Clinical Trials of IBI3040 in Healthy Participants and Overweight or Obese Participants

ConditionsHealthy Participants Overweight or Obese Participants

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

Clinical trials of IBI3040 with single-dose administration in healthy participants and multiple-dose administration in overweight or obese participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1.The age at the time of informed consent should be between 18 and 65 years old (including both values), and there is no gender restriction.

2.Female participants who are fertile and male participants whose partners are fertile must agree to use the contraceptive methods specified in the protocol during the study period and within 90 days after the last administration. The pregnancy test results of female participants with fertility before randomization must be negative. Female participants should not breastfeed. Male/female participants must be willing to avoid donating sperm/eggs during the study period and within 90 days after the last administration.

3. Be able to understand the procedures and methods of this research, be willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.

4. Participants who were determined by the researchers to be normal or abnormal based on the results of various examinations such as medical history, vital signs, physical examination, 12-lead electrocardiogram, laboratory tests, infectious disease screening, chest X-ray, and abdominal color Doppler ultrasound, but were determined by the researchers to have no clinical significance.

Disqualifiers

1.Participants may be allergic to any component of the investigational drug, GLP-1 or Amylin receptor agonists (see Appendix 3 for details), or have used GLP-1 or Amylin receptor agonists within 3 months prior to screening;

2. A history of diabetes, or a glycated hemoglobin level of ≥6.5% during the screening period, or a fasting blood glucose level of ≥7.0 mmol/L;

3. Previous history of thyroid C-cell carcinoma, multiple endocrine adenomatosis (MEN) 2A or 2B, or related family history, or calcitonin ≥20 ng/L at screening;

4. A history of acute or chronic pancreatitis in the past, or amylase or lipase >1.5× upper limit of the normal range (ULN) at the time of screening;

Trial design

Design model

Parallel

Treatments tested in this trial

SAD: subcutaneous injection in the abdomen
Drug
SAD: Single subcutaneous administration, with a safe follow-up period of 60 days
MAD: subcutaneous injection in the abdomen
Drug
MAD: Multiple administration, subcutaneous injection

Treatment groups

96 Participants

are divided into 3 treatment groups

Group A: IBI3040Experimental treatment 2 interventions

Group B: IBI362Active comparator 1 intervention

Group C: IBI3040 PlaceboPlacebo comparator 2 interventions