This study with ALTB-268 will determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of intravenously administrated ALTB-268 in healthy participants.
This is a Phase I, randomized, double-blind, single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of intravenously administered ALTB-268 in healthy participants. Approximately 24 healthy participants will be recruited. The primary objective is to evalute the safety and tolerability of intravenous infusion of SAD in healthy participants. The secondary objectives are (1) to characterize the PK profile of ALTB-268 in plasma following single IV doses in healthy participants, and (2) to assess the PD of ALTB-268 following single IV doses in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Syneos Health Clinical Research Services, LLC
Miami, Florida, United States
To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - Adverse Events
\- Numbers of participants with adverse events (AEs): seriousness, severity, relationship to the investigational products, outcome, duration, and management
Time frame: Through study completion, up to day 71 of the study
To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - Infusion Site Assessments
\- Infusion site assessments, the extent of local reaction at the infusion site will be graded using the scores described below; a global severity rating for infusion site reactions will be included in the assessment of AEs. Infusion Site Reaction Score: None: No reaction; Mild: Tenderness with or without associated symptoms; Moderate: Pain; lipodystrophy; edema; phlebitis; Severe: Ulceration or necrosis; severe tissue damage; operative intervention indicated.
Time frame: Through study completion, up to day 71 of the study
To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - C-SSRS
\- Columbia suicidality severity rating scale (C-SSRS) is a suicidal ideation and behavior rating scale to evaluate suicide risk.
Time frame: Through study completion, up to day 71 of the study
To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - PHQ-8
\- Patient Health Questionnaire-8 (PHQ-8) depression scale is used for depression screening and severity.
Time frame: Through study completion, up to day 71 of the study
To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - Clinical Laboratory Test
\- Clinical laboratory test results, including white blood cell, lymphocyte and neutrophail (cell counts/ul).
Time frame: Through study completion, up to day 71 of the study
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Pharmacokinetic (PK) of ALTB-268 AUC
* AUC0-t, area under the concentration-time curve from time 0 to t hours * AUC0-inf, area under the concentration-time curve from time 0 to infinity
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Cmax
Mmaximum concentration (Cmax)
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Tmax
Time to reach Cmax (Tmax)
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 T½
Terminal half-life (T½)
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 CL
Total body clearance (CL)
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Vz
Volume of distribution (Vz)
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Vss
Steady-state volume of distribution (Vss)
Time frame: Through study completion, up to day 71 of the study
Pharmacodynamics (PD) of ALTB-268 following single IV doses in healthy participants.
Levels of free soluble P-selectin glycoprotein ligand-1 (sPSGL-1) in plasma.
Time frame: Through study completion, up to day 71 of the study
Immunogenicity of ALTB-268 in plasma following single IV doses in healthy participants
Incidence and level of anti-drug antibodies (ADAs).
Time frame: Through study completion, up to day 71 of the study