A Phase 1 Randomized, Double-blind, Placebo-controlled Single-ascending Dose and Multiple-ascending Dose (SAD and MAD) Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Novel Glucagon-like Peptide-1 Receptor Agonist (GLP-1RA) BLX-7006 in Healthy Adults With a Body Mass Index (BMI) of 20 - 35 kg/m2
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Number of participants who experienced Adverse Events (AEs)
研究概览
简要总结
This study will test an oral medicine called BLX-7006, which acts like the hormone Glucagon-like Peptide-1 (GLP-1) to help control blood sugar and body weight. Current GLP-1 medicines are given by injection. This study will see if BLX-7006 is safe, how the body processes it, and whether food changes how it is absorbed. The main goal is to see if BLX-7006 is safe and well tolerated. Secondary objectives of the study will measure how BLX-7006 moves through the body after an oral dose, including how quickly it is absorbed, how long it stays in the blood, and how the body removes it. It will also look at how the drug affects the body by looking at markers of glucose metabolism.
详细描述
This is a Phase 1, single-center, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the effect of food on the PK of BLX-7006, a novel oral small-molecule GLP-1 receptor agonist, in healthy adult volunteers. The study consists of three parts: single ascending dose (SAD), food effect (FE), and multiple ascending dose (MAD) assessments.
Study Rationale and Objectives:
BLX-7006 is being developed as an oral alternative to currently available injectable GLP-1 receptor agonists used for the treatment of metabolic diseases such as type 2 diabetes mellitus and obesity. Oral delivery of BLX-7006 may improve convenience and treatment adherence while maintaining the metabolic benefits of GLP-1 agonism. This Phase 1 study is designed to characterize the initial safety profile, define the PK properties of BLX-7006, evaluate preliminary PD biomarkers of glucose metabolism, and determine the impact of a high-fat meal on drug absorption.
Study Design Overview:
The study will enroll approximately 76 healthy adults across three sequential parts.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Healthy males or females, 18-65 years, BMI 20-35 kilograms/meter² (kg/m²), weight ≥50 kilograms (kg).
- •Normal or clinically acceptable labs, vital signs
- •HbA1c <6.5%, non-fasting glucose 4.0-7.8 milimol/Liter (mmol/L)
- •Willing to follow contraception requirements, avoid alcohol, nicotine, and blood donation per protocol, and comply with all study visits and procedures.
排除标准
- •History of diabetes, clinically significant cardiovascular, hepatic, renal, gastrointestinal, psychiatric, or neurologic disease, or abnormal labs/Echocardiograms (ECG) deemed clinically relevant.
- •Prior gastrointestinal (GI) surgery affecting absorption (e.g., gastric bypass) or chronic GI disorders.
- •History or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2); malignancy within 5 years (except treated basal cell or in situ cervical cancer).
- •History of severe allergic reactions, seizures, or psychiatric hospitalization; positive drug, alcohol, or cotinine test.
- •Use of prescription drugs, Over the counter (OTC) /herbal supplements
- •Participation in another clinical trial or blood donation within 30 days (or 5 half-lives of prior drug).
- •Any condition or history that may compromise safety, study conduct, or compliance, in the opinion of the Investigator.
研究组 & 干预措施
BLX-7006 Oral Dose
Participants will receive oral BLX-7006 as a single dose (in Part 1 or 2) or once daily for 7 days (in Part 3).
干预措施: BLX-7006 (Drug)
Placebo to match BLX-7006
Participants will receive an oral placebo that looks like BLX-7006 but does not contain active drug as a single dose (in Part 1 or 2) or once daily for 7 days (in Part 3).
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants who experienced Adverse Events (AEs)
时间窗: From first dose through End of Study (up to ~28 days per participant)
The safety and tolerability of oral BLX-7006 administration will be evaluated based on the incidence of adverse effects in subjects, as assessed according to CTCAE v5.0. The number of participants who experience an AE will be reported.
Number of participants who experienced Serious Adverse Events (SAEs)
时间窗: From first dose through End of Study (up to ~28 days per participant)
The safety and tolerability of oral BLX-7006 administration will be evaluated based on the incidence of SAE in subjects, as assessed according to CTCAE v5.0. The number of participants who experience a SAE will be reported.
Number of participants who experienced Treatment-Related Adverse Avents (TRAEs)
时间窗: From first dose through End of Study (up to ~28 days per participant)
The safety and tolerability of oral BLX-7006 administration will be evaluated based on the incidence of TRAEs in subjects, as assessed according to CTCAE v5.0. The number of participants who experience a TRAE will be reported.
次要结局
- Assess maximum observed drug concentration (Cmax)(Up to 14 days after last dose in each cohort)
- Assess time to maximum concentration (Tmax)(Up to 14 days after last dose in each cohort)
- Assess the area under the concentration-time curve from time 0 to infinity (AUCinf)(Up to 14 days after last dose in each cohort)
- Assess the area under the concentration curve from time 0 to the last quantifiable concentration (AUClast)(Up to 14 days after last dose in each cohort)
- Assess half-life (t½) plasma concentration(Up to 14 days after last dose in each cohort)
- Serum fructosamine levels(Up to 14 days after last dose in each cohort)
- Insulin levels(Up to 14 days after last dose in each cohort)
- C-peptide levels(Up to 14 days after last dose in each cohort)
- Glucagon levels(Up to 14 days after last dose in each cohort])