A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of KH607 in Healthy Chinese Participants

A Randomized, Open-Label, 2-period, 2-sequence, Crossover Food-Effect Study of KH607 Tablets in Healthy Chinese Participants

This study is a randomized, open-label, 2-period, 2-sequence, crossover food-effect study designed to evaluate the effect of a high-fat meal on the pharmacokinetics of a single oral dose of KH607 tablets in healthy participants, as well as to assess the safety of a single oral dose of KH607 tablets administered under fasting and fed conditions in healthy participants.

Study Overview

• Status: Not yet recruiting
• Conditions: Food Effect of KH607 in Chinese Health Participants
• Intervention / Treatment: Drug: KH607

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chang Meng Yang, Medical Doctor; Phone Number: 86-28-87393401; Email: ymc681@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Participants must be healthy and aged ≥18 and <45 years at the time of screening visit.
2. Participants must have a body weight equal to or greater than 50 kg (≧45 kg for females ) and a body mass index between 19.0 kg/m2 and 28.0 kg/m2 at the time of screening visit.
3. Participants who have no plans for reproduction during the study period and for 3 months following the last dose, must voluntarily agree to use effective and appropriate contraceptive measures, and must have no plans for sperm or egg donation during this period.
4. Participant who can understand and comply with the study procedures and requirements, and can provide written informed consent prior to any study procedures shall be included

Exclusion Criteria:

1. Participants with known allergy to any ingredient of KH607; or those with a known history of allergy to drugs of the same class; or those with known allergies to two or more other drugs, foods, or environmental factors; or those known to be prone to allergic symptoms such as rash, urticaria, etc. shall be excluded.
2. Participants with diseases of the cardiovascular, nervous, respiratory, urinary, digestive, hematologic, endocrine, or immune systems, or psychiatric disorders (including but not limited to: history of epilepsy, Parkinson's disease or other movement disorders, clinically significant history of syncope or vertigo, and any history of psychiatric disorders), which may affect the safety evaluation of the trial, and who, in the opinion of the investigator, are unsuitable for participation in the trial.
3. Participants with a history of vestibular dysfunction or severe motion sickness; or a history of ocular disorders such as glaucoma, retinopathy, or other ophthalmic diseases that may cause blurred vision or exacerbate visual adverse effects and are considered clinically significant by the investigator shall be excluded.
4. Participants who are unable to Irefrain from driving vehicles, operating hazardous machinery, or working at heights from the time of signing the informed consent form until 1 week after the last dose shall be excluded.
5. Participation who have participated in another clinical trial and received an investigational drug, vaccine, or device within 90 days prior to the first dose shall be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A: KH607; period 1: Fasted, Period 2: Fed	Drug: KH607; KH607, single dose, oral
Experimental: Sequence B: KH607; period 1: Fed, Period 2: Fasted	Drug: KH607; KH607, single dose, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC0-t	Up to 96 Hours after study drug administration
AUC0-∞	Up to 96 Hours after study drug administration
Cmax	Up to 96 Hours after study drug administration
The GMRs and their 90% confidence intervals for AUC0-∞ (or AUC0-t and Cₘₐₓ of KH607 tablets under fasting and fed conditions )	Up to 96 Hours after study drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Tmax	Up to 96 Hours after study drug administration
t1/2	Up to 96 Hours after study drug administration
λz	Up to 96 Hours after study drug administration
tlag	Up to 96 Hours after study drug administration
CL/F	Up to 96 Hours after study drug administration
Safety：Incidence and severity of Adverse Events ( AE)/SAE	from ICF signing date to day 19 since first dose

Collaborators and Investigators

• Sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KH607-30104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No