A Mutiple-dose Study of IBI3033 in Healthy Participants

May 21, 2026 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple 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, 8-week treatment period and 8-week follow-up period.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200080
        • Shanghai General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy males/females aged 18-55 years (inclusive).
  2. BMI 18.0-28.0 kg/m²; weight ≥50 kg (male) or ≥45 kg (female).
  3. Willing to use effective contraception for 6 months post-dosing.

Exclusion Criteria:

  1. History of blood or needle sickness, or those who cannot tolerate venipuncture.
  2. Female participants who are pregnant or breastfeeding at screening or randomization.
  3. History of severe infection or significant injury within 6 months, or surgery within 3 months, or any infection requiring systemic medication within 1 month prior to screening.
  4. History of live or attenuated vaccination within 1 month prior to screening, or those who plan to be vaccinated during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo SC
Participants in placebo group will receive placebo SC.
Drug: Placebo
Participants in placebo group will receive placebo SC.
Experimental: IBI3033 Dose 2 SC
Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.
Drug: IBI3033
Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.
Experimental: IBI3033 Dose 1 subcutaneously (SC)
Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.
Drug: IBI3033
Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs)/serious adverse events (SAEs)
Time Frame: Baseline to Day 113
Percentage of participants who have experienced AEs/SAEs
Baseline to Day 113

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK parameter: Cmax
Time Frame: Baseline to Day 113
Observed maximum plasma concentration of IBI3033
Baseline to Day 113
PK parameter: tmax
Time Frame: Baseline to Day 113
Time to achieve Cmax of IBI3033
Baseline to Day 113
PK parameter: AUC
Time Frame: Baseline to Day 113
Area under the plasma concentration-time curve of IBI3033
Baseline to Day 113
Immunogenticity profiles
Time Frame: Baseline to Day 113
Frequency of anti-drug antibody (ADA) of IBI3033
Baseline to Day 113

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 13, 2026

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CIBI3033A102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Participants

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe