Clinical trial NCT06393803: Phase 1 Study of KH607 Tablets
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of KH607 Tablets in Chinese Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was a single-center, randomized, double-blind, placebo-controlled study divided into a Single Ascending Dose (SAD) stage and a Multiple Ascending Dose (MAD) stage. The primary objective was to evaluate the safety and tolerability of KH607 tablets in Chinese healthy volunteers.

Detailed description: This study consists of two parts: Part 1-SAD phase and Part 2- MAD phase. There will be eight cohorts in Part 1 and three cohorts in Part 2 of this study.

The SAD study will enroll approximately 58 HVs across 8 dose cohorts. The dose cohorts will include the following dose levels: 2 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50mg and 60 mg. All participants in Part 1 will be administered with a single oral dose of KH607 or its matching placebo under fasted condition.

Approximately 30 HVs will be enrolled in the multiple ascending dose study. The dose cohorts will include the following dose levels: 10 mg, 20 mg, 30 mg.At each cohort, 10 subjects will be randomized in a ratio of 8:2 to be receive KH607 or placebo once daily for continuous 7 days (QDx7d) in a double-blind manner.

Additionally, this study will explore the effect of food on the PK of a single oral administration of KH607 in one selected SAD cohort.

Eligibility criteria: Inclusion Criteria:

1. Adult, male and female volunteers, 18 to 55 years of age, inclusive.
2. Male weight ≥ 50kg, female weight ≥ 45kg, and body mass index ≥ 19 to ≤ 28 kg/m2 at the screening period.

Exclusion Criteria:

1. Vulnerable groups include the Investigator and his or her immediate family members (spouse, parents, children, siblings), non-immediate family members involved in the study, or individuals who may be participating under coercion or undue influence.
2. Subjects whose C-SSRS suggests that they are at risk for suicide at the screening period, or with the risk for suicide based on the Investigator's clinical judgment, or with a history of suicidal or self-harming behavior.
3. Subjects with SSS ≥3 or MOAA/S ≤4 during the screening period.
4. Subjects with a history of surgery for gastrointestinal disorders or current GI disorders that may interfere with drug absorption, or who have undergone major surgery within the 3 months prior to the screening period.

Primary outcomes:
measure: 12-lead ECGs
timeFrame: Screening up to Part 1 Days, Part 2 Day14.
measure: Physical Examination
timeFrame: Screening up to Part 1 Days, Part 2 Day14.
measure: 12-lead ECGs
timeFrame: Screening up to Part 2 Day14.
measure: Stanford Sleepiness Scale
timeFrame: Screening up to Part 1 Day3，Part 2 Day14.
measure: Modified Observer's Assessment of Alertness/Sedation scale
timeFrame: Screening up to Part 1 Day3，Part 2 Day14.
Secondary outcomes:
measure: Columbia-Suicide Severity Rating Scale
timeFrame: Screening up to Part 1 Day3，Part 2 Day14.
measure: Observed maximum plasma concentration (Cmax)
timeFrame: Up to 48 hours after dosing in Part 1.
measure: Time to reach maximum plasma concentration (Tmax)
timeFrame: Up to 48 hours after dosing in Part 1.
measure: Elimination Halflife (T1/2)
timeFrame: Up to 48 hours after dosing in Part 1.
measure: Area under the concentration-time curve from time zero to last time of quantifiable concentration（AUC0-t）
timeFrame: Up to 48 hours after dosing in Part 1.
measure: Apparent Distribution Volume (Vd)
timeFrame: Up to 48 hours after dosing in Part 1.
measure: Apparent Total Plasma Clearance (CL)
timeFrame: Up to 48 hours after dosing in Part 1.
measure: Elimination Rate Constant (Kel)
timeFrame: Up to 48 hours after dosing in Part 1.
measure: Mean Residence Time(MRT)
timeFrame: Up to 48 hours after dosing in Part 1.
measure: Steady-state valley concentration（Css,min）
timeFrame: Up to 24 hours after Day7 dosing in Part 2.
measure: Steady-state peak concentration（Css,max）
timeFrame: Up to 24 hours after Day7 dosing in Part 2.
measure: Mean steady-state blood concentration（Css,av）
timeFrame: Up to 24 hours after Day7 dosing in Part 2.
measure: Steady state area under the curve（AUC0-tau）
timeFrame: Up to 24 hours after Day7 dosing in Part 2.
measure: Accumulation Index（Rac）
timeFrame: Up to 24 hours after Day7 dosing in Part 2.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital Affiliated to Capital Medical University
Study officials:
References: