Part A: Healthy Part B: Overweight or Obesity
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled phase 1 clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single ascending dose of IBI3032 in healthy participants and multiple ascending doses of IBI3032 in participants with overweight or obesity. It consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy participants, and Part B is a multiple ascending dose (MAD) study in participants with overweight or obesity during the 4-week treatment period.
Interventions
DRUGPlacebo
Single dose placebo IBI3032 administered orally
DRUGIBI3032 tablets
Single dose of IBI3032 administered orally
Sponsors
Innovent Biologics Technology Limited (Shanghai R&D Center)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female aged 18-65 years (inclusive) at the time of informed consent. 2. Participants must understand the procedures and methods of this study, be willing to complete the study in strict accordance with the clinical study protocol, and voluntarily sign the informed consent form.
Exclusion criteria
1. The investigator suspects that the participant may be allergic to any component of the study drug or GLP-1 receptor agonists, or have used GLP-1 receptor agonists within 3 months prior to screening. 2. History of diabetes, or HbA1c ≥ 6.5% and fasting blood glucose \< 3.9 mmol/L or ≥ 7.0 mmol/Lat screening. 3. Presence of any other abnormalities in vital signs and laboratory tests that are clinically significant as judged by the investigator at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with adverse events (AEs) | Part A: Baseline up to Day 15 | An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. |
| Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug | Part A: Baseline up to Day 15 | A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module. |
| Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | Part A: Baseline up to Day 15 | A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Under the Serum Concentration-time Curve (AUC) of IBI3032 | Part A: Predose up to 168 hours postdose | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. |
| maximum concentration (Cmax) of IBI3032 | Part A: Predose up to 168 hours postdose | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. |
| time to maximum concentration (Tmax) of IBI3032 | Part A: Predose up to 168 hours postdose | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. |
| clearance (CL) of IBI3032 | Part A: Predose up to 168 hours postdose | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. |
| apparent volume of distribution (V) of IBI3032 | Part A: Predose up to 168 hours postdose | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. |
| elimination half-life (T1/2) of IBI3032 | Part A: Predose up to 168 hours postdose | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. |
Countries
China
Outcome results
None listed