drugset
drugset / Trial / NCT07409922

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

NCT07409922 ↗

Phase 1 Not yet recruiting 92 enrolled Jiangxi Kvvit Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2026-02-03
Primary completion
2026-11-20
Completion
2026-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject KR23343 Unknown 10 mg Oral
Subject KR23343 Unknown 20 mg Oral
Subject KR23343 Unknown 30 mg Oral
Subject KR23343 Unknown 45 mg Oral
Subject KR23343 Unknown 60 mg Oral

Indications

No indication recorded.