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

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

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

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
Drug: Placebo
Participants in placebo group will receive placebo SC/IV.
Placebo Comparator: Placebo IV
Drug: Placebo
Participants in placebo group will receive placebo SC/IV.
Experimental: IBI3033 Dose 1 subcutaneously (SC)
Drug: IBI3033
Participants in IBI3033 group will receive a signle dose of IBI3033 at the protocol specified dose SC/IV.
Experimental: IBI3033 Dose 3 SC
Drug: IBI3033
Participants in IBI3033 group will receive a signle dose of IBI3033 at the protocol specified dose SC/IV.
Experimental: IBI3033 Dose 2 intravenously (IV)
Drug: IBI3033
Participants in IBI3033 group will receive a signle dose of IBI3033 at the protocol specified dose SC/IV.
Experimental: IBI3033 Dose 2 SC
Drug: IBI3033
Participants in IBI3033 group will receive a signle dose of IBI3033 at the protocol specified dose SC/IV.

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 85
Percentage of participants who have experienced AEs/SAEs
Baseline to Day 85

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK parameter: Cmax
Time Frame: Baseline to Day 85
Observed maximum plasma concentration of IBI3033
Baseline to Day 85
PK parameter: tmax
Time Frame: Baseline to Day 85
Time to achieve Cmax of IBI3033
Baseline to Day 85
PK parameter: AUC
Time Frame: Baseline to Day 85
Area under the plasma concentration-time curve of IBI3033
Baseline to Day 85
Immunogenticity profiles
Time Frame: Baseline to Day 85
Frequency of anti-drug antibody (ADA) of IBI3033
Baseline to Day 85

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)

December 31, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 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

  • CIBI3033A101

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 IBI3033

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe