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

NCT ID: NCT07311226

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-23

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IBI3033 Dose 1 subcutaneously (SC)

Group Type EXPERIMENTAL

IBI3033

Intervention Type DRUG

Participants in IBI3033 group will receive a signle dose of IBI3033 at the protocol specified dose SC/IV.

Placebo IV

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants in placebo group will receive placebo SC/IV.

IBI3033 Dose 3 SC

Group Type EXPERIMENTAL

IBI3033

Intervention Type DRUG

Participants in IBI3033 group will receive a signle dose of IBI3033 at the protocol specified dose SC/IV.

IBI3033 Dose 2 intravenously (IV)

Group Type EXPERIMENTAL

IBI3033

Intervention Type DRUG

Participants in IBI3033 group will receive a signle dose of IBI3033 at the protocol specified dose SC/IV.

IBI3033 Dose 2 SC

Group Type EXPERIMENTAL

IBI3033

Intervention Type DRUG

Participants in IBI3033 group will receive a signle dose of IBI3033 at the protocol specified dose SC/IV.

Placebo SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants in placebo group will receive placebo SC/IV.

Interventions

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Placebo

Participants in placebo group will receive placebo SC/IV.

Intervention Type DRUG

IBI3033

Participants in IBI3033 group will receive a signle dose of IBI3033 at the protocol specified dose SC/IV.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Wenjing Duan

Role: CONTACT

Phone: +8613810656906

Email: [email protected]

Facility Contacts

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Xueying Ding

Role: primary

Other Identifiers

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CIBI3033A101

Identifier Type: -

Identifier Source: org_study_id