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

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.

NCT Number	NCT07409922
Lead Sponsor	Jiangxi Kvvit Pharmaceutical Co., Ltd.
Conditions	Healthy
Enrollment	92 participants
Start Date	2026-02-05
Primary Completion	2026-11-20 (estimated)
Study Completion	2026-11-20 (estimated)
Updated on ClinicalTrials.gov	2026-08-05