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| Name | Class |
|---|---|
| Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd. | UNKNOWN |
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The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults
This is a Phase 1, randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability and Pharmacokinetic of of ND-003 in healthy adults volunteers, and then evaluate food effects.
The study will be conducted in three parts: Part A-Single ascending dose (SAD) , Part B-Multiple ascending dose (MAD) and Part C-Food Effect. Each subject will be enrolled in only one cohort of either Parts A or B or C of the study, to receive only one dose regimen during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ND-003 40mg | Experimental | SAD(Single Ascending Dose) Cohort 1: Participants were orally administered 40mg of ND-003 or matched placebo once. |
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| ND-003 80mg | Experimental | SAD Cohort 2: Participants were orally administered 80mg of ND-003 or matched placebo once. |
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| ND-003 160mg | Experimental | SAD Cohort 3: Participants were orally administered 160mg of ND-003 or matched placebo once. |
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| ND-003 240mg | Experimental | SAD Cohort 4: Participants were orally administered 240mg of ND-003 or matched placebo once. |
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| ND-003 300mg | Experimental | SAD Cohort 5: Participants were orally administered 300mg of ND-003 or matched placebo once. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ND-003 40mg | Drug | Participants receive 40mg ND-003 tablets once. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) | Number and type of participants with treatment-related adverse events | through study completion, an average of 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| maximum concentration (Cmax) | The drug maximum concentration reaches when the absorption rate is equal to the elimination rate at a single dose. | Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| Time to maximum concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaojun Shi, PhD | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | China |
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Double-blind
| ND-003_Dose 1 | Experimental | MAD (Multiple Ascending Dose)Cohort 1:The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days. |
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| ND-003_Dose 2 | Experimental | MAD Cohort 2: The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days. |
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| ND-003_Dose 3 | Experimental | MAD Cohort 3:The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days. |
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| Food effect_Cohort 1 | Experimental | Food effect Cohort 1: The dose of ND-003 tablets will be determined based on the results of the SAD and MAD. Participants will be orally administered in fasting condition in day 1 and then in fed condition in day 8. |
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| Food effect_Cohort 2 | Experimental | Food effect Cohort 2: The dose of ND-003 tablets will be determined based on the results of the SAD and MAD. Participants will be orally administered in fed condition in day 1 and then in fasting condition in day 8. |
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| ND-003 placebo 40mg |
| Drug |
Participants receive placebo tablet matching to receive 40mg of ND-003. |
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| ND-003 80mg | Drug | Participants receive 80mg ND-003 tablets once. |
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| ND-003 placebo 80mg | Drug | Participants receive placebo tablet matching to receive 80mg of ND-003. |
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| ND-003 160mg | Drug | Participants receive 160mg ND-003 tablets once. |
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| ND-003 placebo 160mg | Drug | Participants receive placebo tablet matching to receive 160mg of ND-003. |
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| ND-003 240mg | Drug | Participants receive 240mg ND-003 tablets once. |
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| ND-003 placebo 240mg | Drug | Participants receive placebo tablet matching to receive 240mg of ND-003. |
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| ND-003 300mg | Drug | Participants receive 300mg ND-003 tablets once. |
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| ND-003 placebo 300mg | Drug | Participants receive placebo tablet matching to receive 300mg of ND-003. |
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| MAD_ND003_Dose 1 | Drug | Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD. |
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| MAD_placebo_Dose 1 | Drug | Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 1 |
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| MAD_ND003_Dose 2 | Drug | Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD. |
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| MAD_placebo_Dose 2 | Drug | Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 2 |
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| MAD_ND003_Dose 3 | Drug | Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD. |
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| MAD_ placebo_Dose 3 | Drug | Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 3 |
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| Food effect_Cohort 1 | Drug | Firstly orally administrated ND-003 tablets in fast state and then in fed state after a 7-day washout period. Wherein, the dose will be determined based on the results of SAD and MAD. |
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| Food effect_Cohort 2 | Drug | Firstly orally administrated ND-003 tablets in fed state and then in fast state after a 7-day washout period. Wherein, the dose will be determined based on the results of SAD and MAD. |
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Time required to reach peak drug concentration after a single administration. |
| Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| Elimination Half-life (t1/2) | Elimination Half-life (t1/2) refers to the time required to eliminate 50% of the drug from the body. | Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| Clearance (CLz/F) | Clearance (CLz/F) describes how the body effectively eliminate drugs from the systemic circulation, typically defined as the volume of drug-containing plasma eliminated from the body per unit time. | Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| AUC from time 0 to last time of quantifiable concentration (AUC0-t) | Area under the plasma concentration-time curve from the initial administration to the last measurable concentration point. | Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose |