Healthy Adult MalePhase 1NCT07376200
Single-ascending Dose Study of HEC-151 Injection
A Phase 1 study testing HEC-151 Injection and Degludec insulin in people with Healthy Adult Male, run by Sunshine Lake Pharma Co., Ltd. at 2 sites in China.
Trial summary
Evaluate the safety, tolerability, PK/PD and immunogenicity characteristics of a single subcutaneous HEC-151 Injection solution in healthy participants Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- HEC-151 Injection and Degludec insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 2 sitesChina
- Study dates
- 24 Feb 2026to 31 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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;
- 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;
- Participants who have difficulty in venous blood collection, or cannot tolerate venipuncture, or have a history of fainting or hematemesis;
- Participants who, in the researcher's opinion, have other factors that are not suitable for participating in this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
No. 9, Shuangxing Avenue,
Bishan, Chongqing Municipality, 402760
Chengyong Tang, Doctor, +8618983286980, 17235387@qq.com
- Recruiting
No. 9, Shuangxing Avenue,, Bishan
Chongqing, Bishan, 402760
Chengyong Tang, Doctor, 8618983286980, 17235387@qq.com
About this study
Official title: 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
- Conditions
- Healthy Adult Male
- Being tested
- HEC-151 Injection, Degludec insulin, Placebo
- Keywords
- HEC-151 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC-151 InjectionDrug
Subcutaneous injection in the abdominal area
Degludec insulinDrug
Subcutaneous injection in the abdominal area
PlaceboDrug
Subcutaneous injection in the abdominal area
| Study group | Role | What they receive |
|---|---|---|
| HEC-151 Injection | Experimental | The participants received an abdominal subcutaneous HEC-151 Injection in the morning of Day 1. Receives: Drug: HEC-151 Injection |
| Insulin Degludec | Active comparator | The participants received an abdominal subcutaneous injection of Insulin Degludec in the morning of Day 1. Receives: Drug: Degludec insulin |
| Placebo | Placebo comparator | The participants received an abdominal subcutaneous Injection of placebo in the morning of Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Frequency, type and severity of adverse events/serious adverse events.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Day1 to Day36
Secondary outcomes (9)
Cmax
Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.
Measured: From Day1 to Day36
AUC0-t
Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.
Measured: From Day1 to Day36
Tmax
Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.
Measured: From Day1 to Day36
T1/2
Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.
Measured: From Day1 to Day36
CL/F
Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.
Measured: From Day1 to Day36
GIRmax
Evaluate the Pharmacodynamics effects of HEC-151 Injection in healthy participants.
Measured: From Day1 to Day36
tGIRmax
Evaluate the Pharmacodynamics effects of HEC-151 Injection in healthy participants.
Measured: From Day1 to Day36
AUCGIR
Evaluate the Pharmacodynamics effects of HEC-151 Injection in healthy participants.
Measured: From Day1 to Day36
ADA（Anti-Drug Antibody）
Evaluate the Immunogenic characteristics of HEC-151 Injection in healthy participants.
Measured: From Day1 to Day36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start24 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376200
- Sponsor's protocol ID
- HEC-151-DM-101
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07376200
- Acronym / sponsor ID
- HEC-151-DM-101
- Conditions
- Healthy Adult Male
- Keywords
- HEC-151 Injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety, tolerability, PK/PD and immunogenicity characteristics of a single subcutaneous HEC-151 Injection solution in healthy participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HEC-151 Injection | Experimental | Drug: HEC-151 InjectionThe participants received an abdominal subcutaneous HEC-151 Injection in the morning of Day 1. |
| Insulin Degludec | Active comparator | Drug: Degludec insulinThe participants received an abdominal subcutaneous injection of Insulin Degludec in the morning of Day 1. |
| Placebo | Placebo comparator | Drug: PlaceboThe participants received an abdominal subcutaneous Injection of placebo in the morning of Day 1. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEC-151 InjectionSubcutaneous injection in the abdominal area | Drug | HEC-151 Injection |
| Degludec insulinSubcutaneous injection in the abdominal area | Drug | Insulin Degludec |
| PlaceboSubcutaneous injection in the abdominal area | Drug | Placebo |
Primary outcome
Adverse event
Time frame: From Day1 to Day36
Frequency, type and severity of adverse events/serious adverse events.
Electrocardiogram parameter（Heart rate）
Time frame: From Day1 to Day36
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.
Electrocardiogram parameter（PR interval）
Time frame: From Day1 to Day36
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.
Electrocardiogram parameter（QTcF interval）
Time frame: From Day1 to Day36
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.
Electrocardiogram parameter(QRS interval)
Time frame: From Day1 to Day36
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.
Vital signs parameter（Body temperature）
Time frame: From Day1 to Day36
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.
Vital signs parameter（Blood pressure）
Time frame: From Day1 to Day36
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.
Vital signs parameter（Pulse）
Time frame: From Day1 to Day36
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.
Vital signs parameter（Respiration）
Time frame: From Day1 to Day36
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.
9 secondary outcomes
Cmax
Time frame: From Day1 to Day36
AUC0-t
Time frame: From Day1 to Day36
Tmax
Time frame: From Day1 to Day36
T1/2
Time frame: From Day1 to Day36
CL/F
Time frame: From Day1 to Day36
GIRmax
Time frame: From Day1 to Day36
tGIRmax
Time frame: From Day1 to Day36
AUCGIR
Time frame: From Day1 to Day36
ADA（Anti-Drug Antibody）
Time frame: From Day1 to Day36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HEC-151 Injection and Degludec insulin in people with Healthy Adult Male, run by Sunshine Lake Pharma Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chengyong Tang, Doctor (+8618983286980, 17235387@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: From Day1 to Day36). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.