NCT07171034 A Phase I Study of KLA318-2 Nanocrystal Injection
| NCT ID | NCT07171034 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hunan Kelun Pharmaceutical Co., Ltd. |
| Condition | Healthy Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2025-09-01 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07171034 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Healthy Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07171034 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07171034 currently recruiting?
Yes, NCT07171034 is actively recruiting participants. Contact the research team at qiw@kelun.com for enrollment information.
Where is the NCT07171034 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT07171034 clinical trial?
NCT07171034 is sponsored by Hunan Kelun Pharmaceutical Co., Ltd.. The trial plans to enroll 48 participants.