ClinicalTrials.gg
RecruitingNCT07376200Updated Sep 25, 2026

Single-ascending Dose Study of HEC-151 Injection

A Phase 1 interventional study of HEC-151 Injection and Degludec insulin in Healthy Adult Male, sponsored by Sunshine Lake Pharma Co., Ltd.. Recruiting at 2 sites in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Sunshine Lake Pharma Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Updated Sep 25, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy Adult Male

Keywords

  • HEC-151 Injection
03

In context

Lead sponsor

Sunshine Lake Pharma Co., Ltd. is the lead sponsor of 83 studies on the registry; 13 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntarily participate in the trial and sign the 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 (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. (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 measures throughout the study period until 3 months after the administration of the drug.

Exclusion criteria

Exclusion Criteria:

  1. Participants with abnormal medical histories or surgical histories judged 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 form to the first administration of the drug;
  7. Participants whose vital signs, physical examination, laboratory tests, , chest X-ray examination, etc. results are abnormal and judged by the researchers to have clinical significance;
  8. Participants whose test results for surface antigen (HBsAg), antibody (anti-HCV), combined 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.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
81 participants (estimated)

Study arms

  • Experimental
    HEC-151 Injection

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

    Drug: HEC-151 Injection

  • Active comparator
    Insulin Degludec

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

    Drug: Degludec insulin

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugHEC-151 Injection

    Subcutaneous injection in the abdominal area

  • DrugDegludec insulin

    Subcutaneous injection in the abdominal area

  • DrugPlacebo

    Subcutaneous injection in the abdominal area

06

What researchers measure

Primary outcomes

  1. Adverse event

    Frequency, type and severity of adverse events/serious adverse events.

    Time frame: From Day1 to Day36

  2. 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.

    Time frame: From Day1 to Day36

  3. 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.

    Time frame: From Day1 to Day36

  4. 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.

    Time frame: From Day1 to Day36

  5. 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.

    Time frame: From Day1 to Day36

  6. 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.

    Time frame: From Day1 to Day36

  7. 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.

    Time frame: From Day1 to Day36

  8. 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.

    Time frame: From Day1 to Day36

  9. 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.

    Time frame: From Day1 to Day36

Secondary outcomes

  1. Cmax

    Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.

    Time frame: From Day1 to Day36

  2. AUC0-t

    Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.

    Time frame: From Day1 to Day36

  3. Tmax

    Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.

    Time frame: From Day1 to Day36

  4. T1/2

    Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.

    Time frame: From Day1 to Day36

  5. CL/F

    Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.

    Time frame: From Day1 to Day36

  6. GIRmax

    Evaluate the Pharmacodynamics effects of HEC-151 Injection in healthy participants.

    Time frame: From Day1 to Day36

  7. tGIRmax

    Evaluate the Pharmacodynamics effects of HEC-151 Injection in healthy participants.

    Time frame: From Day1 to Day36

  8. AUCGIR

    Evaluate the Pharmacodynamics effects of HEC-151 Injection in healthy participants.

    Time frame: From Day1 to Day36

  9. ADA(Anti-Drug Antibody)

    Evaluate the Immunogenic characteristics of HEC-151 Injection in healthy participants.

    Time frame: From Day1 to Day36

07

Study locations

1 of 2 sites recruiting
  • No. 9, Shuangxing Avenue,, Bishan
    Chongqing, Bishan 402760, China
    Recruiting
  • No. 9, Shuangxing Avenue,
    Bishan, Chongqing Municipality 402760, China
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Sep 5, 2026→Dec 31, 2026
Sep 25, 2026
Study completion
Sep 27, 2026→Jan 31, 2027
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Primary completion Sep 5, 2026→Dec 31, 2026
    Study completion Sep 27, 2026→Jan 31, 2027

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07376200
Responsible party
Sponsor
First posted
Jan 29, 2026
Start date
Feb 24, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Chengyong Tang, Doctor
Contact
17235387@qq.com
+8618983286980

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion