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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of IBI3032 administered orally. | Experimental | Part A |
|
| Single dose of placebo administered orally. | Placebo Comparator | Part A |
|
| Multiple doses of IBI3032 administered orally. | Experimental | Part B |
|
| Multiple doses of placebo administered orally. | Placebo Comparator | Part B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Single dose placebo IBI3032 administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with adverse events (AEs) | 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. | Part A: Baseline up to Day 15 |
| Number of Participants with adverse events (AEs) | 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. | Part B: Baseline up to Day 43 |
| Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug | A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module. | Part A: Baseline up to Day 15 |
| Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug | A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module. | Part B: Baseline up to Day 43 |
| Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Part A: Baseline up to Day 15 |
| Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. |
| Measure | Description | Time Frame |
|---|---|---|
| Under the Serum Concentration-time Curve (AUC) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. | Part A: Predose up to 168 hours postdose |
| Under the Serum Concentration-time Curve (AUC) of IBI3032 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dee Li | Contact | 18017984650 | dee.li@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| IBI3032 tablets | Drug | Single dose of IBI3032 administered orally |
|
| Part B: Baseline up to Day 43 |
To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity. |
| Part B: Predose up to 168 hours postdose |
| maximum concentration (Cmax) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. | Part A: Predose up to 168 hours postdose |
| maximum concentration (Cmax) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity. | Part B: Predose up to 168 hours postdose |
| time to maximum concentration (Tmax) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. | Part A: Predose up to 168 hours postdose |
| time to maximum concentration (Tmax) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity. | Part B: Predose up to 168 hours postdose |
| clearance (CL) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. | Part A: Predose up to 168 hours postdose |
| clearance (CL) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity. | Part B: Predose up to 168 hours postdose |
| apparent volume of distribution (V) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. | Part A: Predose up to 168 hours postdose |
| apparent volume of distribution (V) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity. | Part B: Predose up to 168 hours postdose |
| elimination half-life (T1/2) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. | Part A: Predose up to 168 hours postdose |
| elimination half-life (T1/2) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity. | Part B: Predose up to 168 hours postdose |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |