A Study of the Efficacy and Safety of Supaglutide in Healthy Participants

NCT ID: NCT03745885

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-04
• Study Completion Date: 2019-12-13

Brief Summary

This study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug Supaglutide proposed dosing once (or twice) weekly in Chinese healthy subjects.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.15mg Supaglutide or placebo

0.15 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously（SC） to healthy participants

Group Type: EXPERIMENTAL

Supaglutide injection

Intervention Type: DRUG

Administered SC in the Supaglutide arms.

Placebo

Intervention Type: DRUG

Administered SC in the placebo arms and to maintain the blind in the Supaglutide injection arms.

0.375mg Supaglutide or placebo

0.375 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously（SC） to healthy participants

Group Type: EXPERIMENTAL

Supaglutide injection

Intervention Type: DRUG

Administered SC in the Supaglutide arms.

Placebo

Intervention Type: DRUG

Administered SC in the placebo arms and to maintain the blind in the Supaglutide injection arms.

0.75mg Supaglutide or placebo

0.75 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously（SC） to healthy participants

Group Type: EXPERIMENTAL

Supaglutide injection

Intervention Type: DRUG

Administered SC in the Supaglutide arms.

Placebo

Intervention Type: DRUG

Administered SC in the placebo arms and to maintain the blind in the Supaglutide injection arms.

1.5mg Supaglutide or placebo

1.5 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously（SC） to healthy participants

Group Type: EXPERIMENTAL

Supaglutide injection

Intervention Type: DRUG

Administered SC in the Supaglutide arms.

Placebo

Intervention Type: DRUG

Administered SC in the placebo arms and to maintain the blind in the Supaglutide injection arms.

3.0mg Supaglutide or placebo

3.0 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously（SC） to healthy participants

Group Type: EXPERIMENTAL

Supaglutide injection

Intervention Type: DRUG

Administered SC in the Supaglutide arms.

Placebo

Intervention Type: DRUG

Administered SC in the placebo arms and to maintain the blind in the Supaglutide injection arms.

Interventions

Supaglutide injection

Administered SC in the Supaglutide arms.

Intervention Type: DRUG

Placebo

Administered SC in the placebo arms and to maintain the blind in the Supaglutide injection arms.

Intervention Type: DRUG

Other Intervention Names

Diabegone

Eligibility Criteria

Inclusion Criteria

1. Healthy subjects between 18 and 45 years old（inclusive）.

2. Body mass index（BMI）is between 18 and 28 kg/m2 (inclusive). The weight of male subjects should not be less than 50 kg, and female subjects should not be less than 45 kg.

3. The female participant with reproductive potential, will be required a negative pregnancy test before trial, maintaining non-pregnancy during the whole study period and contraception 3 months after formal injection.

4. Participants must sign the informed consent.

Exclusion Criteria

1. Have a history of allergic reaction or hypersensitivity to the study drugs, or who develop allergic reaction.

2. Have an evidence of Fasting blood-glucose greater than (>) 6.0 mmol/L or less than (<) 3.9 mmol/L, or hemoglobin A1c (HbA1c) greater than or equal to (>=) 6.5 percent (%);

3. Have evidence of Sitting Blood ( take a break for five minutes) , systolic pressure exceeds the range of 90 to 140 mmHg, or diastolic pressure exceeds the range of 50 to 90 mmHg, or Heart Rate exceeds the range of 50 bpm to100 bpm (including critical value)

4. Have an evidence of ECG abnormalities including QTc >450 msec or QRS complex >120 msec. If QT Corrected >450 msec; or QRS >120msec, subject should Repeat the ECG measurements twice and use the average of the QTc or QRS values measured to determine whether the subjects are eligible.

5. Have an evidence of physical examination, vital sign, laboratory examination or electrocardiographic examination that investigator think can affect this trial;

6. Have an individual or a family history of thyroid C-cell tumors/ carcinoma or with a history of thyroid dysfunction, thyroid hormone abnormalities or thyroid-related hormones exceeded the normal range;

7. Have a history of significant illness or medical disorders, including acute or chronic pancreatitis, cardiovascular disease, renal disorder, hematological disease，hepatic or gastrointestinal disease, neurological or psychiatric disease, metabolic disorder, or other diseases that may affect the absorption, distribution, metabolism or excretion of drugs, such as active gastrointestinal ulcers or bleeding, gastrointestinal surgery(except appendectomy).

8. Have a history of major surgery within 4 weeks or major minor surgery during the whole study period;

9. Have a history of smoking or the use of nicotine products or electronic cigarettes, abusing alcohol or abusing drug within 3 months;

10. Have a presence of prescription or non-prescription drugs, including Chinese Traditional and Herbal Drugs within 2 weeks; Previous use of glucagon-like peptide-1 analogue or another intestinal insulin, or any unknown cause of infections.

11. Have a presence of any food or drink containing caffeine or xanthine within 48 hours before administration.

12. Have a history of a New Chemical Entity clinical study within the previous 3 months.

13. Have a presence of pregnancy or lactation.

14. Have a presence of positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV), or human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody.

15. Have a history of blood donation or loss more than 400 ml (including in the frame of a clinical study) within 3 months before administration;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: collaborator

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Countries

China

References

Lou YR, Xu YL, Xiong Y, Deng C, Wang Q. Population Pharmacokinetics of Efsubaglutide Alfa in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2025 Apr;64(4):533-552. doi: 10.1007/s40262-025-01475-7. Epub 2025 Feb 17.

Reference Type: DERIVED

PMID: 39961992 (View on PubMed)

Other Identifiers

YN011A

Identifier Type: -

Identifier Source: org_study_id