临床试验/NCT05835752

NCT05835752

已完成

1 期

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RAY1225

Guangdong Raynovent Biotech Co., Ltd1 个研究点分布在 1 个国家目标入组 68 人2023年5月18日

适应症Obese Healthy

干预措施RAY1225 Placebo

概览

阶段: 1 期
干预措施: RAY1225
疾病 / 适应症: Obese
发起方: Guangdong Raynovent Biotech Co., Ltd
入组人数: 68
试验地点: 1
主要终点: Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)
状态: 已完成
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This trial is conducted in China. The aim of the trial is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of RAY1225

注册库

clinicaltrials.gov

开始日期

2023年5月18日

结束日期

2024年3月23日

最后更新

上个月

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Guangdong Raynovent Biotech Co., Ltd

责任方

Sponsor

入排标准

入选标准

•Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
•Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
•Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
•Body weight is no less than 50 kg in males and no less than 45 kg in females. Body mass index (BMI) 18≤BMI\<28 kg/m2（Part A\&B only);BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
•BMI≥28 kg/m2（Part C only）.BMI is determined by the following equation: BMI = weight/height2 (kg/m2).

排除标准

•Participants with clinically significant disorders (including but not limited to, cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immune, neurological, psychiatric, cutaneous, hematological disorders, retinopathy, and neoplasms etc. )within 24 weeks prior to randomization.
•Participants who are not suitable for subcutaneous injections (trauma, surgery, allergies or skin lesions, etc.).
•Known history of definite mental illness, such as depression, suicidal ideation, schizophrenia, bipolar disorder.
•Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2 or with thyroid nodules of unknown etiology found at screening and considered clinically significant by the investigator.
•Participants who experienced a grade 3 hypoglycemic event within the 12 months prior to randomization, or experienced a hypoglycemic event (venous or terminal blood glucose \<3 mmol/L ) ≥3 times or with hypoglycemia-related symptoms within 3 months prior to randomization.
•Participants with clinically significant abnormalities on ECG, or QTcF \>450ms, or with a family history of long QT syndrome or a family history of Brugada syndrome.
•Participants who planning to use glucagon-like peptide-1 (GLP-1) receptor agonists and GLP1-related drugs or other enteroglucagon peptides(including but not limited to: exenatide, liraglutide, lisnatide, benalutide, dulaglutide, lorcetide, semaglutide, tirzepatide), during the 12 weeks prior to randomization or during the trial.
•Participants who undergone major surgery, donated blood/bleeding profusely (\> 400 mL) 12 weeks prior to randomization, donated blood/bleeding profusely (\>200 mL) 4 weeks prior to randomization,or have a serious infection.
•The average daily smoking are more than 5 cigarettes within 12 weeks prior to screening or unwilling to quit smoking during the study period.
•Participants who may not complete the study for other reasons or should not be included in the study in the opinion of the investigator.

研究组 & 干预措施

RAY1225(Part A)

Escalating doses of RAY1225 administered subcutaneously (SC) once in healthy participants.

干预措施: RAY1225

Placebo (Part A)

Placebo administered SC once in healthy participants.

干预措施: Placebo

RAY1225 (Part B)

Escalating doses RAY1225 administered SC once weekly for four weeks in healthy participants.

干预措施: RAY1225

Placebo (Part B)

Placebo administered SC once weekly for four weeks in healthy participants.

干预措施: Placebo

RAY1225(Part C)

Three dose levels of RAY1225 administered SC once weekly for four weeks in participants with Obese.

干预措施: RAY1225

Placebo (Part C)

Placebo administered SC once weekly for four weeks in participants with Obese.

干预措施: Placebo

结局指标

主要结局

Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)

时间窗: Baseline through Day 29 (Part A)

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported

Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)

时间窗: Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C)

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported

次要结局

To determine the single oral dose pharmacokinetic profiles of RAY1225(AUC0-∞)(Baseline through Day 29 (Part A))
To determine the Pharmacodynamics of RAY1225（Change in Waist circumference）(Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C))
To determine the multiple oral dose pharmacokinetic profiles of RAY1225(AUC0-∞)(Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C))
To determine the Pharmacodynamics of RAY1225(Change in Body Weight）(Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C))