Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2025-11-26
2026-09-30
Brief Summary
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Detailed Description
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Part 1 is an open-label single-dose study of active comparator to evaluate the pharmacokinetic characteristics of active comparator in healthy subjects； Part 2 is a randomized, double-blind, placebo-controlled single ascending dose study of KLA478: The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single doses of KLA478 in healthy volunteers；
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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pramipexole hydrochloride sustained-release tablets 0.375mg
10 volunteers receive pramipexole hydrochloride sustained-release tablets 0.375mg
pramipexole hydrochloride sustained-release tablets
P.O., single dose
KLA478 2mg
8 volunteers receive KLA478 2mg，2 volunteers receive the same volume placebo
KLA478
intramuscular injection, single dose
placebo
intramuscular injection, single dose
KLA478 5mg
8 volunteers receive KLA478 5mg，2 volunteers receive the same volume placebo
KLA478
intramuscular injection, single dose
placebo
intramuscular injection, single dose
KLA478 10mg
8 volunteers receive KLA478 10mg，2 volunteers receive the same volume placebo
KLA478
intramuscular injection, single dose
placebo
intramuscular injection, single dose
Interventions
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pramipexole hydrochloride sustained-release tablets
P.O., single dose
KLA478
intramuscular injection, single dose
placebo
intramuscular injection, single dose
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
ALL
Yes
Sponsors
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Hunan Kelun Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KLA478-101
Identifier Type: -
Identifier Source: org_study_id
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