Phase 1 Study of KH607 Tablets

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06393803
• Other study ID #: KH607-30101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 21, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: May 2024
• Source: Chengdu Kanghong Pharmaceutical Group Co., Ltd.
• Contact: Ling Song
• Phone: 028-81258178
• Email: 022516[@]cnkh.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 2mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose.
• 5mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose.
• 10mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose or multiple doses.
• 20mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose or multiple doses.
• 30mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose or multiple doses.
• 40mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose.
• 50mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose.
• 60mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose.

Locations

Country	Name	City	State
China	Beijing Anding Hospital Affiliated to Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Kanghong Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Screening up to Part 1 Days, Part 2 Day14.
Primary	Physical Examination		Screening up to Part 1 Days, Part 2 Day14.
Primary	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.	Screening up to Part 2 Day14.
Primary	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.	Screening up to Part 1 Day3,Part 2 Day14.
Primary	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.	Screening up to Part 1 Day3,Part 2 Day14.
Secondary	Columbia-Suicide Severity Rating Scale	The C-SSRS scale consists of three subscales: suicidal ideation, intensity of ideation and suicidal behavior.	Screening up to Part 1 Day3,Part 2 Day14.
Secondary	Observed maximum plasma concentration (Cmax)		Up to 48 hours after dosing in Part 1.
Secondary	Time to reach maximum plasma concentration (Tmax)		Up to 48 hours after dosing in Part 1.
Secondary	Elimination Halflife (T1/2)		Up to 48 hours after dosing in Part 1.
Secondary	Area under the concentration-time curve from time zero to last time of quantifiable concentration(AUC0-t)		Up to 48 hours after dosing in Part 1.
Secondary	Apparent Distribution Volume (Vd)		Up to 48 hours after dosing in Part 1.
Secondary	Apparent Total Plasma Clearance (CL)		Up to 48 hours after dosing in Part 1.
Secondary	Elimination Rate Constant (Kel)		Up to 48 hours after dosing in Part 1.
Secondary	Mean Residence Time(MRT)		Up to 48 hours after dosing in Part 1.
Secondary	Steady-state valley concentration(Css,min)		Up to 24 hours after Day7 dosing in Part 2.
Secondary	Steady-state peak concentration(Css,max)		Up to 24 hours after Day7 dosing in Part 2.
Secondary	Mean steady-state blood concentration(Css,av)		Up to 24 hours after Day7 dosing in Part 2.
Secondary	Steady state area under the curve(AUC0-tau)		Up to 24 hours after Day7 dosing in Part 2.
Secondary	Accumulation Index(Rac)		Up to 24 hours after Day7 dosing in Part 2.