drugset / Trial / NCT06947408

A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Healthy and Asthmatic Participants

NCT06947408

Phase 1 Completed 44 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a randomized, double-blind, placebo-controlled multiple dose ascending study in healthy participants and patients with asthma. Healthy participants will be enrolled in Part A and patients with asthma in Part B: 1. Part A: 40 healthy participants will be enrolled across 5 cohorts, including 5 different dose levels. In each cohort, there will be 8 participants randomized at a ratio of 6:2 to receive IBI3002 or matched placebo. The study consists of a screening period, a double-blind treatment period and a safety follow-up period. The study has a total duration of approximately 12 to 14 weeks. 2. Part B: 20 patients with asthma will be enrolled across 2 cohorts. In each cohort, there will be 10 participants randomized at a ratio of 8:2 to receive IBI3002 or matched placebo. The study consists of a screening period, a double-blind treatment period and a safety follow-up period. The study has a total duration of approximately 16 weeks.

Timeline

Start
2025-05-14
Primary completion
2026-05-11
Completion
2026-05-11

Drugs

EvaluationDrugModalityDoseRoute
Subject IBI3002 Unknown Subcutaneous

Indications