Clinical trial NCT06193434: A First In Human (FIH) Study of IBI356 in Healthy Participants and in Atopic Dermatitis Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Atopic Dermatitis Patients
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of Adverse Event (AE) in SAD study.
timeFrame: Baseline to Week 20
measure: Occurrence of Adverse Event (AE) in MAD study.
timeFrame: Baseline to Week 36
measure: Occurrence of Serious Adverse Event (SAE) in SAD study.
timeFrame: Baseline to Week 20
measure: Occurrence of Serious Adverse Event (SAE) in MAD study.
timeFrame: Baseline to Week 36
measure: Changes in blood pressure mmHg (as a measure of safety and tolerability) in SAD study.
timeFrame: Baseline to Week 20
measure: Changes in blood pressure mmHg (as a measure of safety and tolerability) in MAD study.
timeFrame: Baseline to Week 36
measure: Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in SAD study.
timeFrame: Baseline to Week 20
measure: Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in MAD study.
timeFrame: Baseline to Week 36
measure: Changes in heart rate bpm (as a measure of safety and tolerability) in SAD study.
timeFrame: Baseline to Week 20
measure: Changes in heart rate bpm (as a measure of safety and tolerability) in MAD study.
timeFrame: Baseline to Week 36
measure: Changes in tympanic temperature °C in SAD study.
timeFrame: Baseline to Week 20
measure: Changes in tympanic temperature °C in MAD study.
timeFrame: Baseline to Week 36
measure: Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in SAD study.
timeFrame: Baseline to Week 20
measure: Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in MAD study.
timeFrame: Baseline to Week 36
Secondary outcomes:
measure: Area under the concentration time curve from time 0 to last observation (AUC 0-t).
timeFrame: Baseline to Week 16
measure: Maximum observed concentration (Cmax) after infusion.
timeFrame: Baseline to Week 16
measure: Systemic clearance after infusion (CL).
timeFrame: Baseline to Week 16
measure: Volume of distribution during the terminal phase after infusion(Apparent volume of distribution, V).
timeFrame: Baseline to Week 16
measure: Elimination half-life during the terminal phase after infusion(Half-life, t1/2).
timeFrame: Baseline to Week 16
measure: To assess immunogenicity: production of anti-drug antibodies (ADA) following SAD and Multiple ascending dose(MAD) doses.
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
Study officials:
References: