Phase 1 Study of KH607 Tablets
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of KH607 Tablets in Chinese Healthy Volunteers
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Oct 2023
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 21, 2023
CompletedFirst Submitted
Initial submission to the registry
January 4, 2024
CompletedFirst Posted
Study publicly available on registry
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2024
CompletedMay 7, 2024
May 1, 2024
1 year
January 4, 2024
May 6, 2024
Conditions
Outcome Measures
Primary Outcomes (5)
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.
Physical Examination
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.
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.
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.
Screening up to Part 1 Day3，Part 2 Day14.
Secondary Outcomes (14)
Columbia-Suicide Severity Rating Scale
Screening up to Part 1 Day3，Part 2 Day14.
Observed maximum plasma concentration (Cmax)
Up to 48 hours after dosing in Part 1.
Time to reach maximum plasma concentration (Tmax)
Up to 48 hours after dosing in Part 1.
Elimination Halflife (T1/2)
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）
Up to 48 hours after dosing in Part 1.
- +9 more secondary outcomes
Study Arms (11)
KH607 Cohort 1
EXPERIMENTALSubject received a single KH607 tablets dose of 2mg KH607 tablets or matching placebo.
KH607 Cohort 2
EXPERIMENTALSubject received a single KH607 tablets dose of 5mg KH607 tablets or matching placebo.
KH607 Cohort 3
EXPERIMENTALSubject received a single KH607 tablets dose of 10mg KH607 tablets or matching placebo.
KH607 Cohort 4
EXPERIMENTALSubject received a single KH607 tablets dose of 20mg KH607 tablets or matching placebo.
KH607 Cohort 5
EXPERIMENTALSubject received a single KH607 tablets dose of 30mg KH607 tablets or matching placebo.
KH607 Cohort 6
EXPERIMENTALSubject received a single KH607 tablets dose of 40mg KH607 tablets or matching placebo.
KH607 Cohort 7
EXPERIMENTALSubject received a single KH607 tablets dose of 50mg KH607 tablets or matching placebo.
KH607 Cohort 8
EXPERIMENTALSubject received a single KH607 tablets dose of 60mg KH607 tablets or matching placebo.
KH607 Cohort 9
EXPERIMENTALSubject received 10mg KH607 or matching placebo, oncely daily from Day 1 to Day 7.
KH607 Cohort 10
EXPERIMENTALSubjects receive 20mg KH607 or matching placebo, once daily from Day 1 to Day 7.
KH607 Cohort 11
EXPERIMENTALSubjects receive 30mg KH607 or matching placebo, once daily from Day 1 to Day 7.
Interventions
Subject receive KH607 tablets or placebo orally single dose or multiple doses.
Subject receive KH607 tablets or placebo orally single dose or multiple doses.
Subject receive KH607 tablets or placebo orally single dose or multiple doses.
Eligibility Criteria
You may qualify if:
- Adult, male and female volunteers, 18 to 55 years of age, inclusive.
- Male weight ≥ 50kg, female weight ≥ 45kg, and body mass index ≥ 19 to ≤ 28 kg/m2 at the screening period.
You may not qualify if:
- 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.
- 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.
- Subjects with SSS ≥3 or MOAA/S ≤4 during the screening period.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Anding Hospital Affiliated to Capital Medical University
Beijing, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2024
First Posted
May 1, 2024
Study Start
October 21, 2023
Primary Completion
October 30, 2024
Study Completion
October 30, 2024
Last Updated
May 7, 2024
Record last verified: 2024-05