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RECRUITING
NCT06393803
PHASE1

Phase 1 Study of KH607 Tablets

Sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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

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.

Locations (1)

Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, China