A First-In-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GFB-024 as a Single Dose in Healthy Overweight and Obese Participants and as Multiple Doses in Participants With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Safety and tolerability following single ascending doses of GFB-024
研究概览
简要总结
GFB-024 is intended for use in patients with kidney disease such as diabetic nephropathy. This study is the first time GFB-024 has been used in humans. The first part of the study will assess the safety of a single dose of GFB-024 in healthy overweight and obese volunteers and the effect of GFB-024 on the body as compared to an inactive placebo medication. The second part of the study will assess the safety of repeated doses of GFB-024 in participants with Type 2 diabetes and the effect of GFB-024 on the body as compared to an inactive placebo medication.
详细描述
This is a first-in-human study. It is intended to provide the initial safety, pharmacokinetics (PK), and pharmacology data for GFB-024 in humans. This study will comprise a single ascending dose (SAD) escalation component in healthy overweight and obese volunteer participants and a repeat-dose component to confirm repeat-dose safety, tolerability, PK, and immunogenicity in participants with Type 2 diabetes mellitus. It will also explore potential cannabinoid-1 receptor (CB1) activity, participant selection, pharmacodynamics, and differential response biomarkers.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 75 years of age at the time of signing informed consent.
- •Body mass index (BMI) between 25.0 and 40.0 kg/m2, inclusive, at Screening.
- •Female participants will be of non-childbearing potential.
- •Male participants will agree to use contraception while on study intervention and for at least 6 months after the last dose of study intervention.
- •SAD cohorts only: Participants must be in good health.
- •Repeat-dose cohort only: Type 2 diabetes mellitus (T2DM) treated with lifestyle modification or metformin, and in otherwise good health except for well-controlled common conditions associated with T2DM, such as hypertension and dyslipidemia.
排除标准
- •History of, or treatment for, psychiatric illness, including anxiety or depression within 5 years of the Screening visit.
- •Participants with a history of attempted suicide or clinically significant suicidal ideation.
- •History of cardiovascular disease.
- •Blood pressure >155 mmHg systolic or >95 mmHg diastolic.
- •History of alcoholism or drug/chemical abuse within 2 years prior to Screening.
- •Alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1.5 oz (45 mL) liquor, or 5 oz (150 mL) wine.
- •History of significant hypersensitivity, intolerance, or allergy to more than one class of drugs.
- •Positive hepatitis panel and/or positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.
- •SAD cohorts only: Fasting glucose >126 mg/dL.
研究组 & 干预措施
GFB-024 SAD Active
Single ascending dose arm of GFB-024 treatment
干预措施: GFB-024 (Drug)
SAD Placebo
Single ascending dose arm of placebo treatment
干预措施: Placebo (Drug)
GFB-024 Repeat-dose Active
Repeat-dose arm of GFB-024 treatment
干预措施: GFB-024 (Drug)
Repeat-dose Placebo
Repeat-dose arm of placebo treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability following single ascending doses of GFB-024
时间窗: Approximately 10 weeks
Number of participants with serious and other nonserious adverse events
次要结局
- Safety and tolerability following repeated doses over 4 weeks of GFB-024(Approximately 13 weeks)
- Characterize PK of GFB-024 following single ascending doses (Cmax)(Approximately 10 weeks)
- Characterize PK of GFB-024 following single ascending doses (AUClast)(Approximately 10 weeks)
- Characterize PK of GFB-024 following repeated doses (Cmax)(Approximately 13 weeks)
- Characterize PK of GFB-024 following repeated doses (AUClast)(Approximately 13 weeks)
- Characterize the incidence and persistence of immunogenicity of GFB-024 following single ascending doses(Approximately 10 weeks)
- Characterize the incidence and persistence of immunogenicity of GFB-024 following repeated doses(Approximately 13 weeks)