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

NCT07409922 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

KR23343

Participants will recieve oral administrations of KR23343

DRUG

Matching Placebo

Participants will recieve placebo

Sponsors & Collaborators

  • Jiangxi Kvvit Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07409922 on ClinicalTrials.gov