A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMF-650 in Otherwise Healthy Overweight or Obese Participants.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assess safety and tolerability of BMF-650
研究概览
简要总结
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMF-650 in Otherwise Healthy Overweight or Obese Participants.
详细描述
This is a single center, double-blind, randomized, placebo-controlled, first-in-human (FIH) study of BMF-650, an oral non-peptide GLP-1 receptor agonist administered to otherwise healthy overweight or obese participants. Part 1 is a single ascending dose (SAD) study and Part 2 is a multiple ascending dose (MAD) study.
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)
盲法说明
This is a double-blind study. Treatment assignment will not be known to the participants, the sponsor or the staff who are involved in the clinical evaluation of the participants and the analysis of data as indicated in the blinding plan. If appearance matching of the placebo is not possible then use of masking and/or unblinded dosing teams will be used to preserve the study blind.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
- •Must be willing and able to comply with all study requirements
- •Healthy males or non-pregnant, non-lactating healthy females with obesity or overweight.
- •For Part 1 (SAD cohorts), BMI of 25.0 to 40.0 kg/m2 as measured at screening, with no chronic health conditions.
- •For Part 2 (MAD cohorts), BMI of 30.0 to 45.0 kg/m2, as measured at screening with no chronic health conditions.
- •Have a stable body weight (less than or equal to 5% body weight gain or loss) for 3 months prior to screening.
- •HbA1c ≤ 6.5%
排除标准
- •Medical/Surgical History and Mental Health
- •Known self or family history (first-degree relative) of medullary thyroid cancer and/or multiple endocrine neoplasia Type 2 (MEN2).
- •History of stomach or intestinal surgery or resection and/or gastroparesis (except that appendectomy and/or hernia repair will be allowed).
- •Significant history of or currently have major depressive disorder or psychiatric disorder or suicidal ideation within the last 2 years.
- •Severe uncontrolled treated or untreated hypertension (systolic blood pressure [BP] >150 mmHg or diastolic BP >90 mmHg).
- •Mean QTcF interval greater than 450 msec on triplicate ECGs.
- •Diagnostic Assessments
- •Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
- •eGFR of <60 mL/min/1.73 m2
- •AST, ALT or total bilirubin > ULN
- •Lipase and/or amylase > ULN
- •Calcitonin ≥20 ng/L
- •Prior Study Participation
- •Participants who have received any IMP in a clinical research study within 5 half -lives or within 30 days prior to first dose
- •Prior and Concomitant Medication
- •Participants who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than HRT/hormonal contraception) in the 14 days before first IMP administration
- •Use of prescription or over-the-counter medications known to significantly prolong the QT or QTc interval is excluded.
- •Currently dieting (formal weight loss program) and/or are currently using or have used within 2 months of screening any drugs for weight management
- •Participants who have previously used GLP-1 receptor agonist, or GIP/GLP-1 dual receptor agonists, or any investigational medicine containing a GLP-1 and/or GIP receptor agonist in the 6 months prior to first IMP administration
研究组 & 干预措施
Part 1 SAD Cohort 3 (Regimen D)
BMF-650 Tablets 50 mg or matching placebo in fasted state
干预措施: BMF-650 (Drug)
Part 1 SAD Cohort 1 (Regimen A)
BMF-650 Tablets 10 mg or matching placebo in fasted state
干预措施: BMF-650 (Drug)
Part 2 MAD Cohort 3 (Regimen J)
BMF-650 Tablets or matching placebo in fasted state
75 mg QD for 7 days; 150 mg QD for 7 days; 300 mg QD for 28 days.
干预措施: BMF-650 (Drug)
Part 1 SAD Cohort 5 (Regimen G) (Optional)
BMF-650 Tablets 200 mg or matching placebo in fasted state
干预措施: BMF-650 (Drug)
Part 1 SAD Cohort 2 (Regimen B and C)
Regimen B:
BMF-650 Tablets 25 mg or matching placebo in fasted state
Regimen C:
BMF-650 Tablets 25 mg or matching placebo in fed state (high-fat breakfast 30 minutes before BMF-650 or placebo is administered)
干预措施: BMF-650 (Drug)
Part 1 SAD Cohort 4 (Regimen E and F) (Optional)
Regimen E:
BMF-650 Tablets 100 mg or matching placebo in fasted state
Regimen F:
BMF-650 Tablets 100 mg or matching placebo in fed state (high-fat breakfast 30 minutes before BMF-650 or placebo is administered)
干预措施: BMF-650 (Drug)
Part 2 MAD Cohort 1 (Regimen H)
BMF-650 Tablets or matching placebo in fasted state
10 mg QD for 7 days; 25 mg QD for 7 days; 50 mg QD for 7 days; 100 mg QD for 21 days.
干预措施: BMF-650 (Drug)
Part 2 MAD Cohort 2 (Regimen I)
BMF-650 Tablets or matching placebo in fasted state
50 mg QD for 7 days; 100 mg QD for 7 days; 200 mg QD for 28 days.
干预措施: BMF-650 (Drug)
Part 2 MAD Cohort 4 (Regimen K) (Optional)
BMF-650 Tablets or matching placebo in fasted state
75 mg QD for 7 days; 200 mg QD for 7 days; 400 mg QD for 28 days.
干预措施: BMF-650 (Drug)
结局指标
主要结局
Assess safety and tolerability of BMF-650
时间窗: 6 weeks (Part 1) and 11 weeks (Part 2)
Incidence of adverse events (AEs)
次要结局
- Evaluate PK and food effect of BMF-650 in fed and fasted states(2 weeks (Part 1) and 6 weeks (Part 2))
- Assess the impact of multiple ascending doses of BMF-650 on weight (Part 2 only)(6 weeks)