Actively Recruiting
A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KLA318-2 Nanocrystal Injection in Healthy Participants
Led by Hunan Kelun Pharmaceutical Co., Ltd. · Updated on 2026-05-26
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes KLA318-2 Nanocrystal Injection after a single intravenous dose in healthy adults aged 18 to 45 years. This Phase I study involves healthy volunteers and aims to understand the drug's effects and behavior in the body compared to Celebrex capsules at different doses. Participants will receive varying doses of KLA318-2 (60mg, 120mg, 180mg, or 240mg) as a single intravenous injection. Some participants will alternate between KLA318-2 and Celebrex capsules in two periods to compare treatments. Celebrex is given orally at doses of 200mg or 400mg. The study is non-randomized and open-label, with no masking. Participants will be monitored for up to 14 days after dosing to track any adverse events. Researchers will measure drug levels and pharmacokinetic parameters such as peak concentration, time to peak, area under the curve, and half-life up to day 3. Safety checks include ECGs and assessments of tolerability. The study involves one dosing visit and follow-up assessments over two weeks.
CONDITIONS
Brief 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 body weight at least 50.0 kg, female 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 hypersensitivity to drugs
- Clinically significant medical history
- Gastrointestinal ulcers or bleeding
- Surgery within the past 4 weeks
- Medication use within the past 14 days
- Drug interactions with celecoxib within the past 30 days
- Participation in clinical studies within the past 3 months
- Vaccination within the past 1 month
- History of drug abuse or positive drug test
- Difficulty with venous blood collection or history of needle/blood phobia
- Massive blood loss (>200 mL) in the past 3 months
- Special dietary requirements
- Heavy smoking (>3 cigarettes/day) within the past 3 months
- History of alcohol abuse or heavy intake (>14 units/week) within 6 months or positive alcohol test
- Heavy caffeine intake
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants receive a single intravenous injection of KLA318-2 Nanocrystal or a single oral dose of Celebrex Capsule depending on the dosing period and group assignment.
Up to 3 visits for dosing and assessments
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
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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