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
Qualifiers
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
Treatments tested in this trial
- HEC-151 Injection
- Degludec insulin
- Placebo
Treatment groups
81 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov