Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, PK and food effect of a single dose of IBI3032 in healthy participants. This is a single ascending dose (SAD) study. Approximately 40 healthy participants are expected to be enrolled in this study. The screening period is 4 weeks. Eligible participants will be divided into 4 cohorts. Cohort1,2,4 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. Cohort 3 consisted of 16 participants used a two-cycle, double-crossover design, who were randomly divided into four groups at a ratio of 3:1:3:1: Cohort 3-1-IBI3032, cohort 3-1-placebo, cohort 3-2-IBI3032, and cohort 3-2-placebo, each subject underwent two cycles of the trial. In cohort 3-1, the first cycle was given on fasted administration, and the second cycle was given after breakfast. In cohort 3-2, the first cycle was administered after breakfast intake, and the second cycle was administered fasted. The washout period for cohort 3-1 and cohort 3-2 was 8 days.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose1 of IBI3032 administered orally. | Experimental | dose1 IBI3032 |
|
| Single dose4 of placebo administered orally. | Placebo Comparator | dose4 placebo |
|
| Single dose4 of IBI3032 administered orally. | Experimental | dose4 IBI3032 |
|
| D1:Single dose3-1 of placebo administered orally. D9:Single dose3-1 of placebo administered orally. | Active Comparator | D1: Fasted administer D9:Administer after meal |
|
| Single dose2 of IBI3032 administered orally. | Experimental | dose2 IBI3032 |
|
| D1:Single dose3-2 of placebo administered orally. D9:Single dose3-2 of placebo administered orally. | Active Comparator | D1:Administer after meal D9: Fasted administer |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Placebo (without active ingredients) (cohort1, 2,4) Method of administration: oral, fasted administration. Placebo (without active ingredients) (cohort3) Method of administration: oral, administration after meal. |
| 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 | (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) 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 | (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) 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. | (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Frist Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D1:Single dose3-2 of IBI3032 administered orally. D9:Single dose3-2 of IBI3032 administered orally. | Experimental | D1:Administer after meal D9: Fasted administer |
|
| D1:Single dose3-1 of IBI3032 administered orally. D9:Single dose3-1 of IBI3032 administered orally. | Experimental | D1: Fasted administer D9:Administer after meal |
|
| Single dose1 of placebo administered orally. | Placebo Comparator | dose1 placebo |
|
| Single dose2 of placebo administered orally. | Placebo Comparator | dose2 placebo |
|
| IBI3032 | Drug | IBI3032: (cohort1, 2,4) Method of administration: oral, fasted administration. IBI3032: (cohort3) Method of administration: oral, administration after meal. |
|
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 |