A Phase 1 Study to Evaluate the Pharmacokinetics and the Pharmacodynamics of TH9507 Administered Subcutaneously Once Daily for 14 Consecutive Days in HIV Positive Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Insulin-like Growth Factor-1 (IGF-1) Level at Day 14.
研究概览
简要总结
The primary objective of the study is to determine the PK (tesamorelin) and PD (IGF-1) profiles of tesamorelin after a single 2 mg subcutaneous administration and after repeated administration once daily for 14 consecutive days. Secondary objectives include the evaluation of the safety and tolerability of tesamorelin following multiple subcutaneous injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, smoker or non-smoker, ≥18 and ≤65 years of age.
- •HIV-positive with CD4 cell counts >100 cells/mm3 and viral load <10 000 copies/mL.
- •On stable antiretroviral therapy (ART) regimen for at least 8 weeks prior to the first study drug administration.
- •Body mass index (BMI) ≥ 20.0 kg/m
排除标准
- •Opportunistic infection or HIV-related disease within 3 months prior to study drug administration.
- •History of malignancy of any organ or tissue (with the exception of basal cell carcinoma of the skin, in situ carcinoma of the cervix and stable Kaposi not having required treatment for the past 6 months).
- •For male subjects, suspicion of prostate cancer.
- •For female subjects, history of breast cancer or strong family history (first degree relative) of breast cancer.
- •Known hypopituitarism, history of pituitary tumor/surgery, head irradiation or severe head trauma that had affected the somatotropic axis.
- •Use of any experimental or marketed GH or GRF/GHRH products, GH secretagogues, IGF-1, or insulin-like growth factor binding protein-3 (IGFBP-3) within 6 months prior to study drug administration and throughout the study.
- •Positive pregnancy test at screening.
研究组 & 干预措施
Tesamorelin
干预措施: Tesamorelin (Drug)
结局指标
主要结局
Insulin-like Growth Factor-1 (IGF-1) Level at Day 14.
时间窗: Day 14.
Area under the Plasma Concentration versus Time Curve (AUC) of Tesamorelin.
时间窗: Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.
Peak Plasma Concentration (Cmax) of Tesamorelin.
时间窗: Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.
Time to Maximum Plasma Concentration (Tmax) of Tesamorelin.
时间窗: Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.
Apparent Elimination Half-life (T1/2 el) of Tesamorelin.
时间窗: Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.
Plasma Clearance (CI/F) of Tesamorelin.
时间窗: Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.
Apparent Volume of Distribution (Vd/F) of Tesamorelin.
时间窗: Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.
Insulin-like Growth Factor-1 (IGF-1) Level at Day 1.
时间窗: Day 1.
Insulin-like Growth Factor-1 (IGF-1) Level at Day 7
时间窗: Day 7.
Insulin-like Growth Factor-1 (IGF-1) Level at Day 13.
时间窗: Day 13.
次要结局
- Number of Subjects with Adverse Events as a Measure of Safety and Tolerability(14 days)