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NOT YET RECRUITING
NCT07409922
PHASE1

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

Sponsor: Jiangxi Kvvit Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2026-02-03

Completion Date

2026-11-20

Last Updated

2026-02-13

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

KR23343

Participants will recieve oral administrations of KR23343

DRUG

Matching Placebo

Participants will recieve placebo