NCT07044960

A Phase 1 Study of KHN702 Tablets in Healthy Subjects

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of KHN702 Tablets in Chinese Healthy Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, randomized, double-blind, placebo-controlled study divided into a Single Ascending Dose (SAD) stage and a Multiple Ascending Dose (MAD) phase. The primary objective is to evaluate the safety and tolerability of KHN702 tablets in Chinese healthy volunteers（HVs).

Detailed description

This study consists of two parts: Part 1-SAD phase and Part 2- MAD phase. There will be 7 cohorts in Part 1 and 3 cohorts in Part 2. The SAD study will enroll approximately 54 HVs across 7 dose cohorts. All participants in Part 1 will be administered with a single oral dose of KHN702 or its matching placebo under fasted condition. Approximately 30 HVs will be enrolled in the multiple ascending dose study. All participants in Part 2 will received KHN702 or placebo once daily for continuous 7 days (QD x 7d) in a double-blind manner. The safety and tolerability will be evaluated by monitoring and assessment of AEs, clinical laboratory tests (hematology, urinalysis, biochemistry, coagulation, etc.), physical examination findings, etc.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	KHN702 tablet or placebo	Subject will receive a single KHN702 tablet or matching placebo orally in fasted state.
DRUG	KHN702 tablet or placebo	All participants will receive KHN702 tablet or matching placebo orally once a day for 7 days in fasted state.

Timeline

• Start date: 2025-06-21
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-07-01
• Last updated: 2025-07-01