This study with ALTB-268 will determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of ALTB-268 in healthy volunteers.
This is a Phase I, first-in-human, randomized, double-blind, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered ALTB-268 in healthy volunteers. Up to 40 and 24 healthy volunteers will be recruited in single and multiple ascending doses, respectively. The primary objective is to assess the safety and tolerability of subcutaneously (sc) administered ALTB-268 in healthy volunteers. The secondary objective is to assess the plasma pharmacokinetics of sc administered ALTB-268 in healthy volunteers. The exploratory objectives are to assess the pharmacodynamics and evaluate immunogenicity of sc administered ALTB-268 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
ICON Early Development Services
Lenexa, Kansas, United States
Incidence of ALTB-268 Treatment-Emergent Adverse Events
Adverse events (AEs) - severity of the AEs will be graded using the most current version of the Common Terminology Criteria for AE (CTCAE) (V5.0) 5-point scale. The relationship between AEs and the study drug will be indicated as related or not related.
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 AUC (PK) of sc administered ALTB-268 in healthy volunteers.
Including AUC0-t, AUC0-inf, AUC0-tau
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 Cmax
Maximum plasma concentration
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 tmax
Time to reach Cmax
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 t1/2
Half life
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 CL/F
Apparent clearance, calculated as dose/AUC0-inf
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 Rac
The ratio of accumulation of a drug after repeated administration as compared to a single dose, PART B only
Time frame: through study completion, up to day 120 of the study
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