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
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Adverse event
Overview
Brief Summary
Evaluate the safety, tolerability, PK/PD and immunogenicity characteristics of a single subcutaneous HEC-151 Injection solution in healthy participants
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
HEC-151 Injection, Insulin Degludec, placebo
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Arms & Interventions
HEC-151 Injection and placebo
The participants received an abdominal subcutaneous HEC-151 Injection or a placebo in the morning of Day 1.
Intervention: HEC-151 Injection and placebo (Drug)
Insulin Degludec
The participants received an abdominal subcutaneous injection of Insulin Degludec in the morning of Day 1.
Intervention: Degludec insulin (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- GIRmax(From Day1 to Day36)
- tGIRmax(From Day1 to Day36)
- AUCGIR(From Day1 to Day36)
- ADA（Anti-Drug Antibody）(From Day1 to Day36)