A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose Study to Assess Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Mean change from baseline in clinical laboratory values, vital signs, clinical findings from physical exam and ECG abnormalities
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human (FIH) study to evaluate the safety, tolerability, food effect (FE), pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered XW014 in healthy participants and patients with T2DM. This study will consist of 4 parts: a Single Ascending Dose (SAD) part in healthy subjects (Part A), and Multiple Ascending Dose (MAD) parts in healthy subjects with elevated BMI (Part B and Part B-EXT) and patients with T2DM [Optional] (Part C).
详细描述
Part A - SAD, including FE cohort: Healthy participants with BMI in the range of ≥18.5 kg/m2 to ≤35.0 kg/m2 will be randomized to receive a single oral dose of either XW014 or placebo in each of the planned SAD cohorts.
Part B and Part B-EXT - MAD in healthy participants with elevated BMI: Healthy subjects with BMI in the range of ≥30 kg/m2 to ≤40.0 kg/m2 will be randomized to receive oral doses of XW014 or placebo in each of the planned MAD cohorts.
Part C - MAD in patients with T2DM: Patients with T2DM for at least 6 months, having hemoglobin A1c (HbA1c) in the range of 6.5% to 8.5% will be randomized to receive oral doses of XW014 or placebo in each of the planned MAD cohorts.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability and willingness to participate in the study, give written informed consent, and comply with the study restrictions and all protocol procedures
- •Sex: male or female
- •Weight: >50 kg, inclusive, at screening
- •For Part A 18 to 70 years, inclusive, at screening
- •For Part B, Part B-EXT, and C 18 to 55 years, inclusive, at screening
- •Body Mass Index
- •For Part A: ≥18.5 kg/m2 and ≤35.0 kg/m2, inclusive, at screening
- •For Part B and Part B-EXT: ≥30.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening
- •For Part C: ≥25.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening
- •Patients with T2DM for at least 6 months, having HbA1c of 6.5% to 8.5% (Part C)
排除标准
- •History or clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurologic, renal, pancreatic, immunologic, dermatologic, endocrine, genitourinary, or hematologic system
- •Uncontrolled hypertension
- •History of type 1 diabetes mellitus
- •History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 or subjects with suspected medullary thyroid carcinoma
- •Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the investigational product
研究组 & 干预措施
SAD Cohort A - XW014
Single oral XW014 administration
干预措施: XW014 (Drug)
SAD Cohort A - Placebo
Single oral placebo administration
干预措施: Placebo (Drug)
MAD Cohort B - XW014
MAD in Healthy Subjects with Elevated BMI
干预措施: XW014 (Drug)
MAD Cohort B - Placebo
MAD in Healthy Subjects with Elevated BMI
干预措施: Placebo (Drug)
MAD Cohort C - XW014
MAD in Patients with T2DM
干预措施: XW014 (Drug)
MAD Cohort C - Placebo
MAD in Patients with T2DM
干预措施: Placebo (Drug)
MAD Cohort B-EXT - XW014
MAD in Healthy Subjects with Elevated BMI
干预措施: XW014 (Drug)
MAD Cohort B-EXT - Placebo
MAD in Healthy Subjects with Elevated BMI
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from baseline in clinical laboratory values, vital signs, clinical findings from physical exam and ECG abnormalities
时间窗: 11 weeks
Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)
时间窗: 11 weeks
次要结局
未报告次要终点