First-in-human single-dose KLA478 in healthy adults

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Doses of KLA478 in Healthy Volunteers

This study will test single doses of KLA478 in healthy adults to see if the drug is safe, tolerable, and how the body processes it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07240675 on ClinicalTrials.gov

What this trial studies

This single-center Phase 1 trial enrolls healthy volunteers in two parts: an open-label single-dose active-comparator arm to characterize the comparator's pharmacokinetics, followed by a randomized, double-blind, placebo-controlled single ascending dose (SAD) arm of KLA478. Participants are healthy adults aged 18–45 who meet weight and BMI criteria and undergo screening labs and clinical exams. Doses of KLA478 will be escalated across cohorts with close safety monitoring and serial blood sampling for pharmacokinetic analysis. The study collects safety, tolerability, and PK data to inform dosing for later-phase studies.

Who should consider this trial

Good fit: Ideal participants are healthy adults aged 18–45 with BMI 19–28 and minimum weight requirements who have no significant medical history and agree to the study procedures and contraception requirements.

Not a fit: People with significant medical conditions, drug allergies, recent medication or vaccine use, difficult venous access, pregnancy, or those planning surgery are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the trial could identify a safe single dose and provide pharmacokinetic data to guide future patient studies of KLA478.

How similar studies have performed: Single ascending-dose first-in-human studies are a standard approach that have successfully defined safety and PK for many new drugs, but KLA478 itself is novel and untested in humans.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: Wei Qi

Conditions Healthy Volunteers; Healthy