Phase 1 Study of KH607 Tablets

Chengdu Kanghong Pharmaceutical Group Co., Ltd.88 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

2mg KH607 tabletsDRUG

Subject receive KH607 tablets or placebo orally single dose.

5mg KH607 tabletsDRUG

Subject receive KH607 tablets or placebo orally single dose.

10mg KH607 tabletsDRUG

Subject receive KH607 tablets or placebo orally single dose or multiple doses.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

12-lead ECGs

Using a standard 12-lead ECG machine that automatically calculates heart rate and measures PR interval, RR interval, QRS interval, QT interval and QTc interval. ECGs will be reviewed by the Investigator on an ongoing basis as safety assessments.

Time frame: Screening up to Part 1 Days, Part 2 Day14.

Physical Examination

Time frame: Screening up to Part 1 Days, Part 2 Day14.

12-lead ECGs

Using a standard 12-lead ECG machine that automatically calculate heart rate and measures PR interval, RR interval, QRS interval, QT interval, QTc interval. ECGs will be reviewed by the Investigator on an ongoing basis as safety assessments.

Time frame: Screening up to Part 2 Day14.

Stanford Sleepiness Scale

Participants rate their current sleepiness on a scale of 1 to 7, where scale of 1 indicates feeling active, vital, alert, or wide awake. Scale of 7 indicates no longer fighting sleep, sleep onset soon, and having dream-like thoughts.

Time frame: Screening up to Part 1 Day3，Part 2 Day14.

Modified Observer's Assessment of Alertness/Sedation scale

The MOAA/S ranges from 0 to 5, with a score of 5 defined as awake or minimally sedated, and a score of 0 defined as general anaesthesia.

Time frame: Screening up to Part 1 Day3，Part 2 Day14.

Secondary Outcomes

Columbia-Suicide Severity Rating Scale

The C-SSRS scale consists of three subscales: suicidal ideation, intensity of ideation and suicidal behavior.

Time frame: Screening up to Part 1 Day3，Part 2 Day14.

Observed maximum plasma concentration (Cmax)

Central Contacts

Ling Song

CONTACT

028-81258178 022516@cnkh.com

Data from ClinicalTrials.gov

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