Clinical trial NCT05835752: The Safety, Tolerability and Pharmacokinetic Study of RAY1225
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RAY1225
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obese
Healthy
Keywords: obesity
GLP-1
GIP
Lead sponsor: Guangdong Raynovent Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-04-28
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
3. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
4. 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).
5. BMI≥28 kg/m2（Part C only）.BMI is determined by the following equation: BMI = weight/height2 (kg/m2).

Exclusion Criteria:

1. 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.
2. Participants who are not suitable for subcutaneous injections (trauma, surgery, allergies or skin lesions, etc.).
3. Known history of definite mental illness, such as depression, suicidal ideation, schizophrenia, bipolar disorder.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. The average daily smoking are more than 5 cigarettes within 12 weeks prior to screening or unwilling to quit smoking during the study period.
10. Participants who may not complete the study for other reasons or should not be included in the study in the opinion of the investigator.
11. Known presence of a single genetic mutation, other diseases or medications causing obesity, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, growth hormone deficiency, acromegaly, pseudohypoparathyroidism, hypogonadism, or weight gain caused by increased non-fat content (e.g., edema)\[Part C only\]

Primary outcomes:
measure: Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)
timeFrame: Baseline through Day 29 (Part A)
measure: Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)
timeFrame: Baseline through Day 50 (Part B&C)
Secondary outcomes:
measure: To determine the single oral dose pharmacokinetic profiles of RAY1225(AUC0-∞)
timeFrame: Baseline through Day 29 (Part A)
measure: To determine the multiple oral dose pharmacokinetic profiles of RAY1225(AUC0-∞)
timeFrame: Baseline through Day 50(Part B&C)
measure: To determine the Pharmacodynamics of RAY1225(Change in Body Weight）
timeFrame: Baseline through Day 50(Part C)
measure: To determine the Pharmacodynamics of RAY1225（Change in Waist circumference）
timeFrame: Baseline through Day 50(Part C)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital,South Medical Hospital
state: Guangdong
Study officials:
References: