First human single and multiple dose KLA578-1 injections

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of KLA578-1 for Injection in Healthy Volunteers

This test will try single and multiple doses of KLA578-1 injections in healthy adults to see if the drug is safe and to measure 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 (Changsha, Hunan)
• Trial ID: NCT07143318 on ClinicalTrials.gov

What this trial studies

The study enrolls healthy volunteers in two parts to measure safety, tolerability, and pharmacokinetics of KLA578-1. Part 1 is an open-label single ascending dose escalation with three dose groups of 12 volunteers each, where groups 1 and 3 receive only KLA578-1 and group 2 is a randomized two‑period crossover comparing KLA578-1 with etocoxib tablets separated by a 7‑day washout. Part 2 is an open-label, single‑arm multiple‑dose cohort of 12 volunteers who receive 120 mg KLA578-1 once daily for five days under fasting conditions. Serial blood sampling, safety monitoring, and ECGs are used to characterize pharmacokinetics and tolerability.

Who should consider this trial

Good fit: Healthy adults aged 18–45 years with BMI 19.0–26.0 and minimum body weight (men ≥50 kg, women ≥45 kg) with no clinically significant medical history or abnormal labs are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have significant medical conditions, recent surgery or medication use, a history of drug allergy or abuse, tablet/needle intolerance, or recent participation in other clinical studies are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, the results could identify safe dosing ranges and pharmacokinetic profiles that enable later patient trials of KLA578-1.

How similar studies have performed: This is a first‑in‑human trial for KLA578-1 so the compound is novel, although similar first‑in‑human PK/safety designs have been successful for other injectable drugs.

Eligibility criteria

Inclusion Criteria:

1. Health Volunteers (Age: 18\~45 years);
2. Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 26.0;
3. There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, laboratory tests;
4. Heart rate ≥ 60 bpm and pulse ≥ 60 beats/min.

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 inducers or inhibitors of major CYP450 enzymes 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;
10. Tablet dysphagia;
11. Needle sickness, Hematosickness;
12. Massive blood loss (\> 200 mL) in the past 3 months;
13. Female volunteers are pregnant or lactating;
14. History of unprotected sex within 2 weeks;
15. Special requirements for diet;
16. Heavy smoker ( more than 3 cigarettes/day) within 3 months;
17. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months;
18. Heavy caffeine intake;
19. History of grapefruit, xanthine-rich foods intake within 7 days;
20. Positive alcohol test;
21. Positive drugs of abuse test result.

Where this trial is running

Changsha, Hunan

• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Wei Qi

Conditions Healthy Volunteers; Healthy