The goals of this clinical study are to characterize and compare the safety, tolerability, blood levels of UPB-101 when given to healthy Japanese and non-Japanese non-East Asian (NJNEA) adults. Eligible participants will be assigned to one of the 4 planned dosing treatment groups. Treatment groups 1, 2 and 3 will consist of Japanese adults who will be administered a single subcutaneous (SC) dose of UPB-101 (at 3 different strengths). Treatment group 4 will consist of NJNEA participants who will receive a single SC dose of UPB-101. All treatment groups will enroll and run in parallel.
This is a randomized, open-label, parallel group, ethno-bridging study comparing the pharmacokinetics and safety of a single dose of UPB-101 in healthy Japanese and NJNEA adults. The study will include 4 planned dosing treatment groups. Treatment groups 1, 2 and 3 will consist of Japanese adults who will be administered a single subcutaneous (SC) dose of UPB-101 (at 3 different strengths). Treatment group 4 will consist of NJNEA participants who will receive a single SC dose of UPB-101. All treatment groups will enroll and run in parallel. Japanese participants will be enrolled and randomized on Day 1 into treatment groups 1, 2 or 3 and NJNEA participants will be assigned to treatment group 4. Eight participants will be enrolled per treatment group, all will receive a single dose of UPB-101. Thus, a total of 32 male and female participants will be enrolled in the study (24 Japanese participants in treatment groups 1-3 and 8 NJNEA participants in treatment group 4).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
UPB-101 Subcutaneous injection
Richmond Pharmacology
London, United Kingdom
Maximum Observed Concentration (Cmax) of UPB-101
Non-compartmental analysis was used for estimation of PK parameters.
Time frame: Baseline through Day 85
Time to Maximum Observed Concentration (Tmax) of UPB-101
Non-compartmental analysis was used for estimation of PK parameters.
Time frame: Baseline through Day 85
AUC From Time Zero up to the Last Quantifiable Concentration of UPB-101 (AUClast)
Non-compartmental analysis was used for estimation of PK parameters. AUC = Area under the concentration-time curve
Time frame: Baseline through Day 85
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events
Safety endpoints included AEs, SAEs, physical examinations, clinical laboratory assessments, vital signs, ECGs including telemetry, withdrawal of participants, and early terminations.
Time frame: Baseline through Day 85
Immunogenicity Assessment of UPB-101 When Administered to Japanese and NJNEA Adults
The immunogenicity endpoints included UPB-101 Anti-Drug Antibodies (ADAs). Outcome data is the number of participants with Low titer ADA positive results (range 60-240) observed at Day 85.
Time frame: Baseline through Day 85
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