A Study of RAY1225 at Different Injection Sites in Participants With Different Body Sizes

March 18, 2025 updated by: Guangdong Raynovent Biotech Co., Ltd

Effect of Injection Site on the Relative Bioavailability of a Single Dose of RAY1225 in Subjects With Low and High Body Mass Index

The purpose of this study is to compare the amount of RAY1225 that gets into the blood stream and how long it takes the body to get rid of it, when injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of RAY1225 will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 7 weeks, including screening.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guanzhou, Guangdong, China
        • Guangdong Hospital of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Body mass index (BMI) ≥19 kg/m2 and total body weight >50 kg for male, >45 kg for female at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
  2. Ability to understand and willingness to sign a written informed consent form;
  3. Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion Criteria:

  1. Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product;
  2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 days prior to screening；
  3. Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
  4. Participants who donated blood/bleeding profusely (> 400 mL) 3 months prior to randomization;
  5. Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF > 450ms;
  6. Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
  7. Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
  8. Females who are pregnant, lactating, or likely to become pregnant during the study.
  9. History of dysphagia or any gastrointestinal disorder that affect absorption;
  10. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAY1225 - Upper Arm
Participants received 3mg RAY1225 by subcutaneous injection on upper arm.
Drug: RAY1225
administered SC
Experimental: RAY1225 - Thigh
Participants received 3mg RAY1225 by subcutaneous injection on thigh.
Drug: RAY1225
administered SC
Experimental: RAY1225 - Abdomen
Participants received 3mg RAY1225 by subcutaneous injection on abdomen.
Drug: RAY1225
administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of RAY1225 From Time Zero to Infinity (AUC[0-∞])
Time Frame: DAY1~43
DAY1~43
PK: Maximum Concentration (Cmax) of RAY1225
Time Frame: DAY1~43
DAY1~43

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: DAY1~43
DAY1~43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Raynovent Biotech Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2024

Primary Completion (Actual)

September 29, 2024

Study Completion (Actual)

October 8, 2024

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • RAY1225-24-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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