Healthy Volunteers Clinical Trial
Official title:
A Single-center, Randomized, Double-blind, Sponsor Open, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 After Single and Multiple Subcutaneous Injections in Chinese Healthy Subjects
This is a Phase 1, randomized, double-blind, placebo-controlled trial of SIM0278 in healthy subjects. The study will be conducted in 2 parts. Part 1 is single ascending dose study. Part 2 is multiple ascending dose study.
The study will assess the safety, tolerability, and pharmacokinetics（PK） after a single or multiple administration of SIM0278 or placebo via subcutaneous injection in healthy subjects (male or female) where PK, pharmacodynamics (PD) and biomarkers will be assessed. Approximately 68 subjects (up to 84) will be enrolled in the whole study. The ratio of active drug to placebo in each dose level will be 3:1. In part1, approximately 44 subjects (up to 52) will be enrolled for the single dose escalation. Six dose levels are planned in part 1. In part2, approximately 24 (up to 32) subjects will be enrolled for the multiple dose escalation. Three dose levels are planned in part 2. ;
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