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Phase 1 Study of KH607 Tablets
Sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd.
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.
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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2023-10-21
Completion Date
2024-10-30
Last Updated
2024-05-07
Healthy Volunteers
Yes
Conditions
Interventions
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 (1)
Beijing Anding Hospital Affiliated to Capital Medical University
Beijing, China