A Phase 1, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of AGMB-129 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of participant with Adverse Events
研究概览
简要总结
In patients with Crohn's disease (CD), fibrosis of the gastrointestinal (GI) tract can result in stricture (stenosis) formation and obstruction of the GI tract, causing obstructive symptoms and often requiring surgical intervention. There are currently no approved therapies for treating fibrostenotic Crohn's disease (FSCD) and therefore, there is an urgent need for safe and effective antifibrotic therapies.
AGMB-129 has shown to be safe in healthy participants with single doses up to 1200 mg and multiple doses up to 200 mg twice daily (BID) for 10 days, and in FSCD patients with multiple doses up to 200 mg BID for 12 weeks.
This Phase 1 study will explore the safety, tolerability, and pharmacokinetics (PK) of other daily doses of AGMB-129 in healthy participants to inform on dose selection (nominal dose and dosing frequency) for subsequent clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participants, investigator(s), blinded monitors, and employees of the site involved in the management of the study will be blinded to intervention, unless in case of emergency.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 55 years of age (extremes included), at the time of signing the informed consent.
- •Body weight of at least 50.0 kg for men and 45.0 kg for women, and a BMI between 19.0 and 30.0 kg/m2 (extremes included) at screening.
- •Male or female
排除标准
- •Known hypersensitivity to AGMB-129 ingredients or history of a significant allergic reaction to AGMB-129 ingredients as determined by the investigator.
- •Positive serology for HBsAg or anti-HCV antibodies at screening, or history of hepatitis from any cause except for hepatitis A that was resolved at least 3 months prior to the first administration of study treatment.
- •History of or a current immunosuppressive condition, including a positive test for HIV-1 or HIV-2 antibodies at screening.
- •Presence or sequelae of gastrointestinal, liver, kidney (eGFR ≤80 mL/min/1.73 m² using the CKD-EPI formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs at screening. Note: Participants who have an eGFR of up to 10% below 80 mL/min/1.73 m2 may be enrolled in the study at the discretion of the investigator.
研究组 & 干预措施
AGMB-129
participants will receive a single dose of AGMB-129 (reference cohort) for 7 consecutive days or multiple doses of AGMB-129 (cohort 1, 2, 3) for 7 consecutive days
干预措施: AGMB-129 (Drug)
Placebo
participants will receive a single dose of placebo (reference cohort) for 7 consecutive days or multiple doses of placebo (cohort 1, 2, 3) for 7 consecutive days
干预措施: Placebo (Other)
结局指标
主要结局
Number of participant with Adverse Events
时间窗: From enrollment to the end of treatment at 42 days
To evaluate the safety and tolerability of AGMB-129 in terms of adverse events (AE) at every visit
Number of participant with abnormal Physical examination
时间窗: From enrollment to the end of treatment at 42 days
To evaluate the safety and tolerability of AGMB-129 in terms of physical examination at every visit
Number of participant with abnormal Vital signs
时间窗: From enrollment to the end of treatment at 42 days
To evaluate the safety and tolerability of AGMB-129 in terms of vital signs
Number of participant with abnormal electrocardiograms (ECGs) parameters
时间窗: From enrollment to the end of treatment at 42 days
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal electrocardiograms (ECGs) at every visit
Number of participant with abnormal 2-dimensional (2-D) echocardiography
时间窗: From enrollment to the end of treatment at 42 days
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal 2-dimensional (2-D) echocardiography at every visit
Number of participant with abnormal clinical laboratory tests
时间窗: From enrollment to the end of treatment at 42 days
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal clinical laboratory parameters at every visit
次要结局
- Plasma levels of AGMB-129(From enrollment to the end of treatment at 42 days)
- Plasma levels of metabolite MET-154(From enrollment to the end of treatment at 42 days)
- Plasma levels of metabolite MET-158(From enrollment to the end of treatment at 42 days)