NCT07673900招募中1 期
A Randomized, Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Epi/Intra-dermally Administered Semaglutide (VX-201) Compared to Subcutaneous Administration in Healthy Overweight and Obese Participants: Single and Multiple Dose Assessment
Terrestrial Bio, Inc.1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2026年6月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Type, incidence, and severity of treatment emergent adverse events (TEAEs), including assessment of application site skin sensitivity, vital signs, electrocardiograms (ECGs), and clinical laboratory results)
研究概览
简要总结
VX-201-101 is a first-in-human Phase 1 clinical study evaluating VX-201, a needle-free microneedle (MN) array patch (MAP) that delivers semaglutide through the skin as an alternative to subcutaneous (SC) injection.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for study participation, all subjects must meet all the following inclusion criteria:
- •Medically healthy with no clinically significant medical history, vital sign, or coagulation results at Screening; chemistry, hematology, or urinalysis at Screening and Day -1 (SAD)/Day 0 (MD) as deemed by the Investigator
- •Age 18 to 60 years, inclusive, at the time of Screening
- •Body mass index ≥25 to <35 kg/m2 if participating in the SAD phase or ≥27 to <40 kg/m2 if participating in the MD phase, at the time of Screening
- •Must be able to communicate well with the Investigator, understand and comply with the requirements of the study (including required confinement periods), and understand and provide written consent
排除标准
- •All subjects meeting any of the following criteria will be excluded from this study:
- •Any disorder which in the investigator's opinion might jeopardize the subject's safety, evaluation of results, or compliance with the protocol
- •Any of the following obesity or glycemia-related history:
- •Treatment with a GLP-1 receptor agonist within 90 days before screening
- •Treatment with any medication for the indication of obesity within the past 90 days before screening
- •A self-reported change in body weight > 5 kg (11 lb) within 90 days before screening irrespective of medical records.
- •Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device
- •HbA1c ≥ 6.5% as measured at screening
- •History of type 1 or type 2 diabetes mellitus
- •Have a history of heart block, or a pulse rate (PR) interval >200 milliseconds (msec), or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
- •Have a significant history of or current cardiovascular (myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study medication, or interfering with the interpretation of data
- •Estimated glomerular filtration rate <80 mL/min as determined by the Mosteller body surface area correction equation at Screening
- •Have a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- •Presence of acute pancreatitis within the past 90 days prior to the day of screening or history or presence of chronic pancreatitis
- •Active malignancy or history of malignancy of any organ system (other than localized squamous cell or basal cell carcinoma of the skin that have been excised or resolved), treated or untreated, within the past 5 years
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method
- •Any prescription medications (except for hormonal contraception associated with inhibition of ovulation as described Exclusion 9) within 14 days of Screening
- •Previously participated in another dose level group in the study
- •Known hypersensitivity to semaglutide
- •Known or suspected alcohol or drugs/chemical substance abuse within one year prior to the day of screening, or positive drug or alcohol screen results at Screening or Day-1
- •Positive result for human immunodeficiency virus (HIV) or presence of actively replicating viral hepatitis due to hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at Screening
- •Excessive tattoos, skin blemishes, or excessive hair near patch administration site
- •Participation in any clinical study with an investigational or approved drug/device within 30 days or 5 half-lives (whichever is longer) before Screening or is planning to participate in another clinical study while enrolled in this study
- •Donated or lost >200 mL of blood within 60 days before Day -1, donated plasma within 7 days before Day -1, or plans to donate blood or plasma during the study
- •Is directly affiliated with the study at the study site or is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the study site, or is employed by Terrestrial Bio (that is an employee, temporary contract worker, or designee responsible for the conduct of the study) or is an immediate family member of an employee of Terrestrial Bio
研究组 & 干预措施
Single 0.25 mg semaglutide SC dose
Active Comparator
Subjects will receive a single 0.25 mg semaglutide SC dose
干预措施: semaglutide SC (Drug)
Multiple VX-201 1.7 and 2.5 mg dose
Experimental
Subjects will receive four weekly 1.7 mg VX-201 doses followed by four weekly 2.4 mg VX-201 doses
干预措施: VX-201 (Combination Product)
Multiple semaglutide SC 1.7 and 2.5 mg dose
Active Comparator
Subjects will receive four weekly 1.7 mg of semaglutide SC doses followed by four weekly 2.4 mg semaglutide SC doses
干预措施: semaglutide SC (Drug)
Single VX-201 0.5 mg dose
Experimental
Subjects will receive a single 0.5 mg VX-201 dose
干预措施: VX-201 (Combination Product)
Single semaglutide SC 0.5 mg dose
Active Comparator
Subjects will receive a single 0.5 mg semaglutide SC dose
干预措施: semaglutide SC (Drug)
VX-201 0.25 mg SAD Phase
Experimental
Subjects will receive a single 0.25 mg VX-201 dose
干预措施: VX-201 (Combination Product)
结局指标
主要结局
Type, incidence, and severity of treatment emergent adverse events (TEAEs), including assessment of application site skin sensitivity, vital signs, electrocardiograms (ECGs), and clinical laboratory results)
时间窗: From enrollment until approximately 5 weeks after the last dose of study drug
次要结局
未报告次要终点
研究者
研究点 (1)
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