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This study is a single-center, randomized, double-blind, placebo-controlled study divided into a Single Ascending Dose (SAD) stage and a Multiple Ascending Dose (MAD) phase. The primary objective is to evaluate the safety and tolerability of KHN702 tablets in Chinese healthy volunteers(HVs).
This study consists of two parts: Part 1-SAD phase and Part 2- MAD phase. There will be 7 cohorts in Part 1 and 3 cohorts in Part 2.
The SAD study will enroll approximately 54 HVs across 7 dose cohorts. All participants in Part 1 will be administered with a single oral dose of KHN702 or its matching placebo under fasted condition.
Approximately 30 HVs will be enrolled in the multiple ascending dose study. All participants in Part 2 will received KHN702 or placebo once daily for continuous 7 days (QD x 7d) in a double-blind manner.
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 |
|---|---|---|---|
| KHN702 tablet-Part I | Experimental | All participants will receive single dose of KHN702 tablet or placebo. |
|
| KHN702 tablet-Part II | Experimental | All participants will receive mutiple doses of KHN702 tablet or placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHN702 tablet or placebo | Drug | Subject will receive a single KHN702 tablet or matching placebo orally in fasted 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 for Part 1, and Day 10 for Part 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702. | Part I: Day 1 to Day 4. Part II: Day 1 to Day 10. |
| Time to reach maximum observed concentration (Tmax) |
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inclusion criteria:
1.Age: 18 to 45 years old (inclusive), Male or female. 2.Body weight: ≥ 50 kg for male and ≥ 45 kg for female, body mass index: 19~26 kg/m2 (inclusive).
3. Effective contraception measures and no sperm/egg donation plan from signing the informed consent to 3 months after last dose.
4.Fully understand the procedures and sigh the informed consent. exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengchang Yang Sichuan Provincial People's Hospital, Medical Doctor | Contact | 86-28-87393401 | ymc681@126.com |
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| KHN702 tablet or placebo | Drug | All participants will receive KHN702 tablet or matching placebo orally once a day for 7 days in fasted state. |
|
To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702. |
| Part I: Day 1 to Day 4. Part II: Day 1 to Day 10. |
| Area under plasma concentration-time curve from zero to infinity (AUC0-inf) | To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702. | Part I: Day 1 to Day 4. Part II: Day 1 to Day 10. |
| Area under the plasma concentration-curve across the dosing interval (AUC0-tau) | To characterise the steady state PK of KHN702 following oral multiple administration of KHN702. | Day 1 to Day 10. |
| Terminal elimination half-life (t1/2) | To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702. | Part I: Day 1 to Day 4. Part II: Day 1 to Day 10. |
| Apparent total body clearance (CL/F) | To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702. | Part I: Day 1 to Day 4. Part II: Day 1 to Day 10. |
| Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) | To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702. | Part I: Day 1 to Day 4. Part II: Day 1 to Day 10. |