Recruiting NCT07171034
A Phase I Study of KLA318-2 Nanocrystal Injection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KLA318-2 Nanocrystal Injection, Celebrex Capsule.
- Who it may be relevant to
- Registry conditions: Healthy Participants. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KLA318-2 Nanocrystal Injection in Healthy Participants
Overview
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.
Interventions
- Drug KLA318-2 Nanocrystal Injection
Intravenous injection, single dose - Drug Celebrex Capsule
P.O., single dose
Primary outcome measures
- Incidence and severity of adverse events (AEs) [Time frame: UP to Day 14]
Secondary outcome measures (5)
- PK parameter Cmax [Time frame: UP to Day 3]
- PK parameter Tmax [Time frame: UP to Day 3]
- PK parameter AUC0-t [Time frame: UP to Day 3]
- PK parameter AUC0-∞ [Time frame: UP to Day 3]
- PK parameter t1/2 [Time frame: UP to Day 3]
Eligibility criteria
Inclusion criteria
- Health participants (Age: 18\~45 years);
- Body Weight: Male≥50.0kg, Female≥45.0kg; 18.5 ≤BMI≤ 28.0;
- Normal ECG, showing no clinically relevant deviations, as judged by the investigator.
Exclusion criteria
- Allergy or Drug hypersensitivity;
- Clinically significant Medical History;
- Gastrointestinal ulcers or gastrointestinal bleeding;
- History of any surgery within 4 weeks;
- History of any Medication within 14 days;
- History of any drug interactions with celecoxib within 30 days;
- History of any clinical study within 3 months;
- History of any vaccine within 1 month;
- History of any drug abuse, or positive drugs of abuse test result;
- Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia;
- Massive blood loss (> 200 mL) in the past 3 months;
- Special requirements for diet;
- Heavy smoker ( more than 3 cigarettes/day) within 3 months;
- History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months, or positive alcohol test;
- Heavy caffeine intake;
- History of grapefruit, xanthine-rich foods intake within 7 days;
- Female participants are pregnant or lactating;
- History of unprotected sex within 2 weeks.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The first affiliated hospital of Shandong First Medical University (Shandong Provincial Qi — Jinan
Identifiers
NCT: NCT07171034 · KLA318-2-101