Actively Recruiting
A Phase I Study of KLA318-2 Nanocrystal Injection
Led by Hunan Kelun Pharmaceutical Co., Ltd. · Updated on 2025-11-17
48
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety,tolerability and pharmacokinetics properties of KLA318-2 Nanocrystal Injection after a single intravenous injection in healthy participants.
CONDITIONS
Official Title
A Phase I Study of KLA318-2 Nanocrystal Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy participants aged 18 to 45 years
- Male participants with body weight at least 50.0 kg; female participants with body weight at least 45.0 kg
- Body Mass Index (BMI) between 18.5 and 28.0
- Normal ECG with no clinically relevant deviations as judged by the investigator
You will not qualify if you...
- Allergy or drug hypersensitivity
- Clinically significant medical history
- Gastrointestinal ulcers or gastrointestinal bleeding
- History of any surgery within 4 weeks
- History of any medication use within 14 days
- History of drug interactions with celecoxib within 30 days
- Participation in any clinical study within 3 months
- History of any vaccine within 1 month
- History of drug abuse or positive drug abuse test
- Difficult venous blood collection, intolerance to venipuncture, or history of needle/blood phobia
- Massive blood loss (> 200 mL) in the past 3 months
- Special diet requirements
- Heavy smoking (more than 3 cigarettes/day) within 3 months
- History of alcohol abuse, heavy alcohol intake (more than 14 units/week) within 6 months, or positive alcohol test
- Heavy caffeine intake
- Recent intake of grapefruit or xanthine-rich foods within 7 days
- Female participants who are pregnant or lactating
- History of unprotected sex within 2 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, China, 250014
Actively Recruiting
Research Team
W
Wei Qi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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