Clinical Trials in China / NCT07240675
Recruiting
Phase 1
Single-dose,First-in-human of KLA478
NCT07240675 · tracked via the Priya Life Science China tracker
Condition(s) studied
Healthy Volunteers
Investigational drug(s) / intervention(s)
pramipexole hydrochloride sustained-release tabletsKLA478placebo
pramipexole hydrochloride sustained-release tablets: P.O., single dose
KLA478: intramuscular injection, single dose
placebo: intramuscular injection, single dose
Study summary
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single doses of KLA478 in healthy volunteers;
Eligibility
Inclusion Criteria:
1. Sign the informed consent form
2. Health participants (Age: 18\~45 years);
3. Body Weight: Male≥50.0kg, Female≥45.0kg; 19 ≤BMI≤ 28.0kg/m2;
4. Clinical examination normal, or abnormal with no clinical significance;
5. Agreed to use contraception for 3-6 months.
Exclusion Criteria:
1. Allergy or Drug hypersensitivity;
2. Clinically significant Medical History;
3. Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia;
4. Assess injection site abnormalities;
5. History of drugs that may interact with pramipexole within 1 month;
6. History of any Medication within 2 weeks;
7. Massive blood loss (\> 200 mL) in the past 3 months;
8. History of any surgery within 3 months, or plan to undergo surgery during the trial;
9. History of any clinical study within 90 days;
10. History of any vaccine within 1 month,or Plan to get vaccinated during the trial period;
11. systolic blood pressure decreased ≥20 mmHg or diastolic blood pressure decreased ≥10 mmHg within 3 minutes from supine to upright position;
12. QTcF\>450 ms;
13. Abnormal vital signs with clinical significance ;
14. Serum potassium level exceeds the reference range.;
15. Pre-transfusion test abnormal;
16. Lactation or pregnancy test positive ;
17. History of any drug abuse or positive drugs of abuse test result;
18. Previous alcohol abuse or unwillingness to stop drinking or alcohol breath test positive;
19. more than 3 cigarettes per day in 3 months, or unwilling to stop during the trial;
20. Intake of special diets that affect drug absorption, distribution, metabolism and excretion within 48 hours;
21. Have special requirements for diet;
22. Unprotected sexual behavior within 2 weeks;
23. engaged in driving vehicles, operating machinery, high-altitude work or other potentially dangerous behavior;
24. Inappropriate for participation in this trial as judged by the investigator.
Primary outcome measure(s)
- Incidence and severity of adverse events (AEs) — Up to Day 109
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | Recruiting |
More Hunan Kelun Pharmaceutical Co., Ltd. trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07240675 on ClinicalTrials.gov ↗ ← All trials in China