Single-ascending Dose Study of HEC-151 Injection

NCT07376200 | Recruiting Phase 1

• 1 other identifier: HEC-151-DM-101
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy Adult Male

Keywords

HEC-151 Injection

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (9)

• Cmax

  From Day1 to Day36

• AUC0-t

  From Day1 to Day36

• Tmax

  From Day1 to Day36

• T1/2

  From Day1 to Day36

• CL/F

  From Day1 to Day36

Study Arms (3)

HEC-151 Injection

EXPERIMENTAL

The participants received an abdominal subcutaneous HEC-151 Injection in the morning of Day 1.

Drug: HEC-151 Injection

Insulin Degludec

ACTIVE COMPARATOR

The participants received an abdominal subcutaneous injection of Insulin Degludec in the morning of Day 1.

Drug: Degludec insulin

Placebo

PLACEBO COMPARATOR

The participants received an abdominal subcutaneous Injection of placebo in the morning of Day 1.

Drug: Placebo

Interventions

Degludec insulin DRUG

Subcutaneous injection in the abdominal area

Insulin Degludec

HEC-151 Injection DRUG

Subcutaneous injection in the abdominal area

HEC-151 Injection

Placebo DRUG

Subcutaneous injection in the abdominal area

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily participate in the trial and sign the informed consent form, understanding and abiding by the research procedures;
• When signing the informed consent form, men aged 18-45 years old (including the boundary value) are eligible;
• 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;
• Normal glucose tolerance \[3.9 mmol/L \< fasting blood glucose (FPG) \< 6.1 mmol/L, and 2-hour post-glucose tolerance test (OGTT) blood glucose after sugar intake \< 7.8 mmol/L\];
• Normal results of insulin release test (IRT), or abnormal results but judged by the researcher to have no clinical significance;
• Glycated hemoglobin (HbA1c) \< 5.7%;
• 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.

You may not qualify if:

• 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;
• Participants who have a known severe allergic history or are allergic to the test drugs and any of their components;
• Participants who had severe trauma or undergone surgery within 90 days before the screening, or plan to undergo major surgery during the study;
• 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);
• 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;
• Participants who have acute diseases or concurrent medication use from the signing of the informed consent form to the first administration of the drug;
• 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;
• 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;
• Participants who have a history of drug abuse or drug use, or whose urine drug screening is positive before the screening;
• 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;
• 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;
• Participants who have received any vaccine within 30 days before the screening, or plan to receive any type of vaccine during the study;
• 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;
• 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;
• 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;

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (2)

No. 9, Shuangxing Avenue,, Bishan

Chongqing, Bishan, 402760, China

RECRUITING

No. 9, Shuangxing Avenue,

Bishan, Chongqing Municipality, 402760, China

NOT YET RECRUITING

MeSH Terms

Interventions

insulin degludec

Central Study Contacts

Chengyong Tang, Doctor

CONTACT

+8618983286980; 17235387@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: HEC-151 Injection, Insulin Degludec, placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 29, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): September 27, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)