NCT06193434

A First In Human (FIH) Study of IBI356 in Healthy Participants and in Atopic Dermatitis Patients

A Phase 1 FIH, Randomized, Double Blind, Placebo Controlled, SAD/MAD Study to Assess Safety, Tolerability and PK in Healthy Participants and in Atopic Dermatitis Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of IBI356 in Healthy Participants and in Atopic Dermatitis Patients

Conditions

• Healthy Participants
• Atopic Dermatitis Patients

Interventions

Type	Name	Description
DRUG	IBI356 for MAD	Receive IBI356 in a multiple dose.
DRUG	Dupilumab for MAD	Active comparator
DRUG	IBI356 for SAD	Receive IBI356 in a single dose.
DRUG	Placebo for SAD	Receive placebo in a single dose.
DRUG	Placebo for MAD	Receive placebo in a multiple dose.

Timeline

• Start date: 2024-01-05
• Primary completion: 2025-08-20
• Completion: 2025-08-20
• First posted: 2024-01-05
• Last updated: 2025-09-02

Locations

1 site across 1 country: China