Phase 1 Study of KH607 Tablets

Kanghong Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: 40mg KH607 tablets; Drug: 50mg KH607 tablets; Drug: 10mg KH607 tablets; Drug: 30mg KH607 tablets; Drug: 2mg KH607 tablets; Drug: 60mg KH607 tablets; Drug: 5mg KH607 tablets; Drug: 20mg KH607 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06393803

KH607-30101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult, male and female volunteers, 18 to 55 years of age, inclusive.
2. Male weight ≥ 50kg, female weight ≥ 45kg, and body mass index ≥ 19 to ≤ 28 kg/m2 at the screening period.

Exclusion criteria

1. 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.
2. 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.
3. Subjects with SSS ≥3 or MOAA/S ≤4 during the screening period.
4. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 11 patient groups

KH607 Cohort 1

Experimental group

Description:

Subject received a single KH607 tablets dose of 2mg KH607 tablets or matching placebo.

Treatment:

Drug: 2mg KH607 tablets

KH607 Cohort 2

Experimental group

Description:

Subject received a single KH607 tablets dose of 5mg KH607 tablets or matching placebo.

Treatment:

Drug: 5mg KH607 tablets

KH607 Cohort 3

Experimental group

Description:

Subject received a single KH607 tablets dose of 10mg KH607 tablets or matching placebo.

Treatment:

Drug: 10mg KH607 tablets

KH607 Cohort 4

Experimental group

Description:

Subject received a single KH607 tablets dose of 20mg KH607 tablets or matching placebo.

Treatment:

Drug: 20mg KH607 tablets

KH607 Cohort 5

Experimental group

Description:

Subject received a single KH607 tablets dose of 30mg KH607 tablets or matching placebo.

Treatment:

Drug: 30mg KH607 tablets

KH607 Cohort 6

Experimental group

Description:

Subject received a single KH607 tablets dose of 40mg KH607 tablets or matching placebo.

Treatment:

Drug: 40mg KH607 tablets

KH607 Cohort 7

Experimental group

Description:

Subject received a single KH607 tablets dose of 50mg KH607 tablets or matching placebo.

Treatment:

Drug: 50mg KH607 tablets

KH607 Cohort 8

Experimental group

Description:

Subject received a single KH607 tablets dose of 60mg KH607 tablets or matching placebo.

Treatment:

Drug: 60mg KH607 tablets

KH607 Cohort 9

Experimental group

Description:

Subject received 10mg KH607 or matching placebo, oncely daily from Day 1 to Day 7.

Treatment:

Drug: 10mg KH607 tablets

KH607 Cohort 10

Experimental group

Description:

Subjects receive 20mg KH607 or matching placebo, once daily from Day 1 to Day 7.

Treatment:

Drug: 20mg KH607 tablets

KH607 Cohort 11

Experimental group

Description:

Subjects receive 30mg KH607 or matching placebo, once daily from Day 1 to Day 7.

Treatment:

Drug: 30mg KH607 tablets