Single-ascending Dose Study of HEC-151 Injection

An I-phase Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics of a Single Dose of HEC-151 Injection in Healthy Chinese Participants in a Single-center, Randomized, Placebo (Single-blind) and Positive Control (Open-label) Study

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Adult Male
• Intervention / Treatment: Drug: Degludec insulin; Drug: HEC-151 Injection; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chengyong Tang, Doctor; Phone Number: +8618983286980; Email: 17235387@qq.com

Study Locations

• China
  • Bishan
    • Chongqing, Bishan, China, 402760
      • Recruiting
      • No. 9, Shuangxing Avenue,, Bishan
      • Contact: Chengyong Tang, Doctor; Phone Number: 8618983286980; Email: 17235387@qq.com
  • Chongqing Municipality
    • Bishan, Chongqing Municipality, China, 402760
      • Not yet recruiting
      • No. 9, Shuangxing Avenue,
      • Contact: Chengyong Tang, Doctor; Phone Number: +8618983286980; Email: 17235387@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Insulin Degludec; The participants received an abdominal subcutaneous injection of Insulin Degludec in the morning of Day 1.	Drug: Degludec insulin; Subcutaneous injection in the abdominal area
Experimental: HEC-151 Injection; The participants received an abdominal subcutaneous HEC-151 Injection in the morning of Day 1.	Drug: HEC-151 Injection; Subcutaneous injection in the abdominal area
Placebo Comparator: Placebo; The participants received an abdominal subcutaneous Injection of placebo in the morning of Day 1.	Drug: Placebo; Subcutaneous injection in the abdominal area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	Frequency, type and severity of adverse events/serious adverse events.	From Day1 to Day36
Electrocardiogram parameter（Heart rate）	Evaluation the heart rate of electrocardiogram parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.	From Day1 to Day36
Electrocardiogram parameter（PR interval）	Evaluation the PR interval of electrocardiogram parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.	From Day1 to Day36
Electrocardiogram parameter（QTcF interval）	Evaluation the QTcF interval of electrocardiogram parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.	From Day1 to Day36
Electrocardiogram parameter(QRS interval)	Evaluation the QRS interval of electrocardiogram parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.	From Day1 to Day36
Vital signs parameter（Body temperature）	Evaluation the body temperature of vital signs parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.	From Day1 to Day36
Vital signs parameter（Blood pressure）	Evaluation the blood pressure of vital signs parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.	From Day1 to Day36
Vital signs parameter（Pulse）	Evaluation the pulse of vital signs parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.	From Day1 to Day36
Vital signs parameter（Respiration）	Evaluation the respiration of vital signs parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.	From Day1 to Day36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.	From Day1 to Day36
AUC0-t	Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.	From Day1 to Day36
Tmax	Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.	From Day1 to Day36
T1/2	Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.	From Day1 to Day36
CL/F	Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.	From Day1 to Day36
GIRmax	Evaluate the Pharmacodynamics effects of HEC-151 Injection in healthy participants.	From Day1 to Day36
tGIRmax	Evaluate the Pharmacodynamics effects of HEC-151 Injection in healthy participants.	From Day1 to Day36
AUCGIR	Evaluate the Pharmacodynamics effects of HEC-151 Injection in healthy participants.	From Day1 to Day36
ADA（Anti-Drug Antibody）	Evaluate the Immunogenic characteristics of HEC-151 Injection in healthy participants.	From Day1 to Day36

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): September 27, 2026

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: HEC-151 Injection
• Additional Relevant MeSH Terms: insulin degludec
• Other Study ID Numbers: HEC-151-DM-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No