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Completed

NCT Number: NCT05835752

The Safety, Tolerability and Pharmacokinetic Study of RAY1225

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nanfang Hospital,South Medical Hospital

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.
  • 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]

Treatment and study plan

RAY1225

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

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

    Time frame: Baseline through Day 29 (Part A)

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

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

    Time frame: 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

Secondary outcomes

  1. To determine the single oral dose pharmacokinetic profiles of RAY1225(AUC0-∞)

    Time frame: Baseline through Day 29 (Part A)

  2. To determine the multiple oral dose pharmacokinetic profiles of RAY1225(AUC0-∞)

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

  3. To determine the Pharmacodynamics of RAY1225(Change in Body Weight)

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

  4. To determine the Pharmacodynamics of RAY1225(Change in Waist circumference)

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

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2023
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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