Clinical trial NCT03745885: A Study of the Efficacy and Safety of Supaglutide in Healthy Participants
Official title: A Randomized, Double-blind, Placebo-controlled Study the Efficacy and Safety of Supaglutide in Chinese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Sponsor class: OTHER
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2018-11-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Pharmacokinetic：Cmax of Supaglutide
timeFrame: baseline and up to 29 days after formal dose
measure: Pharmacokinetic: Tmax of Supaglutide
timeFrame: baseline and up to 29 days after formal dose
measure: Pharmacokinetic: AUC0-t of Supaglutide
timeFrame: baseline and up to 29 days after formal dose
measure: Pharmacokinetic: t½ of Supaglutide
timeFrame: baseline and up to 29 days after formal dose
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References: