NCT06393803

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	2mg KH607 tablets	Subject receive KH607 tablets or placebo orally single dose.
DRUG	5mg KH607 tablets	Subject receive KH607 tablets or placebo orally single dose.
DRUG	10mg KH607 tablets	Subject receive KH607 tablets or placebo orally single dose or multiple doses.
DRUG	20mg KH607 tablets	Subject receive KH607 tablets or placebo orally single dose or multiple doses.
DRUG	30mg KH607 tablets	Subject receive KH607 tablets or placebo orally single dose or multiple doses.
DRUG	40mg KH607 tablets	Subject receive KH607 tablets or placebo orally single dose.
DRUG	50mg KH607 tablets	Subject receive KH607 tablets or placebo orally single dose.
DRUG	60mg KH607 tablets	Subject receive KH607 tablets or placebo orally single dose.

Timeline

• Start date: 2023-10-21
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2024-05-01
• Last updated: 2024-05-07

Locations

1 site across 1 country: China