First human single and multiple dose KLA578-1 injections
Official title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of KLA578-1 for Injection in Healthy Volunteers
Run by Hunan Kelun Pharmaceutical Co., Ltd. · NCT07143318 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Hunan Kelun Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Changsha, Hunan) |
| Status | Recruiting |
| Started | June 5, 2025 |
| Main results expected | May 31, 2026 |
| Study ends | May 31, 2026 |
| Registry record updated | May 26, 2026 |
| Trial ID | NCT07143318 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China Recruiting
Study contacts
- Study coordinator: Wei Qi
- Email: qiw@kelun.com
- Phone: 028-82339360
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.