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

Last updated: March 12, 2025
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Allergies & Asthma

Eczema (Atopic Dermatitis - Pediatric)

Skin Wounds

Treatment

IBI356 for SAD

Placebo for MAD

Placebo for SAD

Clinical Study ID

NCT06193434
CIBI356A101CN
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy participants:

  2. Aged 18 to 45 years,

  3. Weight 50 to 120 kgs,

  4. Good physical and mental health based on medical history, physical examination,clinical laboratory, ECG, and vital signs, as judged by the Investigator.

  5. No child-bearing potential during the trial and within 6 months after SADdoses, and adequate contraceptive measures can be taken.

  6. Atopic dermatitis:

  7. Aged 18 to 75 years,

  8. body mass index (BMI): 18.0 - 32.0 kg/m2,

  9. Atopic Dermatitis (AD) for 1 year or longer at Baseline,

  10. Eczema Area and Severity Index (EASI) of 16 or higher at baseline,

  11. Investigator Global Assessment (IGA) of 3 or 4 at baseline,

  12. AD involvement of 10 percent or more of body surface area at Baseline,

  13. Documented history, within 1 year before Baseline, of either inadequateresponse to topical treatments or inadvisability of topical treatments,

  14. Must have applied a stable dose of topical bland emollient at least twice dailyfor at least 7 consecutive days before Baseline.

Exclusion

Exclusion Criteria:

  1. History of relevant drug allergies.

  2. Has any condition that, in the opinion of the investigator, would make participationnot be in the best interest (for example, compromise the well-being) of theparticipant or that could prevent, limit, or confound the protocol-specifiedassessments

  3. Healthy participants:

  4. History of alcohol abuse or drug addiction within 1 year before screen,

  5. Positive drug and alcohol screen at screening.

  6. Atopic dermatitis:

  7. Having used any of the following treatments within 4 weeks before the baselinevisit, or any condition that, in the opinion of the investigator, was likely torequire Immunosuppressive/ immunomodulating drugs treatment(s) during the first 4 weeks of study treatment:

  8. Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit.

Study Design

Total Participants: 99
Treatment Group(s): 5
Primary Treatment: IBI356 for SAD
Phase: 1
Study Start date:
January 05, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai 200443
    China

    Site Not Available

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