NCT07409922

Study of Single and Multiple Ascending Doses of KR23343 in Healthy Adult Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KR23343, and an Open-Label Assessment of Food's Effect on Its Pharmacokinetics in Healthy Adults

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Jiangxi Kvvit Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, single-center trial to assess the safety, tolerability, PK and food effect of KR23343 in healthy volunteers. The study will be conducted in 3 sequential stages: Stage 1: Single-Ascending-Dose (SAD) study A randomized, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability, and PK of single ascending doses of KR23343. Stage 2: Food-Effect (FE) study An open-label, randomized, two-period, two-sequence crossover study to evaluate the effect of food on the PK of a single dose of KR23343. Stage 3: Multiple-Ascending-Dose (MAD) study A randomized, double-blind, placebo-controlled, dose-escalation study to investigate the safety, tolerability, and PK of repeated once-daily administration of KR23343 for 10 days.

Detailed description

This first-in-human study will investigate the safety, tolerability, and pharmacokinetics (PK) of KR23343 following single and multiple ascending oral doses in healthy subjects, as well as assess the effect of food on the PK of KR23343. The results of this study will be used to select doses for subsequent studies in patients. Primary objectives: Stage 1: To assess the safety and tolerability of single ascending oral doses of KR23343 in healthy participants. Stage 3: To assess the safety and tolerability of multiple ascending oral doses of KR23343 in healthy participants. Secondary objectives: Stage 1: To assess the PK profile of KR23343 following single oral doses in healthy participants and evaluate the effect of KR23343 tablets on the corrected QT interval (QTcF) and other electrocardiogram (ECG) parameters. Stage 2: To assess the PK profile, safety and tolerability of a single dose of KR23343 following high-fat food intake relative to fasting conditions in healthy participants. Stage 3: To assess the PK profile of KR23343 after repeated oral doses in healthy participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	KR23343	Participants will recieve oral administrations of KR23343
DRUG	Matching Placebo	Participants will recieve placebo

Timeline

• Start date: 2026-02-03
• Primary completion: 2026-11-20
• Completion: 2026-11-20
• First posted: 2026-02-13
• Last updated: 2026-02-13