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

NCT07311226 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07311226 on ClinicalTrials.gov