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
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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
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.
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