Single-dose,First-in-human of KLA478

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single doses of KLA478 in healthy volunteers；

Key facts

Study ID

NCT07240675

Run by

Hunan Kelun Pharmaceutical Co., Ltd.

People needed

40

Starts

2025-11-26

Expected to finish

2026-09-30

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Huashan Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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