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CompletedNCT06577428Updated Mar 19, 2025

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

A Phase 1 interventional study of RAY1225 in Healthy, sponsored by Guangdong Raynovent Biotech Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by Guangdong Raynovent Biotech Co., Ltd · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd is the lead sponsor of 35 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    RAY1225 - Upper Arm

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

    Drug: RAY1225

  • Experimental
    RAY1225 - Thigh

    Participants received 3mg RAY1225 by subcutaneous injection on thigh.

    Drug: RAY1225

  • Experimental
    RAY1225 - Abdomen

    Participants received 3mg RAY1225 by subcutaneous injection on abdomen.

    Drug: RAY1225

Interventions

  • DrugRAY1225

    administered SC

06

What researchers measure

Primary outcomes

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

    Time frame: DAY1~43

  2. PK: Maximum Concentration (Cmax) of RAY1225

    Time frame: DAY1~43

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: DAY1~43

07

Study locations

1 site
  • Guangdong Hospital of Chinese Medicine
    Guanzhou, Guangdong, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06577428
Lead sponsor
Guangdong Raynovent Biotech Co., Ltd
Responsible party
Sponsor
First posted
Aug 29, 2024
Start date
Jul 30, 2024
Primary completion
Sep 29, 2024
Completion
Oct 8, 2024
Last update
Mar 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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