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This is a single-center, randomized, double-blind, placebo-controlled study . The objective is to evaluate the safety , tolerability and PK profile of KHN707 tablets in Chinese healthy participants.
This study will enroll approximately 38 participants across 5 dose cohorts. Participants will be administered with a single dose or two doses of KHN707 or its matching placebo under a fasting or fed state.
The safety and tolerability will be evaluated by monitoring and assessment of AEs, clinical laboratory tests (hematology, urinalysis, biochemistry, coagulation, etc.), physical examination findings, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHN707 tablets | Experimental | All participants will receive a single dose or two doses of KHN707 tablets . |
|
| Placebo | Placebo Comparator | All participants will receive a single dose or two doses of the placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHN707 tablet | Drug | Participants will receive a single dose or two doses of KHN707 tablets orally in a fasting or fed state. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events (AEs) | Incidence and severity of adverse events (AEs), vital signs, physical examination, laboratory tests, electrocardiogram (ECG), etc. | From screening to Day 4 . |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | To characterise the PK of KHN707 following oral administration of KHN707. | Day 1 to Day 3. |
| Time to reach maximum observed concentration (Tmax) | To characterise the PK of KHN707 following oral administration of KHN707. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chongyuan Xu | Contact | 86-13926186470 | nflcyljd@smu.edu.cn |
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| Placebo | Drug | All participants will receive a single dose or two doses of the placebo in a fasting or fed state. |
|
| Day 1 to Day 3. |
| Area under plasma concentration-time curve from zero to infinity (AUC0-inf) | To characterise the PK of KHN707 following oral administration of KHN707. | Day 1 to Day 3. |
| Terminal elimination half-life (t1/2) | To characterise the PK of KHN707 following oral administration of KHN707. | Day 1 to Day 3. |
| Apparent total body clearance (CL/F) | To characterise the PK of KHN707 following oral administration of KHN707. | Day 1 to Day 3. |
| Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) | To characterise the PK of KHN707 following oral administration of KHN707. | Day 1 to Day 3. |