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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT06193434
Phase
PHASE1
Status
Completed

Conditions

  • Atopic Dermatitis Patients
  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • IBI356 for MAD — DRUG
    Receive IBI356 in a multiple dose.
  • Dupilumab for MAD — DRUG
    Active comparator
  • IBI356 for SAD — DRUG
    Receive IBI356 in a single dose.
  • Placebo for SAD — DRUG
    Receive placebo in a single dose.
  • Placebo for MAD — DRUG
    Receive placebo in a multiple dose.

Study Details

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

Key Dates

Start date
Jan 5, 2024
Status verified
Aug 2025
Primary completion
Aug 20, 2025
Completion
Aug 20, 2025

Study Design

Enrollment
99 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IBI356 for Single ascending dose (SAD)
  • Experimental: IBI356 for Multiple ascending dose (MAD)
  • Placebo Comparator: Placebo for MAD
  • Active Comparator: Dupilumab for MAD
  • Placebo Comparator: Placebo for SAD

Primary Outcome Measure

Occurrence of Adverse Event (AE) in SAD study. [ Time Frame: Baseline to Week 20 ]

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