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

NCT07311226 | Active Not Recruiting Phase 1

• 1 other identifier: CIBI3033A101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)/serious adverse events (SAEs)

  Percentage of participants who have experienced AEs/SAEs

  Baseline to Day 85

Secondary Outcomes (4)

• PK parameter: Cmax

  Baseline to Day 85

• PK parameter: tmax

  Baseline to Day 85

• PK parameter: AUC

  Baseline to Day 85

• Immunogenticity profiles

  Baseline to Day 85

Study Arms (6)

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

Placebo DRUG

Participants in placebo group will receive placebo SC/IV.

Placebo IV; Placebo SC

IBI3033 DRUG

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

IBI3033 Dose 1 subcutaneously (SC); IBI3033 Dose 2 SC; IBI3033 Dose 2 intravenously (IV); IBI3033 Dose 3 SC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: December 31, 2025
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

CN (1)