Placebo: Participants in placebo group will receive placebo SC/IV.
IBI3033: Participants in IBI3033 group will receive a signle dose of IBI3033 at the protocol specified dose SC/IV.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Incidence of adverse events (AEs)/serious adverse events (SAEs) — Baseline to Day 85 Percentage of participants who have experienced AEs/SAEs
Trial sites (1)
Facility
City
Region
Status
Shanghai General Hospital
Shanghai
Shanghai Municipality
More Innovent Biologics (Suzhou) Co. Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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