RecruitingPhase 1NCT07240675
Single-dose,First-in-human of KLA478
A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Doses of KLA478 in Healthy Volunteers
Sponsor
Hunan Kelun Pharmaceutical Co., Ltd.
Enrollment
40 participants
Start Date
Nov 26, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single doses of KLA478 in healthy volunteers;
Eligibility
Min Age: 18 YearsMax Age: 45 Years
Inclusion Criteria5
- Sign the informed consent form
- Health participants (Age: 18~45 years);
- Body Weight: Male≥50.0kg, Female≥45.0kg; 19 ≤BMI≤ 28.0kg/m2;
- Clinical examination normal, or abnormal with no clinical significance;
- Agreed to use contraception for 3-6 months.
Exclusion Criteria24
- Allergy or Drug hypersensitivity;
- Clinically significant Medical History;
- Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia;
- Assess injection site abnormalities;
- History of drugs that may interact with pramipexole within 1 month;
- History of any Medication within 2 weeks;
- Massive blood loss (> 200 mL) in the past 3 months;
- History of any surgery within 3 months, or plan to undergo surgery during the trial;
- History of any clinical study within 90 days;
- History of any vaccine within 1 month,or Plan to get vaccinated during the trial period;
- systolic blood pressure decreased ≥20 mmHg or diastolic blood pressure decreased ≥10 mmHg within 3 minutes from supine to upright position;
- QTcF>450 ms;
- Abnormal vital signs with clinical significance ;
- Serum potassium level exceeds the reference range.;
- Pre-transfusion test abnormal;
- Lactation or pregnancy test positive ;
- History of any drug abuse or positive drugs of abuse test result;
- Previous alcohol abuse or unwillingness to stop drinking or alcohol breath test positive;
- more than 3 cigarettes per day in 3 months, or unwilling to stop during the trial;
- Intake of special diets that affect drug absorption, distribution, metabolism and excretion within 48 hours;
- Have special requirements for diet;
- Unprotected sexual behavior within 2 weeks;
- engaged in driving vehicles, operating machinery, high-altitude work or other potentially dangerous behavior;
- Inappropriate for participation in this trial as judged by the investigator.
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Interventions
DRUGpramipexole hydrochloride sustained-release tablets
P.O., single dose
DRUGKLA478
intramuscular injection, single dose
DRUGplacebo
intramuscular injection, single dose
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07240675
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