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Phase 1 Study of KH607 Tablets

NCT06393803 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-05-07

No results posted yet for this study

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.

Conditions

  • Healthy

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.

Sponsors & Collaborators

  • Chengdu Kanghong Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-21
Primary Completion
2024-10-30
Completion
2024-10-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06393803 on ClinicalTrials.gov