A Study to Investigate the Safety, Tolerability and Pharmacokinetics 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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants; Atopic Dermatitis Patients
• Intervention / Treatment: Drug: IBI356 for SAD; Drug: IBI356 for MAD; Drug: Placebo for MAD; Drug: Dupilumab for MAD; Drug: Placebo for SAD

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bingjing Feng; Phone Number: +86 18361923769; Email: bingjing.feng@innoventbio.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200443
      • Recruiting
      • Shanghai skin disease hospital
      • Contact: Yuling Shi; Phone Number: 021-36803156; Email: shiyuling1973@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy participants:

   1. Aged 18 to 45 years,
   2. Weight 50 to 120 kgs,
   3. Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
   4. No child-bearing potential during the trial and within 6 months after SAD doses, and adequate contraceptive measures can be taken.

2. Atopic dermatitis:

   1. Aged 18 to 75 years,
   2. body mass index (BMI): 18.0 - 32.0 kg/m2,
   3. Atopic Dermatitis (AD) for 1 year or longer at Baseline,
   4. Eczema Area and Severity Index (EASI) of 16 or higher at baseline,
   5. Investigator Global Assessment (IGA) of 3 or 4 at baseline,
   6. AD involvement of 10 percent or more of body surface area at Baseline,
   7. Documented history, within 1 year before Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments,
   8. Must have applied a stable dose of topical bland emollient at least twice daily for at least 7 consecutive days before Baseline.

Exclusion Criteria:

1. History of relevant drug allergies.
2. 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

3. Healthy participants:

   1. History of alcohol abuse or drug addiction within 1 year before screen,
   2. Positive drug and alcohol screen at screening.

4. Atopic dermatitis:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI356 for Single ascending dose (SAD)	Drug: IBI356 for SAD; Receive IBI356 in a single dose.
Experimental: IBI356 for Multiple ascending dose (MAD)	Drug: IBI356 for MAD; Receive IBI356 in a multiple dose.
Placebo Comparator: Placebo for MAD	Drug: Placebo for MAD; Receive placebo in a multiple dose.
Active Comparator: Dupilumab for MAD	Drug: Dupilumab for MAD; Active comparator
Placebo Comparator: Placebo for SAD	Drug: Placebo for SAD; Receive placebo in a single dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
To assess immunogenicity: production of anti-drug antibodies (ADA) following SAD and Multiple ascending dose(MAD) doses.	Baseline to Week 16

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Estimated): September 27, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: CIBI356A101CN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No