A Double-blind, Randomized, Placebo Controlled, Combined Single (Part A) and Multiple (Part B, C) Ascending Dose, Phase 1 Study to Investigate the Safety, Tolerability and Pharmacokinetic and Pharmacodynamics Following Subcutaneous Injections of PG-102(MG12) in Healthy Adult and Obesity Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Number of participants with clinically significant abnormalities in vital signs for Part A
研究概览
简要总结
This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B, C) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants.
This study will be conducted in 3 Parts (Part A, B and C), with up to 5 cohorts in each part.
详细描述
Part A (SAD):
In Part A, subjects will receive a single dose of study drug, and the safety and efficacy of PG-102(MG12) will be evaluated in healthy subjects.
Part B (MAD):
In Part B, subjects will receive once-weekly doses of the study drug for 4 weeks, and the safety and efficacy of PG-102(MG12) will be evaluated in otherwise healthy overweight adult subjects.
Part C (MAD):
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants, aged 18 to 65 years inclusive at the time of signing informed consent
- •Body mass index (BMI) of 18 to 30kg/m2 (inclusive) for Part A, Body mass index (BMI) of 25 to 30kg/m2 (inclusive) for Part B and Body mass index (BMI) 30 kg/m² or higher for Part C
- •[Exclusion Criteria]
- •History of administration of prescription drugs, herbal medicines, over-the-counter drugs, or vitamin supplements within 10 days prior to the study or history of the following drugs and/or other foods within 90 days prior to screening:
- •Drugs that affect body weight (such as obesity medications, psychiatric drugs, beta blockers, diuretics, contraceptives, female hormones, proton-pump inhibitors (PPIs), H2 receptor antagonists, health functional foods/supplements, and formulas designed for weight control).
- •Drugs that have the potential to impact blood sugar, liver fat, and intestinal microorganisms (including GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, thiazolidinediones (TZDs), fish oil, polyunsaturated fatty acids (PUFA), and ursodeoxycholic acid (UDCA)), as well as individuals who are currently using insulin.
- •History of gastrointestinal diseases (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs.
- •History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy.
- •History of surgical treatment for obesity within 2 years (example: bariatric surgery, gastric banding etc) or gastrointestinal procedures for weight loss (including LAP-BAND®), or uncontrolled gastrointestinal disorders at Screening (e.g., peptic ulcer, gastroesophageal reflux disease).
排除标准
- 未提供
研究组 & 干预措施
Cohort A4 - Single Ascending Dose
PG-102(MG12) Dose 4 (N=8) Subcutaneous injection
干预措施: PG-102(MG12) (Drug)
Cohort A4 - Single Ascending Dose
PG-102(MG12) Dose 4 (N=8) Subcutaneous injection
干预措施: Placebo (Other)
Cohort A3 - Single Ascending Dose
PG-102(MG12) Dose 3 (N=8) Subcutaneous injection
干预措施: PG-102(MG12) (Drug)
Cohort A1 - Single Ascending Dose
PG-102(MG12) Dose 1 (N=8) Subcutaneous injection
干预措施: PG-102(MG12) (Drug)
Cohort A1 - Single Ascending Dose
PG-102(MG12) Dose 1 (N=8) Subcutaneous injection
干预措施: Placebo (Other)
Cohort A2 - Single Ascending Dose
PG-102(MG12) Dose 2 (N=8) Subcutaneous injection
干预措施: PG-102(MG12) (Drug)
Cohort A2 - Single Ascending Dose
PG-102(MG12) Dose 2 (N=8) Subcutaneous injection
干预措施: Placebo (Other)
Cohort A3 - Single Ascending Dose
PG-102(MG12) Dose 3 (N=8) Subcutaneous injection
干预措施: Placebo (Other)
Cohort A5 - Multiple Ascending Dose
PG-102(MG12) Dose 5 (N=8) Subcutaneous injection
干预措施: PG-102(MG12) (Drug)
Cohort A5 - Multiple Ascending Dose
PG-102(MG12) Dose 5 (N=8) Subcutaneous injection
干预措施: Placebo (Other)
Cohort B1 - Multiple Ascending Dose
PG-102(MG12) Dose 1 (N=6) Subcutaneous injection
干预措施: PG-102(MG12) (Drug)
Cohort B1 - Multiple Ascending Dose
PG-102(MG12) Dose 1 (N=6) Subcutaneous injection
干预措施: Placebo (Other)
Cohort B2 - Multiple Ascending Dose
PG-102(MG12) Dose 1~5 (N=6) Subcutaneous injection
干预措施: PG-102(MG12) (Drug)
Cohort B2 - Multiple Ascending Dose
PG-102(MG12) Dose 1~5 (N=6) Subcutaneous injection
干预措施: Placebo (Other)
Cohort B3 - Multiple Ascending Dose
PG-102(MG12) Dose 1~5 (N=6) Subcutaneous injection
干预措施: PG-102(MG12) (Drug)
Cohort B3 - Multiple Ascending Dose
PG-102(MG12) Dose 1~5 (N=6) Subcutaneous injection
干预措施: Placebo (Other)
Cohort S - Multiple Ascending Dose
PG-102(MG12) Optimal Dose (N=6) Subcutaneous injection
干预措施: PG-102(MG12) (Drug)
Cohort S - Multiple Ascending Dose
PG-102(MG12) Optimal Dose (N=6) Subcutaneous injection
干预措施: Placebo (Other)
Cohort C1 - Multiple Ascending Dose
PG-102(MG12) Dose 1 (N=12) Subcutaneous injection
干预措施: PG-102(MG12) (Drug)
Cohort C1 - Multiple Ascending Dose
PG-102(MG12) Dose 1 (N=12) Subcutaneous injection
干预措施: Placebo (Other)
Cohort C2 - Multiple Ascending Dose
PG-102(MG12) Dose 1 (N=12) Subcutaneous injection
干预措施: PG-102(MG12) (Drug)
Cohort C2 - Multiple Ascending Dose
PG-102(MG12) Dose 1 (N=12) Subcutaneous injection
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants with clinically significant abnormalities in vital signs for Part A
时间窗: Baseline to Day 29
Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)
Number of participants with clinically significant abnormalities in vital signs for Part B
时间窗: Baseline to Day 57
Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)
Number of participants with treatment-emergent adverse events (TEAEs) for Part A
时间窗: Baseline to Day 29
Number of participants with treatment-emergent adverse events (TEAEs)
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B
时间窗: Baseline to Day 57
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Number of participants with treatment-emergent adverse events (TEAEs) for Part B
时间窗: Baseline to Day 57
Number of participants with treatment-emergent adverse events (TEAEs)
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A
时间窗: Baseline to Day 29
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A
时间窗: Baseline to Day 29
Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)
Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B
时间窗: Baseline to Day 57
Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)
次要结局
- Terminal half-life (t1/2) for Part A(Baseline to Day 29)
- Maximum plasma concentration (Cmax) for Part B(Baseline to Day 57)
- Maximum plasma concentration (Cmax) for Part A(Baseline to Day 29)
- Time to maximum plasma concentration (tmax) for Part A(Baseline to Day 29)
- Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A(Baseline to Day 29)
- Terminal half-life (t1/2) for Part B(Baseline to Day 57)
- Time to maximum plasma concentration (tmax) for Part B(Baseline to Day 57)
- Apparent total clearance (CL/F) for Part A(Baseline to Day 29)
- Apparent total clearance (CL/F) for Part B(Baseline to Day 57)
- Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B(Baseline to Day 57)