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.
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…