A First-in-Human, Single Ascending Dose, Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Subcutaneously Administered GX-G6 in Male Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Incidence, nature and severity of Adverse events
研究概览
简要总结
This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male subjects receiving ascending single s.c. doses of GX-G6
详细描述
A screening examination will be performed within 28 days prior to dosing. Eligible subjects will return to the study center in the morning of Day -1 and will remain in-patient until discharge about 98 hours after dosing (after oral glucose tolerance test in the morning of Day 5) if there are no safety issues. The s.c. injection will be administered in the morning of Day 1. Ambulatory visits will take place on Days 7, 9 and 12. A follow-up visit will take place on Day 15 and a final visit on Day 28.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male subjects aged between 18-50 years (both inclusive)
- •healthy subjects as determined by medical history, physical examination including vital signs, ECG and clinical laboratory testing
- •subjects who are able and willing to give written informed consent
- •male subjects must be using 2 acceptable methods for contraception (one of these methods should be a barrier method e.g. spermicide and condom) from start of dosing and refrain from fathering a child in the 3 months following dosing.
排除标准
- •History of:
- •clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing), especially allergy to macrolide antibiotics;
- •any clinically significant pancreatic, hepatic, renal, gastrointestinal, cardiovascular, respiratory, hematological, central nervous system diseases or other significant diseases which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation;
- •diabetes mellitus and thyroid dysfunction or other endocrine disorders;
- •malignancy;
- •substance abuse or addiction (alcohol, drugs) in the past 3 years.
- •Present Condition:
- •participation in a clinical investigation within the 30 days prior to the planned first drug administration or during this trial;
- •participation in this study at a previous dose level;
研究组 & 干预措施
Cohort 1: GX-G6 + placebo
Single administration of pre-determined dose (Level I) GX-G6 (6 subjects) and pre-determined dose (Level I) placebo (2 subjects)
干预措施: Gx-G6 (Drug)
Cohort 1: GX-G6 + placebo
Single administration of pre-determined dose (Level I) GX-G6 (6 subjects) and pre-determined dose (Level I) placebo (2 subjects)
干预措施: Placebo (Drug)
Cohort 2: GX-G6 + placebo
Single administration of pre-determined dose (Level II) GX-G6 (6 subjects) and pre-determined dose (Level II) placebo (2 subjects)
干预措施: Gx-G6 (Drug)
Cohort 2: GX-G6 + placebo
Single administration of pre-determined dose (Level II) GX-G6 (6 subjects) and pre-determined dose (Level II) placebo (2 subjects)
干预措施: Placebo (Drug)
Cohort 3: GX-G6 + placebo
Single administration of pre-determined dose (Level III) GX-G6 (6 subjects) and pre-determined dose (Level III) placebo (2 subjects)
干预措施: Gx-G6 (Drug)
Cohort 3: GX-G6 + placebo
Single administration of pre-determined dose (Level III) GX-G6 (6 subjects) and pre-determined dose (Level III) placebo (2 subjects)
干预措施: Placebo (Drug)
Cohort 4: GX-G6 + placebo
Single administration of pre-determined dose (Level IV) GX-G6 (6 subjects) and pre-determined dose (Level IV) placebo (2 subjects)
干预措施: Gx-G6 (Drug)
Cohort 4: GX-G6 + placebo
Single administration of pre-determined dose (Level IV) GX-G6 (6 subjects) and pre-determined dose (Level IV) placebo (2 subjects)
干预措施: Placebo (Drug)
(Optional) Cohort 5: GX-G6 + placebo
Single administration of pre-determined dose (Level V) GX-G6 (6 subjects) and pre-determined dose (Level V) placebo (2 subjects)
干预措施: Gx-G6 (Drug)
(Optional) Cohort 5: GX-G6 + placebo
Single administration of pre-determined dose (Level V) GX-G6 (6 subjects) and pre-determined dose (Level V) placebo (2 subjects)
干预措施: Placebo (Drug)
(Optional) Cohort 6: GX-G6 + placebo
Single administration of pre-determined dose (Level VI) GX-G6 (6 subjects) and pre-determined dose (Level VI) placebo (2 subjects)
干预措施: Gx-G6 (Drug)
(Optional) Cohort 6: GX-G6 + placebo
Single administration of pre-determined dose (Level VI) GX-G6 (6 subjects) and pre-determined dose (Level VI) placebo (2 subjects)
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence, nature and severity of Adverse events
时间窗: Throughout 4 weeks of study
All safety data will be evaluated descriptively
次要结局
- Pharmacodynamics(PD) variables(Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing)
- Pharmacokinetics(PK) variables(Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing)