A First-in-human, Single-ascending-dose Study of IBI3033... | NCT07311226

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

NCT07311226

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Status

Active, not recruiting

Last Update Posted

May 22, 2026Actual

Enrollment

32Actual

Phase

Phase 1

Conditions

Healthy Participants

Interventions

Placebo
IBI3033

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2025Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Dec 16, 2025

First Submission Date that Met QC Criteria

Dec 16, 2025

First Posted Date

Dec 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2026

Last Update Posted Date

May 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
IBI3033 Dose 1 subcutaneously (SC)	Experimental	Drug: IBI3033
Placebo IV	Placebo Comparator	Drug: Placebo
IBI3033 Dose 3 SC	Experimental	Drug: IBI3033
IBI3033 Dose 2 intravenously (IV)	Experimental	Drug: IBI3033
IBI3033 Dose 2 SC	Experimental	Drug: IBI3033
Placebo SC	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Participants in placebo group will receive placebo SC/IV.	Placebo IV Placebo SC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events (AEs)/serious adverse events (SAEs)	Percentage of participants who have experienced AEs/SAEs	Baseline to Day 85

Secondary Outcomes

Measure	Description	Time Frame
PK parameter: Cmax	Observed maximum plasma concentration of IBI3033	Baseline to Day 85
PK parameter: tmax	Time to achieve Cmax of IBI3033

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

History of blood or needle sickness, or those who cannot tolerate venipuncture.
Female participants who are pregnant or breastfeeding at screening or randomization.
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.
History of live or attenuated vaccination within 1 month prior to screening, or those who plan to be vaccinated during the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai General Hospital		Shanghai	Shanghai Municipality	200080	China