NCT06462118已完成1 期
A Phase 1, Open-Label, Randomized, Single Dose Study to Evaluate the Effect of Injection Site on the Pharmacokinetics of Astegolimab in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 3
- 主要终点
- Maximum serum concentration (Cmax) of astegolimab
研究概览
简要总结
The main objective is to study how astegolimab may behave in the body when injected subcutaneously into the abdomen, thigh, or upper arm in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Body weight of ≥50 kg to ≤110 kg with body mass index (BMI) range 18.0 to 30.0 kg/m2 (inclusive) at screening
排除标准
- •History of significant hypersensitivity or severe allergic reaction, including anaphylaxis, to any drug compound, food, or other substance
- •Any immunization or vaccination 14 days prior to the Check-in (Day -1) or plans to obtain any immunization or vaccination within 30 days after the Check-in
- •Any surgical procedure (except for minor surgeries) within 28 days prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- •Donation of blood from 30 days prior to screening through study completion or end of trial, inclusive, or of plasma from 2 weeks prior to screening through study completion or end of trial, inclusive
- •History of immunodeficiency, including but not limited to, human immunodeficiency virus (HIV) infection
- •History of active or untreated latent tuberculosis
- •History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
- •Unstable cardiac disease, myocardial infarction, or New York Heart Association Class 3 or 4 heart failure within 12 months prior to screening
- •History or presence of clinically significant ECG abnormalities at screening or check-in (Day -1)
- •Positive for Hepatitis B or Hepatitis C (HCV)
- •Tattoo(s) or scarring at or near the site of injection (abdomen, front and middle thigh, or upper arm) or any other condition which may interfere with the injection site examination (as determined by the Investigator)
研究组 & 干预措施
Treatment A
Experimental
Participants will receive one subcutaneous (SC) dose in the abdomen.
干预措施: Astegolimab (Drug)
Treatment B
Experimental
Participants will receive one subcutaneous (SC) dose in the thigh.
干预措施: Astegolimab (Drug)
Treatment C
Experimental
Participants will receive one subcutaneous (SC) dose in the upper arm.
干预措施: Astegolimab (Drug)
结局指标
主要结局
Maximum serum concentration (Cmax) of astegolimab
时间窗: Approximately 85 days
Area under the curve from Hour 0 to the time of last measurable concentration (AUC0-t) of astegolimab
时间窗: Approximately 85 days
AUC extrapolated to infinity (AUC0-infinity) of astegolimab
时间窗: Approximately 85 days
次要结局
- Incidence of anti-drug antibodies (ADAs)(Approximately 85 days)
- Relative bioavailability (F%) for thigh injection of astegolimab(Approximately 85 days)
- Apparent volume of distribution during the terminal elimination phase (Vz/F) of astegolimab(Approximately 85 days)
- Time to maximum serum concentration (Tmax) of astegolimab(Approximately 85 days)
- F% for upper arm injection of astegolimab(Approximately 85 days)
- Half-life (T1/2) of astegolimab(Approximately 85 days)
- Apparent systemic clearance (CL/F) of astegolimab(Approximately 85 days)
研究者
研究点 (3)
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