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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Occurrence of Adverse Event (AE) in SAD study.
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of IBI356 in Healthy Participants and in Atopic Dermatitis Patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Dupilumab for MAD
干预措施: Dupilumab for MAD (Drug)
Placebo for MAD
干预措施: Placebo for MAD (Drug)
IBI356 for Single ascending dose (SAD)
干预措施: IBI356 for SAD (Drug)
IBI356 for Multiple ascending dose (MAD)
干预措施: IBI356 for MAD (Drug)
Placebo for SAD
干预措施: Placebo for SAD (Drug)
结局指标
主要结局
Occurrence of Adverse Event (AE) in SAD study.
时间窗: Baseline to Week 20
Occurrence of Adverse Event (AE) in MAD study.
时间窗: Baseline to Week 36
Changes in blood pressure mmHg (as a measure of safety and tolerability) in SAD study.
时间窗: Baseline to Week 20
Changes in blood pressure mmHg (as a measure of safety and tolerability) in MAD study.
时间窗: Baseline to Week 36
Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in SAD study.
时间窗: Baseline to Week 20
Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in MAD study.
时间窗: Baseline to Week 36
Changes in heart rate bpm (as a measure of safety and tolerability) in SAD study.
时间窗: Baseline to Week 20
Changes in heart rate bpm (as a measure of safety and tolerability) in MAD study.
时间窗: Baseline to Week 36
Changes in tympanic temperature °C in SAD study.
时间窗: Baseline to Week 20
Changes in tympanic temperature °C in MAD study.
时间窗: Baseline to Week 36
Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in SAD study.
时间窗: Baseline to Week 20
Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in MAD study.
时间窗: Baseline to Week 36
Occurrence of Serious Adverse Event (SAE) in SAD study.
时间窗: Baseline to Week 20
Occurrence of Serious Adverse Event (SAE) in MAD study.
时间窗: Baseline to Week 36
次要结局
- 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)