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
Not provided
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of IMM-H014 on fasted condition, and characterize PK of IMM-H014 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either IMM-H014 or placebo.
The study is a randomized, double-blind phase 1 trial including 3 parts: single ascending dose (SAD) part, multiple ascending dose (MAD) part and food effect (FE) part.
SAD and MAD parts adopt "sentinel method "which2 healthy subjects first will receive IMM-H014, and if are evaluated to be tolerable, the remaining 8 subjects will be randomly assigned to receive IMM-H014 and placebo in a ratio of 3:1(10 in per experimental Cohort). Subjects in SAD will receive 12.5,37.5,75, 125, 225, 275, 325mg (Cohort 1-4 and Cohort 6-8) once daily respectively. Subjects in MAD will receive 37.5, 75, 125, 175, 225mg (Cohort 9 - Cohort 13) once daily for 7days respectively.
FE part is divided into two groups: 8 subjects will receive IMM-H014 and 2 subjects will receive placebo In group A .All 8 subjects will receive IMM-H014 in group B. Group A adopts "sentinel method ".The treatment in food effect consists of 2 periods, and subjects will receive175mg(SAD Cohort 5) on fasting and postprandial states respectively. There will be a 7-day wash out period between treatment periods. To monitor AEs, record abnormalities (12-lead ECG, Vital signs, Physical examination, Clinical Laboratory), and detect the pharmacokinetics of IMM-H014.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMM-H014 /Placebo(single dose) 12.5 mg (Cohort 1) | Experimental | IMM-H014 /Placebo tablets administered orally once daily under fasted condition. |
|
| IMM-H014 /Placebo((single dose) 37.5 mg Cohort(Cohort 2) | Experimental | IMM-H014 /Placebo tablets administered orally once daily under fasted condition. |
|
| IMM-H014 /Placebo(single dose) 75 mg (Cohort 3) | Experimental | IMM-H014 /Placebo tablets administered orally once daily under fasted condition. |
|
| IMM-H014 /Placebo(single dose) 125 mg(Cohort 4) | Experimental | IMM-H014 /Placebo tablets administered orally once daily under fasted condition. |
|
| IMM-H014 /Placebo(single dose and food effect) 175mg (Cohort 5) | Experimental | Period 1 (Day1 to Day4): Group A and Group B receive IMM-H014 /Placebo under the fasting or fed condition ,respectively on Day1. Period 2 (Day 8 to Day11): Group A and Group B receive IMM-H014 /Placebo under the fed or fasting condition ,respectively on Day8. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMM-H014 | Drug | SAD and MAD adopt "sentinel method "which 2 healthy subjects first will receive IMM-H014, and if are evaluated to be tolerable, the remaining 8 subjects will be randomly assigned to receive IMM-H014 and placebo in a ratio of 3:1(10 in per experimental Cohort). |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events following oral doses (single, multiple and food effect)of IMM-H014 and placebo | the adverse events are recorded according to the actual occurrence | through study completion, up to 11, 17, 18 days for SAD, MAD, FE part |
| Number of participants with abnormal laboratory tests results and abnormal physical exam findings | The data of the clinical research center is collected and analyzed according to the time point of the test flow chart | through study completion, up to 4, 10, 11 days for SAD, MAD, FE part |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters: AUClast(AUC0-t) | AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration. | Up to 4, 10, 11 days for SAD, MAD, FE part |
| PK parameters: AUCinf(AUC0-∞) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiqi Bai | Contact | 18943642700 | baishiqi@intelli-crown.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Zhang | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first Bethune hospital of Jilin University | Recruiting | Changchun | Jilin | China |
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Masking for Participant, Investigator and Clinical Research Associate
|
| IMM-H014 /Placebo(single dose) 225 mg (Cohort 6) | Experimental | IMM-H014 /Placebo tablets administered orally once daily under fasted condition. |
|
| IMM-H014 /Placebo(single dose) 275mg (Cohort 7) | Experimental | IMM-H014 /Placebo tablets administered orally once daily under fasted condition. |
|
| IMM-H014 /Placebo(single dose) 325 mg (Cohort 8) | Experimental | IMM-H014 /Placebo tablets administered orally once daily under fasted condition. |
|
| IMM-H014 /Placebo(multiple dose) tentative 37.5 mg(Cohort 9) | Experimental | IMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses). |
|
| IMM-H014 /Placebo(multiple dose) tentative 75 mg(Cohort 10) | Experimental | IMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses). |
|
| IMM-H014 /Placebo(multiple dose) tentative 125 mg(Cohort 11) | Experimental | IMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses). |
|
| IMM-H014 /Placebo(multiple dose) tentative 175 mg(Cohort 12) | Experimental | IMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses). |
|
| IMM-H014 /Placebo(multiple dose) tentative 225 mg(Cohort13) | Experimental | IMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses). |
|
| Placebo | Drug | SAD and MAD adopt "sentinel method "which 2 healthy subjects first will receive IMM-H014, and if are evaluated to be tolerable, the remaining 8 subjects will be randomly assigned to receive IMM-H014 and placebo in a ratio of 3:1(10 in per experimental Cohort). |
|
| IMM-H014 ( FE) | Drug | FE part is divided into two groups: 8 subjects will receive IMM-H014 and 2 subjects will receive placebo In group A .All 8 subjects will receive IMM-H014 in group B. Group A adopts "sentinel method ".The treatment in food effect consists of 2 periods. |
|
| Placebo ( FE) | Drug | FE part is divided into two groups: 8 subjects will receive IMM-H014 and 2 subjects will receive placebo In group A .All 8 subjects will receive IMM-H014 in group B. Group A adopts "sentinel method ".The treatment in food effect consists of 2 periods. |
|
AUCinf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).
| Up to 4, 10, 11 days for SAD, MAD, FE part |
| PK parameters: Cmax | Cmax is defined as the maximum observed concentration of drug in plasma. | Up to 4, 10, 11 days for SAD, MAD, FE part |
| PK parameters: Tmax | Tmax is defined as the time to maximum concentration. | Up to 4, 10, 11 days for SAD, MAD, FE part |
| PK parameters: t1/2 | t1/2z is defined as the time to decline half of the drug concentration in plasma. | Up to 4, 10, 11 days for SAD, MAD, FE part |
| PK parameters: CL/F | λz is defined as the ratio between the elimination of compound per unit time and the total amount of compound. | Up to 4, 10, 11 days for SAD, MAD, FE part |
| PK parameters: λz | λz is defined as the ratio between the elimination of compound per unit time and the total amount of compound. | Up to 4, 10, 11 days for SAD, MAD, FE part |
| Multiple-dose plasma PK parameter: Rac | Rac (Accumulation Index) is defined as the ratio between AUC0-XX in Day XX and AUC0-XX in Day1 | Up to 10 days |
| Multiple-dose plasma PK parameter: DF | DF is defined as the percentage of fluctuation in steady state is 100 * (Cmax, ss - Cmin, ss)/Cavg, ss | Up to 10 days |
| Multiple-dose plasma PK parameter: Cmin | Cmin is defined as the minimum observed concentration of drug in plasma at steady state. | Up to 10 days |
| Multiple-dose plasma PK parameter: Cmax | Cmax is defined as the maximum observed concentration of drug in plasma at steady state. | Up to 10 days |