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

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics 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.

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.