Actively Recruiting
Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of a Single Dose of HEC-151 Injection Compared to Insulin Degludec and Placebo in Healthy Adult Males
Led by Sunshine Lake Pharma Co., Ltd. · Updated on 2026-04-29
81
Participants Needed
2
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and how the body absorbs and reacts to a single dose of HEC-151 Injection in healthy adult male volunteers. This Phase 1 clinical trial also evaluates immune response to the injection and compares it with insulin degludec and a placebo. The study is designed to understand the drug's effects in detail before further development. Participants receive one subcutaneous injection in the abdominal area on the morning of Day 1. Individuals are randomly assigned to receive either HEC-151 Injection, insulin degludec as an active comparator, or a placebo injection. The study is single-blind with placebo control and includes a positive control group. The treatment phase is followed by monitoring for safety and drug effects up to Day 36. During the trial, participants undergo regular assessments including monitoring for adverse events, vital signs like heart rate and blood pressure, and electrocardiogram parameters from Day 1 to Day 36. Blood samples are collected to measure drug concentration, metabolic effects, and immune response. Participants are observed closely for any side effects and overall tolerability throughout the study period, which lasts about five weeks.
CONDITIONS
Brief Title
Single-ascending Dose Study of HEC-151 Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male aged 18 to 45 years
- Body weight at least 50 kg
- Body mass index (BMI) between 19.0 and 24.0 kg/m2
- Normal glucose tolerance with fasting blood glucose between 3.9 and 6.1 mmol/L and 2-hour post-glucose less than 7.8 mmol/L
- Normal or clinically insignificant insulin release test results
- Glycated hemoglobin (HbA1c) less than 5.7%
- No plans for reproduction, sperm collection, or donation during the study and willing to use effective contraception until 3 months after dosing
You will not qualify if you...
- Significant medical or surgical history or current significant disease affecting drug metabolism
- Known severe allergies to study drugs or components
- Severe trauma or surgery within 90 days before screening or planned major surgery during study
- History of hypo- or hyperglycemia within 90 days or family history of diabetes in first-degree relatives
- Blood donation or significant blood loss (≥400 mL) within 90 days or planned blood donation during study
- Acute diseases or medication use from consent to first drug administration
- Abnormal vital signs, physical exam, lab tests, ECG, or chest X-ray with clinical significance
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- History or positive screening for drug abuse
- Use of prescription, herbal, OTC drugs, or supplements (except vitamins/calcium) within 30 days
- Participation in other clinical drug/device research within 90 days
- Vaccine use within 30 days before screening or planned during study
- Smoking more than 5 cigarettes per day within 90 days or inability to comply with smoking restrictions
- Excessive alcohol use or positive breath test or inability to comply with alcohol restrictions
- Excessive caffeine or related products consumption within 90 days or during study
- Use of special or xanthine diets affecting drug metabolism or inability to comply with dietary restrictions
- Significant changes in diet or exercise within 90 days or inability to maintain stable habits
- Difficulty with venous blood collection or history of fainting/hematemesis
- Any other factors judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 days
Participants receive a single abdominal subcutaneous injection of either HEC-151 Injection, Insulin Degludec, or placebo on the morning of Day 1.
1 baseline visit and multiple follow-up visits through Day 36
Trial Site Locations
Total: 2 locations
1
No. 9, Shuangxing Avenue,, Bishan
Chongqing, Bishan, China, 402760
Actively Recruiting
2
No. 9, Shuangxing Avenue,
Bishan, Chongqing Municipality, China, 402760
Not Yet Recruiting
Research Team
C
Chengyong Tang, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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