up to 30 hours following last dose at steady-state
Time to Peak Plasma Concentration (Tmax) of metformin in Cohort 1
Time to reach peak plasma concentration (Tmax) of metformin at steady-state in Cohort 1
Time frame: Up to 30 hours following last dose at steady-state
Area under the plasma concentration-time curve from 0 to last measurable time point (AUC0-t) of metformin in Cohort 1
Area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUC0-t) of metformin at steady-state in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) of metformin in Cohort 1
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞) of metformin at steady-state in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Apparent volume of distribution (Vz/F) of metformin in Cohort 1
Apparent volume of distribution (Vz/F) of metformin at steady-state in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Apparent total clearance (CL/F) of metformin in Cohort 1
Apparent total clearance (CL/F) of metformin at steady-state in Cohort 1
Time frame: Up to 30 hours following last dose at steady-state
Terminal elimination rate constant (λz) of metformin in Cohort 1
Terminal elimination rate constant (λz) of metformin at steady-state in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Terminal half-life (t1/2z) of metformin in Cohort 1
Terminal elimination half-life (t1/2z) of metformin at steady-state in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Peak Plasma Concentration (Cmax) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates maximum plasma concentration (Cmax).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Time to Maximum Plasma Concentration (Tmax) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates time to maximum plasma concentration (Tmax).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Rate Constant (λz) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal rate constant (λz).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Half-Life (t1/2z) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal half-life (t1/2z).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Clearance (CL/F) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent clearance (CL/F).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Volume of Distribution (Vz/F) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent volume of distribution (Vz/F).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Maximum Plasma Concentration (Cmax) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates maximum plasma concentration (Cmax).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Time to Maximum Plasma Concentration (Tmax) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates time to maximum plasma concentration (Tmax).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Rate Constant (λz) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal rate constant (λz).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Half-Life (t1/2z) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal half-life (t1/2z).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Clearance (CL/F) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent clearance (CL/F).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Volume of Distribution (Vz/F) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent volume of distribution (Vz/F).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Maximum Plasma Concentration (Cmax) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state maximum plasma concentration (Cmax).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Time to Maximum Plasma Concentration (Tmax) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state time to maximum plasma concentration (Tmax).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve from zero to last measurable time-point (AUC0-t).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUC0-τ) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve over dosing interval (AUC0-τ).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Terminal Rate Constant (λz) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal rate constant (λz).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Terminal Half-Life (t1/2z) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal half-life (t1/2z).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Apparent Clearance (CL/F) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent clearance (CL/F).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Apparent Volume of Distribution (Vz/F) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent volume of distribution (Vz/F).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Maximum Plasma Concentration (Cmax) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates maximum plasma concentration (Cmax).
Time frame: Pre-dose and up to 72 hours following single dose
Time to Maximum Plasma Concentration (Tmax) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Rate Constant (λz) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal rate constant (λz).
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Half-Life (t1/2z) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).
Time frame: Pre-dose and up to 72 hours following single dose
Apparent Clearance (CL/F) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates apparent clearance (CL/F).
Time frame: Pre-dose and up to 72 hours following single dose
Apparent Volume of Distribution (Vz/F) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates apparent volume of distribution (Vz/F).
Time frame: Pre-dose and up to 72 hours following single dose
Maximum Plasma Concentration (Cmax) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates maximum plasma concentration (Cmax).
Time frame: Pre-dose and up to 72 hours following single dose
Time to Maximum Plasma Concentration (Tmax) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).
Time frame: Pre-dose and up to 72 hours following single dose
Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to last measurable time-point (AUC0-t).
Time frame: Pre-dose and up to 72 hours following single dose
Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC0-∞) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to infinity (AUC0-∞).
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Rate Constant (λz) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal rate constant (λz).
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Half-Life (t1/2z) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).
Time frame: Pre-dose and up to 72 hours following single dose
Maximum Plasma Concentration (Cmax) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates maximum plasma concentration (Cmax).
Time frame: Pre-dose and up to 72 hours following single dose
Time to Maximum Plasma Concentration (Tmax) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).
Time frame: Pre-dose and up to 72 hours following single dose
Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to last measurable time-point (AUC0-t).
Time frame: Pre-dose and up to 72 hours following single dose
Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC0-∞) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to infinity (AUC0-∞).
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Rate Constant (λz) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal rate constant (λz).
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Half-Life (t1/2z) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).
Time frame: Pre-dose and up to 72 hours following single dose
Time to Maximum Plasma Concentration (Tmax) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).
Time frame: Pre-dose and up to 120 hours following single dose
Terminal Rate Constant (λz) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates terminal rate constant (λz).
Time frame: Pre-dose and up to 120 hours following single dose
Terminal Half-Life (t1/2z) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).
Time frame: Pre-dose and up to 120 hours following single dose
Apparent Clearance (CL/F) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates apparent clearance (CL/F).
Time frame: Pre-dose and up to 120 hours following single dose
Apparent Volume of Distribution (Vz/F) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates apparent volume of distribution (Vz/F).
Time frame: Pre-dose and up to 120 hours following single dose
Maximum Plasma Concentration (Cmax) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state maximum plasma concentration (Cmax).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Time to Maximum Plasma Concentration (Tmax) of UBT251 in Cohort 2
Time to Maximum Plasma Concentration (Tmax) of UBT251 in Cohort 2
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve from zero to last measurable time-point (AUC0-t).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUC0-τ) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve over dosing interval (AUC0-τ).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Terminal Rate Constant (λz) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal rate constant (λz).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Terminal Half-Life (t1/2z) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal half-life (t1/2z).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Apparent Clearance (CL/F) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent clearance (CL/F).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Apparent Volume of Distribution (Vz/F) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent volume of distribution (Vz/F).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the INR-Time Curve (AUCINR) of Warfarin Under UBT251 Steady-State in Cohort 2
Serial INR measurements are collected to characterize the pharmacodynamic effect of warfarin, when administered under UBT251 steady-state conditions. This endpoint evaluates area under the INR-time curve (AUCINR).
Time frame: Baseline to 168 hours
Maximum Observed INR (INRmax) of Warfarin Under UBT251 Steady-State in Cohort 2
Serial INR measurements are collected to characterize the pharmacodynamic effect of warfarin administered under UBT251 steady-state conditions. This endpoint evaluates maximum observed INR (INRmax).
Time frame: Baseline to 168 hours
Change in Body Weight From Pre-treatment Baseline Following UBT251 Dosing in Cohort 2
Body weight is measured at baseline and scheduled visits. This endpoint evaluates body weight change relative to pre-UBT251 baseline.
Time frame: throughout UBT251 titration period
Incidence, Maximum Severity Grade, and Duration of Adverse Events and Serious Adverse Events During UBT251 Treatment
All adverse events and serious adverse events are actively monitored and recorded throughout the study. This outcome assesses the incidence defined as percentage of affected subjects, maximum severity grade classified according to CTCAE criteria, and duration in days of each adverse event.
Time frame: Baseline up to Study Day 190
Changes From Baseline in Vital Signs During UBT251 Treatment
Vital signs including systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature are measured using standard clinical equipment at scheduled visits. This outcome evaluates absolute and relative changes from baseline throughout the study period.
Time frame: Baseline up to Study Day 190
Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters During UBT251 Treatment
12-lead ECGs are collected at scheduled visits and can be additionally performed at any time for safety monitoring. Participants rest in a supine position for at least 5 minutes before testing. Assessed parameters include RR interval, PR interval, heart rate, QRS interval, QT interval, QTc interval, and QTcF calculated by Fredericia's formula. This outcome evaluates parameter changes from baseline and clinically significant abnormal ECG findings.
Time frame: Baseline up to Study Day 190
Clinically Significant Abnormal Findings on Complete Physical Examination During UBT251 Treatment
Complete physical examinations are performed at scheduled study visits, covering general condition, skin and mucous membranes, lymph nodes, head and neck, chest, abdomen, spine, and extremities. This outcome summarizes all clinically significant abnormal physical examination findings compared with baseline throughout the study period.
Time frame: Baseline up to Study Day 190
Changes From Baseline in Safety Laboratory Parameters During UBT251 Treatment
Safety laboratory tests include hematology, urinalysis, serum biochemistry, electrolytes, blood glucose, blood lipids, cardiac enzymes, lipase, amylase, coagulation function, glycated hemoglobin, procalcitonin, thyroid function tests, and infectious disease screening. This outcome evaluates changes from baseline and clinically significant laboratory abnormalities.
Time frame: Baseline up to Study Day 190
Incidence of Positive Anti-UBT251 Binding Antibodies in Subjects Receiving UBT251
Validated immunoassay is used as the measurement tool to detect anti-UBT251 binding antibodies. This outcome assesses incidence (percentage of subjects with positive binding antibodies) at scheduled sampling time-points including Study Day 15, 43, 127, 162 and 190.
Time frame: Baseline up to Study Day 190
Antibody Titer Level of Anti-UBT251 Binding Antibodies in Antibody-Positive Subjects
Validated immunoassay is used as the measurement tool to determine antibody titer. This outcome reports titer levels for specimens confirmed positive for anti-UBT251 binding antibodies at scheduled sampling time-points including Study Day 15, 43, 127, 162 and 190.
Time frame: Baseline up to Study Day 190
Incidence of Positive Anti-UBT251 Neutralizing Antibodies (If Applicable) in Subjects Receiving UBT251
Validated cell-based neutralizing antibody assay is used as the measurement tool. This outcome assesses incidence (percentage of subjects with positive neutralizing antibodies), if applicable, at scheduled sampling time-points including Study Day 15, 43, 127, 162 and 190.
Time frame: Baseline up to Study Day 190
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.