A Randomized, Double-blinded, Placebo-controlled Phase 1 Study of a Single Dose of a Subcutaneous Ultra-Long-Acting Somatostatin Analog (TE-8214 Solution) to Investigate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety and tolerability of TE-8214 by the changes in physical examination findings
研究概览
简要总结
This is a Phase 1, first-in-human, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and PK of TE-8214 in healthy volunteers. The study will assess single ascending doses (SAD) of TE-8214.
详细描述
This study will enroll approximately 32 eligible healthy volunteers.
The main purpose of this study is to evaluate the safety, tolerability, and PK of single ascending doses (SAD) of TE-8214. This study will involve 4 groups (called Cohorts) of 8 participants at a time, with each group receiving a higher dose than the group before. A further 8 participants may be randomized into an optional cohort.
Each participant will receive 1 dose of TE-8214 solution or placebo in a randomized, double-blinded manner and the IP will be administered by subcutaneous injection into the abdomen. For each cohort, there will be a sentinel group and a main group. In the sentinel group, 2 participants will be randomized to TE-8214 or placebo at a ratio of 1:1. if there are no safety concerns this will be followed by the main group dosing at the discretion of the investigator.
The total duration of the study for each participant is up to 16 weeks which consists of 28 days for Screening, confinement period of 3 days with dosing on Day 1 and a follow up period until Day 84.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult, between 18 and 64 years old (inclusive, at the time of informed consent).
- •In good general health, as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at Screening and/or before the administration of IP at the discretion of the PI or designee.
- •Sign informed consent forms which include an explanation of the nature of the study, and the expected compliance with the requirements and restrictions of the study.
排除标准
- •Any abnormal laboratory values at Screening that are considered clinically significant by the PI or designee, or evidence of clinically significant abnormal findings at the physical examination at Screening, or significant illness within 2 weeks prior to dosing.
- •Have known allergies to octreotide, somatostatin analogs, or related compounds.
- •Have abnormal ECG findings at Screening that are considered by the PI or designee to be clinically significant, including, but not limited to: PR interval > 220 ms, QTcF > 450 ms (males) or > 470 ms (females), and/or arrythmias.
- •History of clinically significant allergy (including anaphylaxis), history or clinical evidence of pancreatic injury or pancreatitis.
- •History of gallstones, prior cholecystectomy is not exclusionary.
- •History of B12 deficiency.
- •History of hypothyroidism, or TSH > 4 mIU/L at Screening.
- •Any individual with a known history of diabetes mellitus, or HbA1c ≥ 6.5% at Screening. Individuals with previous gestational diabetes are eligible to participate, provided they do not currently have diabetes.
- •Women of childbearing potential (WOCBP) must be non-pregnant and must use an acceptable, highly effective double contraception from Screening until study completion.
- •Males must use an acceptable, highly effective double contraception from Screening until study completion and must not donate sperm until at least 90 days after the last dose of study drug.
- •Anything that the PI considers that would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.
- •Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site.
研究组 & 干预措施
SAD Cohort
Each participant will receive TE-8214 administered by subcutaneous injection across 5 Cohorts (Cohort 5 optional)
干预措施: TE-8214 - SAD (Drug)
Placebo
Each participant will receive matching volume doses of Placebo administered by subcutaneous injection
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of TE-8214 by the changes in physical examination findings
时间窗: At Screening, Day -1, Day 2, Day 8, Day 28, Day 56, Day 84 post dose
Safety and tolerability of TE-8214 by the incidence of clinically significant laboratory findings
时间窗: From Screening until EOS/ET (Day 84) post dose
Safety and tolerability of TE-8214 by the incidence of treatment-emergent adverse events (TEAEs)
时间窗: From administration of IP on Day 1 until the EOS/ET visit (Day 84) post dose
Safety and tolerability of TE-8214 by the incidence of treatment-related adverse events
时间窗: From screening until the EOS/ET visit (Day 84) post dose
Safety and tolerability of TE-8214 by the changes in ECG findings
时间窗: At Screening, Day -1, Day 1, Day 2, Day 4, Day 8, Day 14, Day 28, Day 56, Day 84 post dose
Safety and tolerability of TE-8214 by the incidence of injection site reactions (ISRs)
时间窗: On Day 1, 0 hour, 6 hours, 12 hours, 24 hours, 48 hours,72 hours, 96 hours, 168 hours post dose
次要结局
- PK Parameters: Time to maximum observed concentration (Tmax)(On Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Day 56, Day 84 post dose)
- PK Parameters: Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last)(On Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Day 56, Day 84 post dose)
- PK Parameters: Maximum observed concentration (Cmax)(On Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Day 56, Day 84 post dose)