A First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
This is a single center, double-blind, randomized, placebo-controlled, single ascending
subcutaneous dose study in lean to overweight or obese but otherwise healthy men. It is
planned to enroll 4 cohorts of 8 subjects (Regimens A, B, C and D), with 2 additional
optional cohorts of 8 subjects (Regimens E and F). Within each cohort, subjects will be
randomized in a ratio of 6 active to 2 placebo. The primary objective is to assess the
safety. Secondary objectives are to characterize the pharmacokinetics (PK) and to investigate
pharmacodynamic effects.