Phase 1 Study of KH607 Tablets

May 6, 2024 updated by: Chengdu Kanghong Pharmaceutical Group Co., Ltd.

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of KH607 Tablets in Chinese Healthy Volunteers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Anding Hospital Affiliated to Capital Medical University
        • Contact:
          • Gang Wang, Medical Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KH607 Cohort 1
Subject received a single KH607 tablets dose of 2mg KH607 tablets or matching placebo.
Drug: 2mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose.
Experimental: KH607 Cohort 2
Subject received a single KH607 tablets dose of 5mg KH607 tablets or matching placebo.
Drug: 5mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose.
Experimental: KH607 Cohort 3
Subject received a single KH607 tablets dose of 10mg KH607 tablets or matching placebo.
Drug: 10mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose or multiple doses.
Experimental: KH607 Cohort 4
Subject received a single KH607 tablets dose of 20mg KH607 tablets or matching placebo.
Drug: 20mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose or multiple doses.
Experimental: KH607 Cohort 5
Subject received a single KH607 tablets dose of 30mg KH607 tablets or matching placebo.
Drug: 30mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose or multiple doses.
Experimental: KH607 Cohort 6
Subject received a single KH607 tablets dose of 40mg KH607 tablets or matching placebo.
Drug: 40mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose.
Experimental: KH607 Cohort 7
Subject received a single KH607 tablets dose of 50mg KH607 tablets or matching placebo.
Drug: 50mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose.
Experimental: KH607 Cohort 8
Subject received a single KH607 tablets dose of 60mg KH607 tablets or matching placebo.
Drug: 60mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose.
Experimental: KH607 Cohort 9
Subject received 10mg KH607 or matching placebo, oncely daily from Day 1 to Day 7.
Drug: 10mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose or multiple doses.
Experimental: KH607 Cohort 10
Subjects receive 20mg KH607 or matching placebo, once daily from Day 1 to Day 7.
Drug: 20mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose or multiple doses.
Experimental: KH607 Cohort 11
Subjects receive 30mg KH607 or matching placebo, once daily from Day 1 to Day 7.
Drug: 30mg KH607 tablets
Subject receive KH607 tablets or placebo orally single dose or multiple doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12-lead ECGs
Time Frame: Screening up to Part 1 Days, Part 2 Day14.
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.
12-lead ECGs
Time Frame: Screening up to Part 2 Day14.
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.
Stanford Sleepiness Scale
Time Frame: Screening up to Part 1 Day3，Part 2 Day14.
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.
Modified Observer's Assessment of Alertness/Sedation scale
Time Frame: Screening up to Part 1 Day3，Part 2 Day14.
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.
Physical Examination
Time Frame: Screening up to Part 1 Days, Part 2 Day14.
Screening up to Part 1 Days, Part 2 Day14.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Columbia-Suicide Severity Rating Scale
Time Frame: Screening up to Part 1 Day3，Part 2 Day14.
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.
Observed maximum plasma concentration (Cmax)
Time Frame: Up to 48 hours after dosing in Part 1.
Up to 48 hours after dosing in Part 1.
Time to reach maximum plasma concentration (Tmax)
Time Frame: Up to 48 hours after dosing in Part 1.
Up to 48 hours after dosing in Part 1.
Elimination Halflife (T1/2)
Time Frame: Up to 48 hours after dosing in Part 1.
Up to 48 hours after dosing in Part 1.
Area under the concentration-time curve from time zero to last time of quantifiable concentration（AUC0-t）
Time Frame: Up to 48 hours after dosing in Part 1.
Up to 48 hours after dosing in Part 1.
Apparent Distribution Volume (Vd)
Time Frame: Up to 48 hours after dosing in Part 1.
Up to 48 hours after dosing in Part 1.
Apparent Total Plasma Clearance (CL)
Time Frame: Up to 48 hours after dosing in Part 1.
Up to 48 hours after dosing in Part 1.
Elimination Rate Constant (Kel)
Time Frame: Up to 48 hours after dosing in Part 1.
Up to 48 hours after dosing in Part 1.
Mean Residence Time(MRT)
Time Frame: Up to 48 hours after dosing in Part 1.
Up to 48 hours after dosing in Part 1.
Steady-state valley concentration（Css,min）
Time Frame: Up to 24 hours after Day7 dosing in Part 2.
Up to 24 hours after Day7 dosing in Part 2.
Steady-state peak concentration（Css,max）
Time Frame: Up to 24 hours after Day7 dosing in Part 2.
Up to 24 hours after Day7 dosing in Part 2.
Mean steady-state blood concentration（Css,av）
Time Frame: Up to 24 hours after Day7 dosing in Part 2.
Up to 24 hours after Day7 dosing in Part 2.
Steady state area under the curve（AUC0-tau）
Time Frame: Up to 24 hours after Day7 dosing in Part 2.
Up to 24 hours after Day7 dosing in Part 2.
Accumulation Index（Rac）
Time Frame: Up to 24 hours after Day7 dosing in Part 2.
Up to 24 hours after Day7 dosing in Part 2.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Kanghong Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2023

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • KH607-30101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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