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A First-in-human, Single-ascending-dose Study of IBI3033 in Healthy Participants
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3033 in Chinese healthy participants. The entire trial cycle includes a 4-week screening period, 1-day treatment period and 12-week follow-up period.
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of IBI3033 in Healthy Participants
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-12-23
Completion Date
2026-06-30
Last Updated
2025-12-30
Healthy Volunteers
Yes
Conditions
Interventions
Placebo
Participants in placebo group will receive placebo SC/IV.
IBI3033
Participants in IBI3033 group will receive a signle dose of IBI3033 at the protocol specified dose SC/IV.
Locations (1)
Shanghai General Hospital
Shanghai, Shanghai Municipality, China