Healthy Participants, Overweight or Obese Participants
Conditions
Brief summary
Clinical trials of IBI3040 with single-dose administration in healthy participants and multiple-dose administration in overweight or obese participants.
Interventions
DRUGSAD: subcutaneous injection in the abdomen
SAD: Single subcutaneous administration, with a safe follow-up period of 60 days
DRUGMAD: subcutaneous injection in the abdomen
MAD: Multiple administration, subcutaneous injection
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Part A and Part B cohorts 2-6 are randomized, double-blind trials (participants and investigators). From the start of randomization until the database is locked, blinded participants include participants, investigators (excluding non-blinded investigators from the SRC), and all participants who received the medication.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
All participants in Part A (SAD) and Part B (MAD) must meet inclusion criteria 1-3: * 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. Participants of Part A (SAD) also need to meet inclusion criteria 4-6: * 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. * 5\. During screening, 20 kg/m ² ≤BMI \<28 kg/m ²; * 6\. When screening, the standard weight should be ≥50 kg Participants of Part B (MAD) also need to meet inclusion criteria 7-8: * 7\. During screening, 24 kg/m2 ≤BMI ≤40 kg/m2; * 8\. The standard weight change within 3 months prior to screening should be no more than 5kg (reported by the participants themselves).
Exclusion criteria
All participants in Part A (SAD) and Part B (MAD) who meet any one of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAD: The incidence rate of serious adverse events (SAE) | through study completion, an average of 20 weeks | — |
| MAD: Number of subjects with clinically significant changes in physical examination results | through study completion, an average of 20 weeks | — |
| MAD: Number of subjects with clinically significant changes in vital signs | through study completion, an average of 20 weeks | Vital signs including body temperature, pulse, respiratory rate and blood pressure |
| MAD: Number of participants with abnormal laboratory tests results | through study completion, an average of 20 weeks | laboratory tests including Blood routine、Blood Biochemistry (including blood lipids)、Coagulation routine、Urine routine、blood amylase、blood lipase、Pregnancy test、Calcitonin and Glycated hemoglobin (HbA1c) |
| MAD: Number of subjects with clinically significant changes in twelve-lead electrocardiogram | through study completion, an average of 20 weeks | — |
| SAD: The incidence rate of adverse events (AE) | through study completion, an average of 60 days | — |
| SAD: The incidence rate of serious adverse events (SAE) | through study completion, an average of 60 days | — |
| SAD: Number of subjects with clinically significant changes in physical examination results | through study completion, an average of 60 days | — |
| SAD: Number of subjects with clinically significant changes in vital signs | through study completion, an average of 60 days | Vital signs including body temperature, pulse, respiratory rate and blood pressure |
| SAD: Number of participants with abnormal laboratory tests results | through study completion, an average of 60 days | laboratory tests including Blood routine、Blood Biochemistry (including blood lipids)、Coagulation routine、Urine routine、blood amylase、blood lipase、Pregnancy test、Calcitonin and Glycated hemoglobin (HbA1c) |
| SAD: Number of subjects with clinically significant changes in twelve-lead electrocardiogram | through study completion, an average of 60 days | — |
| MAD: The incidence rate of adverse events (AE) | through study completion, an average of 20 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| SAD: maximum concentration (Cmax) | through study completion, an average of 60 days |
| SAD: time to maximum concentration (Tmax) | through study completion, an average of 60 days |
| SAD: Anti-drug antibodies (ADA) | through study completion, an average of 60 days |
| SAD: apparent volume of distribution (V/F) | through study completion, an average of 60 days |
| SAD: half-life (T1/2) | through study completion, an average of 60 days |
| SAD: clearance (CL/F) | through study completion, an average of 60 days |
| SAD: neutralizing antibodies (NAb) | through study completion, an average of 60 days |
| MAD: area under the curve (AUC) | through study completion, an average of 20 weeks |
| MAD: maximum concentration (Cmax) | through study completion, an average of 20 weeks |
| MAD: time to maximum concentration (Tmax) | through study completion, an average of 20 weeks |
| MAD: clearance (CL/F) | through study completion, an average of 20 weeks |
| MAD: apparent volume of distribution (V/F) | through study completion, an average of 20 weeks |
| MAD: half-life (T1/2) | through study completion, an average of 20 weeks |
| MAD: Anti-drug antibodies (ADA) | through study completion, an average of 20 weeks |
| MAD: neutralizing antibodies (NAb) | through study completion, an average of 20 weeks |
| MAD: The change in body weight from baseline and the rate of change | through study completion, an average of 20 weeks |
| SAD: area under the curve (AUC) | through study completion, an average of 60 days |
Countries
China
Contacts
CONTACTShanyu Xu
Outcome results
None listed