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

Recruiting Phase 1 Interventional Study
Healthy
Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 45
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
92 (estimated)
Sponsor
Jiangxi Kvvit Pharmaceutical Co., Ltd. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Healthy male or female participants aged 18 to 45 years, inclusive. 2. Body mass index (BMI) between 19 and 28 kg/m² (inclusive) and body weight ≥ 50 kg for males or ≥45 kg for females. 3. All screening assessments (vital signs, physical examination, laboratory tests, ECG) mu…
Contacts

Jing Zhang

021-52887926

zhangj_fudan@163.com

CONTACT

Peimin Yu

021-52888158

CONTACT