Single-ascending Dose Study of HEC-151 Injection (NCT07376200) | Clinical Trial Compass
RecruitingPhase 1
Single-ascending Dose Study of HEC-151 Injection
China81 participantsStarted 2026-02-24
Plain-language summary
Evaluate the safety, tolerability, PK/PD and immunogenicity characteristics of a single subcutaneous HEC-151 Injection solution in healthy participants
Who can participate
Age range18 Years – 45 Years
SexMALE
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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;