Single-dose KLA318-2 nanocrystal injection safety and PK test

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KLA318-2 Nanocrystal Injection in Healthy Participants

This trial will try one intravenous dose of KLA318-2 in healthy adults to see if it is safe, tolerable, and how the body processes it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07171034 on ClinicalTrials.gov

What this trial studies

This Phase I, interventional study enrolls healthy volunteers aged 18–45 to receive a single intravenous injection of KLA318-2 nanocrystal and follow them for safety, tolerability, and pharmacokinetics. Staff will collect serial blood samples and monitor vital signs, ECG, and adverse events to characterize how the drug is absorbed, distributed, and cleared. The interventions list also includes a celecoxib (Celebrex) capsule, suggesting the protocol may include co-administration or interaction checks with celecoxib. Standard exclusion criteria (recent medications, surgeries, vaccines, substance use, or significant medical history) are applied to minimize risk and confounding factors.

Who should consider this trial

Good fit: Healthy adults 18–45 years old who meet the specified weight and BMI ranges, have normal ECG and no clinically significant medical history, and can tolerate venipuncture are ideal candidates.

Not a fit: People with significant medical conditions, recent surgery or medication/vaccine use, drug or alcohol abuse, known hypersensitivity to study drugs, heavy smokers, or those with difficult venous access are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the study could define a safe single-dose exposure and pharmacokinetic profile to support further clinical development of KLA318-2.

How similar studies have performed: Single-dose Phase I safety and PK trials in healthy volunteers are a routine first step and many nanocrystal formulations have progressed after similar positive results, but KLA318-2 itself appears untested in humans.

Eligibility criteria

Inclusion Criteria:

1. Health participants (Age: 18\~45 years);
2. Body Weight: Male≥50.0kg, Female≥45.0kg; 18.5 ≤BMI≤ 28.0;
3. Normal ECG, showing no clinically relevant deviations, as judged by the investigator.

Exclusion Criteria:

1. Allergy or Drug hypersensitivity;
2. Clinically significant Medical History;
3. Gastrointestinal ulcers or gastrointestinal bleeding;
4. History of any surgery within 4 weeks;
5. History of any Medication within 14 days;
6. History of any drug interactions with celecoxib within 30 days;
7. History of any clinical study within 3 months;
8. History of any vaccine within 1 month;
9. History of any drug abuse, or positive drugs of abuse test result;
10. Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia;
11. Massive blood loss (\> 200 mL) in the past 3 months;
12. Special requirements for diet;
13. Heavy smoker ( more than 3 cigarettes/day) within 3 months;
14. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months, or positive alcohol test;
15. Heavy caffeine intake;
16. History of grapefruit, xanthine-rich foods intake within 7 days;
17. Female participants are pregnant or lactating;
18. History of unprotected sex within 2 weeks.

Where this trial is running

Jinan, Shandong

• The first affiliated hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Wei Qi

Conditions Healthy Participants; Healthy