Clinical Trials of IBI3035 in Healthy Subjects

ConditionHealthy Person

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexMale

Age18-45

SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

This study is a Phase I clinical trial that uses positive glucose clamping technology to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of IBI3035 with insulin injection (Awiqli?) after a single administration in healthy male subjects

Eligibility criteria

Qualifiers

Healthy male adult subjects aged 18 to 45 years (including 18 and 45 years, based on the date of signing the informed consent form) of Chinese nationality;

Body Mass Index (BMI) between 19.0 and 24.0 kg/m2 (including both values) at screening, and weight ≥ 50 kg;

Normal glucose tolerance at screening [3.9 mmol/L < fasting blood glucose < 6.1 mmol/L, and 2-hour post-glucose load blood glucose < 7.8 mmol/L in the oral glucose tolerance test (OGTT)]; normal insulin secretion function or abnormality without clinical significance as determined by the investigator [confirmed by the insulin release test (IRT)];

Glycated hemoglobin ≤ 6.0% at screening;

Disqualifiers

Known or suspected to be allergic to the investigational drug in this study;

Have taken any drugs that affect insulin hypoglycemic effects within 28 days before screening (such as corticosteroids, diuretics, epinephrine, salbutamol, glucagon, thyroid hormones, etc.);

Have a history of clinical significance as determined by the investigator at screening or before randomization, including diseases of the endocrine system, blood system, cardiovascular system, respiratory system, digestive system, urinary system, immune system, nervous system, or any other disease that can significantly alter the absorption, metabolism, or elimination of drugs;

Have a clear diagnosis of hyperglycemia or hypoglycemia within 3 months before screening;

Trial design

Treatments tested in this trial

IBI3035
Insulin icodec Injection

Treatment groups

144 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov