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NCT Number: NCT07311226

A First-in-human, Single-ascending-dose Study 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Participants in placebo group will receive placebo SC/IV.

IBI3033

Drug

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

Primary outcomes

  1. Incidence of adverse events (AEs)/serious adverse events (SAEs)

    Time frame: Baseline to Day 85

    Percentage of participants who have experienced AEs/SAEs

Secondary outcomes

  1. PK parameter: Cmax

    Time frame: Baseline to Day 85

    Observed maximum plasma concentration of IBI3033

  2. PK parameter: tmax

    Time frame: Baseline to Day 85

    Time to achieve Cmax of IBI3033

  3. PK parameter: AUC

    Time frame: Baseline to Day 85

    Area under the plasma concentration-time curve of IBI3033

  4. Immunogenticity profiles

    Time frame: Baseline to Day 85

    Frequency of anti-drug antibody (ADA) of IBI3033

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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