Actively Recruiting
Phase 1 Study of KH607 Tablets
Led by Chengdu Kanghong Pharmaceutical Group Co., Ltd. · Updated on 2024-05-07
88
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was a single-center, randomized, double-blind, placebo-controlled study divided into a Single Ascending Dose (SAD) stage and a Multiple Ascending Dose (MAD) stage. The primary objective was to evaluate the safety and tolerability of KH607 tablets in Chinese healthy volunteers.
CONDITIONS
Official Title
Phase 1 Study of KH607 Tablets
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male and female volunteers aged 18 to 55 years
- Male weight at least 50 kg, female weight at least 45 kg
- Body mass index between 19 and 28 kg/m2 at screening
You will not qualify if you...
- Investigator or their immediate family members or individuals under coercion
- Risk for suicide or history of suicidal or self-harming behavior
- Stanford Sleepiness Scale score of 3 or higher or Modified Observer's Assessment of Alertness/Sedation score of 4 or lower at screening
- History of gastrointestinal surgery or current gastrointestinal disorders affecting drug absorption
- Major surgery within 3 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Anding Hospital Affiliated to Capital Medical University
Beijing, China
Actively Recruiting
Research Team
L
Ling Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
11
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