NCT07311226

A First-in-human, Single-ascending-dose Study of IBI3033 in Healthy Participants

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of IBI3033 in Healthy Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Placebo	Participants in placebo group will receive placebo SC/IV.
DRUG	IBI3033	Participants in IBI3033 group will receive a signle dose of IBI3033 at the protocol specified dose SC/IV.

Timeline

• Start date: 2025-12-23
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: China