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This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, and PK of a single dose of IBI3032 in healthy participants. This is a single ascending dose (SAD) study. Approximately 32 healthy participants are expected to be enrolled in this study.
The screening period is 4 weeks. Eligible participants will be divided into 4 cohorts. Each cohort consisted of 8 healthy participants who will be randomized in a 6:2 ratio to receive a single dose of IBI3032 or placebo. The safety follow-up period is 15 days. This study is for research purposes only, and is not intended to treat any medical condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose4 of IBI3032 administered orally. | Experimental | dose4 IBI3032 |
|
| Single dose3 of IBI3032 administered orally. | Experimental | dose3 IBI3032 |
|
| Single dose4 of placebo administered orally. | Placebo Comparator | dose4 placebo |
|
| Single dose1 of IBI3032 administered orally. | Experimental | dose1 IBI3032 |
|
| Single dose3 of placebo administered orally. | Placebo Comparator | dose3 placebo |
|
| Single dose1 of placebo administered orally. | Placebo Comparator | dose1 placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI3032 | Drug | IBI3032: Method of administration: oral, fasted administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | Baseline up to Day 15 |
| 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. | Predose up to 168 hours postdose |
| maximum concentration (Cmax) of IBI3032 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| lily Zhang | Contact | 13603216253 | lily.zhang@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Clinical Research | Recruiting | Lenexa | Kansas | 66219 | United States |
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| Single dose2 of IBI3032 administered orally. | Experimental | dose2 IBI3032 |
|
| Single dose2 of placebo administered orally. | Placebo Comparator | dose2 placebo |
|
| placebo | Drug | Placebo (without active ingredients) Method of administration: oral, fasted administration. |
|
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
| 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. | 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. | 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. | 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. | Predose up to 168 hours postdose |