NCT06213844已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IBI3002 in Healthy Participants and Participants With Mild to Moderate Asthma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of participants with AEs/SAEs
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled, phase 1, single-ascending-dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3002 in healthy participants and mild to moderate asthmatics. Subjects will be randomly assigned to different dosages of IBI3002 and matched placebo groups. The entire trial cycle includes a 4-week screening period, 1-day treatment period and 5-week follow-up period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedures.
- •Participants must be between 18 and 55 years old, inclusive.
- •Participants must have a body mass index (BMI) between 18 to 32 kg/m2, inclusive.
- •Participants of childbearing potential and their partners should use highly effective methods of birth control during the study and until 6 months after the study.
- •Participants with asthma must have:
- •Documented physician diagnosis of asthma for at least 12 months prior to screening and confirmed by the investigator;
- •Elevated FeNO defined as ≥ 25ppb;
- •Documented and stable GINA 2023 recommended Step 1~3 controller treatment (defined as ≤ 250μg fluticasone propionate dry powder formulation equivalent total daily dose of ICS, alone or in combination with LABA) for the last 3 months prior to screening;
- •Pre-BD FEV1 ≥ 60% of prediction and Post-BD FEV1/forced vital capacity (FVC) > 70%.
排除标准
- •History of allergies to any components of IBI3002 or placebo.
- •History of blood or needle sickness, or those who cannot tolerate venipuncture.
- •Female participants who are pregnant or breastfeeding at screening or randomization.
- •History of participating in a clinical trial within 1 month or 5 half-lives of the test drug (whichever is longer) prior to randomization, or those who are currently participating in a clinical trial.
- •History of severe infection or significant injury within 6 months, or surgery within 3 months, or any infection requiring systemic medication within 1 month prior to screening or randomization.
- •History of live or attenuated vaccination within 1 month prior to randomization, or those who plan to be vaccinated during the study.
- •For asthmatics only: history of a life-threatening asthma attack that required mechanical ventilation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years prior to randomization.
- •For asthmatics only: history of asthma worsen or exacerbation resulting in emergency room (ER) visits or overnight hospitalizations, or an increase in asthma maintenance therapy, or use of systemic glucocorticoids within the last 3 months prior to randomization.
研究组 & 干预措施
Placebo
Placebo Comparator
Single dose of Placebo administered subcutaneously on Day 1
干预措施: Placebo (Drug)
IBI3002
Experimental
Single dose of IBI3002 (Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, Dosage 6) administered subcutaneously on Day 1
干预措施: IBI3002 (Drug)
结局指标
主要结局
Number of participants with AEs/SAEs
时间窗: Baseline up to Day 36
Incidence of adverse events and severe adverse events
次要结局
- PK parameter: Cmax(Baseline up to Day 36)
- PK parameter: AUC(Baseline up to Day 36)
- PD profile (only in asthmatics): TARC (CCL17)(Baseline up to Day 36)
- Clinical profile (only in asthmatics): Spirometry(Baseline up to Day 36)
- PK parameter: tmax(Baseline up to Day 36)
- PD profile (only in asthmatics): IgE(Baseline up to Day 36)
- Immunogenicity profiles(Baseline up to Day 36)
- PD profile (only in asthmatics): Eosinophil(Baseline up to Day 36)
- Clinical profile (only in asthmatics): FeNO(Baseline up to Day 36)
- PD profile (only in asthmatics): IL-13(Baseline up to Day 36)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase 1 Study to Assess the Safety, Tolerability and PK of IV TP-271PneumoniaNCT02724085Tetraphase Pharmaceuticals, Inc.57
已完成
1 期
Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor AntidoteHealthyNCT03218241Portola Pharmaceuticals32
终止
1 期
Single Dose Study of ANX005 in Healthy VolunteersSafety and Tolerability in Healthy VolunteersNCT03010046Annexon, Inc.27
已完成
1 期
Safety and Tolerability of Escalating Doses of BPN-14967 in Healthy AdultsHealthy VolunteersNCT04005807Belite Bio, Inc40
已完成
1 期
Phase 1, Single-Dose and Multiple-Dose Continuous Intravenous Infusions of TNP-2092 for Injection in Healthy Chinese ParticipantsAcute Bacterial Skin and Skin Structure Infection (ABSSSI)Prosthetic Joints Infection (PJI)NCT06394518TenNor Therapeutics Inc.32