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

NCT06193434 | Completed Phase 1

• 1 other identifier: CIBI356A101CN
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (14)

• Occurrence of Adverse Event (AE) in SAD study.

  Baseline to Week 20

• Occurrence of Adverse Event (AE) in MAD study.

  Baseline to Week 36

• Occurrence of Serious Adverse Event (SAE) in SAD study.

  Baseline to Week 20

• Occurrence of Serious Adverse Event (SAE) in MAD study.

  Baseline to Week 36

• Changes in blood pressure mmHg (as a measure of safety and tolerability) in SAD study.

  Baseline to Week 20

• Changes in blood pressure mmHg (as a measure of safety and tolerability) in MAD study.

  Baseline to Week 36

• Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in SAD study.

  Baseline to Week 20

• Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in MAD study.

  Baseline to Week 36

• Changes in heart rate bpm (as a measure of safety and tolerability) in SAD study.

  Baseline to Week 20

• Changes in heart rate bpm (as a measure of safety and tolerability) in MAD study.

  Baseline to Week 36

• Changes in tympanic temperature °C in SAD study.

  Baseline to Week 20

• Changes in tympanic temperature °C in MAD study.

  Baseline to Week 36

• Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in SAD study.

  Baseline to Week 20

• Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in MAD study.

  Baseline to Week 36

Secondary Outcomes (6)

• Area under the concentration time curve from time 0 to last observation (AUC 0-t).

  Baseline to Week 16

• Maximum observed concentration (Cmax) after infusion.

  Baseline to Week 16

• Systemic clearance after infusion (CL).

  Baseline to Week 16

• Volume of distribution during the terminal phase after infusion(Apparent volume of distribution, V).

  Baseline to Week 16

• Elimination half-life during the terminal phase after infusion(Half-life, t1/2).

  Baseline to Week 16

Study Arms (5)

IBI356 for Single ascending dose (SAD)

EXPERIMENTAL

Drug: IBI356 for SAD

IBI356 for Multiple ascending dose (MAD)

EXPERIMENTAL

Drug: IBI356 for MAD

Placebo for MAD

PLACEBO COMPARATOR

Drug: Placebo for MAD

Dupilumab for MAD

ACTIVE COMPARATOR

Drug: Dupilumab for MAD

Placebo for SAD

PLACEBO COMPARATOR

Drug: Placebo for SAD

Interventions

IBI356 for MAD DRUG

Receive IBI356 in a multiple dose.

IBI356 for Multiple ascending dose (MAD)

Dupilumab for MAD DRUG

Active comparator

Dupilumab for MAD

IBI356 for SAD DRUG

Receive IBI356 in a single dose.

IBI356 for Single ascending dose (SAD)

Placebo for SAD DRUG

Receive placebo in a single dose.

Placebo for SAD

Placebo for MAD DRUG

Receive placebo in a multiple dose.

Placebo for MAD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy participants:
• Aged 18 to 45 years,
• Weight 50 to 120 kgs,
• Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
• No child-bearing potential during the trial and within 6 months after SAD doses, and adequate contraceptive measures can be taken.
• Atopic dermatitis:
• Aged 18 to 75 years,
• body mass index (BMI): 18.0 - 32.0 kg/m2,
• Atopic Dermatitis (AD) for 1 year or longer at Baseline,
• Eczema Area and Severity Index (EASI) of 16 or higher at baseline,
• Investigator Global Assessment (IGA) of 3 or 4 at baseline,
• AD involvement of 10 percent or more of body surface area at Baseline,
• Documented history, within 1 year before Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments,
• Must have applied a stable dose of topical bland emollient at least twice daily for at least 7 consecutive days before Baseline.

You may not qualify if:

• History of relevant drug allergies.
• Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
• Healthy participants:
• History of alcohol abuse or drug addiction within 1 year before screen,
• Positive drug and alcohol screen at screening.
• Atopic dermatitis:
• Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require Immunosuppressive/ immunomodulating drugs treatment(s) during the first 4 weeks of study treatment:
• Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, 200443, China

Location

MeSH Terms

Interventions

mycophenolic adenine dinucleotide; dupilumab; Sagittal Abdominal Diameter

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 5, 2024
• Study Start: January 5, 2024
• Primary Completion: August 20, 2025
• Study Completion: August 20, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)