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

NCT06577428 | Completed Phase 1

• 1 other identifier: RAY1225-24-05
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of RAY1225 From Time Zero to Infinity (AUC[0-∞])

  DAY1~43

• PK: Maximum Concentration (Cmax) of RAY1225

  DAY1~43

Secondary Outcomes (1)

• Number of participants with adverse events

  DAY1~43

Study Arms (3)

RAY1225 - Upper Arm

EXPERIMENTAL

Participants received 3mg RAY1225 by subcutaneous injection on upper arm.

Drug: RAY1225

RAY1225 - Thigh

EXPERIMENTAL

Participants received 3mg RAY1225 by subcutaneous injection on thigh.

Drug: RAY1225

RAY1225 - Abdomen

EXPERIMENTAL

Participants received 3mg RAY1225 by subcutaneous injection on abdomen.

Drug: RAY1225

Interventions

RAY1225 DRUG

administered SC

RAY1225 - Abdomen; RAY1225 - Thigh; RAY1225 - Upper Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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);
• Ability to understand and willingness to sign a written informed consent form;
• Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

You may not qualify if:

• 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;
• Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 days prior to screening；
• 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;
• Participants who donated blood/bleeding profusely (\> 400 mL) 3 months prior to randomization;
• Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF \> 450ms;
• 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);
• Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
• Females who are pregnant, lactating, or likely to become pregnant during the study.
• History of dysphagia or any gastrointestinal disorder that affect absorption;
• Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Guangdong Hospital of Chinese Medicine

Guanzhou, Guangdong, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: July 30, 2024
• Primary Completion: September 29, 2024
• Study Completion: October 8, 2024
• Last Updated: March 19, 2025

Record last verified: 2024-08

Locations

CN (1)