Single-ascending Dose Study of HEC-151 Injection
ConditionHealthy Adult Male
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorSunshine Lake Pharma Co., Ltd.
About this trial
Evaluate the safety, tolerability, PK/PD and immunogenicity characteristics of a single subcutaneous HEC-151 Injection solution in healthy participants
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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];
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
HEC-151 Injection
DrugSubcutaneous injection in the abdominal area
Degludec insulin
DrugSubcutaneous injection in the abdominal area
Placebo
DrugSubcutaneous injection in the abdominal area
Treatment groups
81 Participants
are divided into 3 treatment groupsGroup A: HEC-151 InjectionExperimental treatment 1 intervention
Group B: Insulin DegludecActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adverse event
Frequency, type and severity of adverse events/serious adverse events.
Time frame
From Day1 to Day362
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 Day363
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 Day364
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 Day36Secondary outcomes
1
Cmax
Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.
Time frame
From Day1 to Day362
AUC0-t
Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.
Time frame
From Day1 to Day363
Tmax
Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.
Time frame
From Day1 to Day364
T1/2
Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.
Time frame
From Day1 to Day36Sponsors and contacts
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Source ClinicalTrials.gov