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Clinical Trials in China / NCT07376200
Recruiting Phase 1

Single-ascending Dose Study of HEC-151 Injection

NCT07376200 · tracked via the Priya Life Science China tracker
Sponsor
Sunshine Lake Pharma Co., Ltd.
Phase
Phase 1
Started
2026-02-24
Last updated
2026-04-29

Condition(s) studied

Healthy Adult Male

Investigational drug(s) / intervention(s)

HEC-151 InjectionDegludec insulinPlacebo

HEC-151 Injection: Subcutaneous injection in the abdominal area

Degludec insulin: Subcutaneous injection in the abdominal area

Placebo: Subcutaneous injection in the abdominal area

Study summary

Evaluate the safety, tolerability, PK/PD and immunogenicity characteristics of a single subcutaneous HEC-151 Injection solution in healthy participants

Eligibility

Sex
MALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Voluntarily participate in the trial and sign the informed consent form, understanding and abiding by the research procedures; 2. When signing the informed consent form, men aged 18-45 years old (including the boundary value) are eligible; 3. During the screening process, male subjects with a body weight of ≥ 50 kg and a body mass index (BMI) of ≥ 19.0 and ≤ 24.0 kg/m2 are included; 4. Normal glucose tolerance \[3.9 mmol/L \< fasting blood glucose (FPG) \< 6.1 mmol/L, and 2-hour post-glucose tolerance test (OGTT) blood glucose after sugar intake \< 7.8 mmol/L\]; 5. Normal results of insulin release test (IRT), or abnormal results but judged by the researcher to have no clinical significance; 6. Glycated hemoglobin (HbA1c) \< 5.7%; 7. During the study period, there are no plans for reproduction, sperm collection, or sperm donation, and are willing to take effective contraceptive measures throughout the study period until 3 months after the administration of the investigational drug. Exclusion Criteria: 1. Participants with abnormal medical histories or surgical histories judged clinically significant by the researchers, or currently suffering from any diseases in the endocrine system, blood system, cardiovascular system, respiratory system, digestive system, urinary system, immune system, nervous system, etc. that are judged clinically significant by the researchers, or any other diseases or physiological conditions that can significantly affect the absorption, distribution, metabolism or excretion of the drugs; 2. Participants who have a known severe allergic history or are allergic to the test drugs and any of their components; 3. Participants who had severe trauma or undergone surgery within 90 days before the screening, or plan to undergo major surgery during the study; 4. Participants who have a history of hypoglycemia or hyperglycemia within 90 days before the screening, or have a family history of diabetes (first-degree direct relatives); 5. Participants who have donated blood or suffered significant blood loss (≥ 400 mL) within 90 days before the screening, or plan to donate blood during the study; 6. Participants who have acute diseases or concurrent medication use from the signing of the informed consent form to the first administration of the drug; 7. Participants whose vital signs, physical examination, laboratory tests, electrocardiogram, chest X-ray examination, etc. results are abnormal and judged by the researchers to have clinical significance; 8. Participants whose test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), combined human immunodeficiency virus antigen antibody (HIV), or syphilis spirochete antibody (TP) are positive; 9. Participants who have a history of drug abuse or drug use, or whose urine drug screening is positive before the screening; 10. Participants who have used any prescription drugs, Chinese herbal medicines, over-the-counter drugs, health supplements (except for regular supplementary vitamins and calcium) within 30 days before the screening; 11. Participants who have participated in any clinical research of drugs or devices (defined as receiving the test drugs or devices) within 90 days before the screening; 12. Participants who have received any vaccine within 30 days before the screening, or plan to receive any type of vaccine during the study; 13. Participants who smoke more than 5 cigarettes per day within 90 days before the screening, or cannot comply with the smoking prohibition rule during the study; 14. Participants who frequently drink alcohol, that is, consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), or have a positive alcohol breath test; or who cannot comply with the alcohol prohibition rule during the study; 15. Participants who consume excessive tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup ≈ 250 mL) or food (such as chocolate) every day within 90 days before the screening, or during the study; 16. Participants who have used special diets (including dragon fruit, mango, pomelo, etc.) and/or xanthine diet (salmon, sardines, liver, kidney, etc.) or have other factors affecting drug absorption, distribution, metabolism, and excretion before the signing of the informed consent form to the use of the test drugs, or who cannot comply with the prohibition of eating during the study; 17. Participants who have had significant changes in diet or exercise habits within 90 days before the screening, or have engaged in intense exercise before the signing of the informed consent form to the use of the test drugs, or cannot stop during the study; 18. Participants who have difficulty in venous blood collection, or cannot tolerate venipuncture, or have a history of fainting or hematemesis; 19. Participants who, in the researcher's opinion, have other factors that are not suitable for participating in this study.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
No. 9, Shuangxing Avenue,, Bishan Chongqing Bishan Recruiting
No. 9, Shuangxing Avenue, Bishan Chongqing Municipality Not Yet Recruiting

More Sunshine Lake Pharma Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07376200 on ClinicalTrials.gov ↗ ← All trials in China