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

NCT06193434 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2025-09-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-05
Primary Completion
2025-08-20
Completion
2025-08-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06193434 on ClinicalTrials.gov