A Mutiple-dose Study of IBI3033 in Healthy Participants

Phase 1Active Not RecruitingNCT07456839

Innovent Biologics (Suzhou) Co. Ltd.8 enrolled

Overview

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple 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, 8-week treatment period and 8-week follow-up period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Participants

Interventions

PlaceboDRUG

Participants in placebo group will receive placebo SC.

IBI3033DRUG

Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China