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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: pramipexole hydrochloride sustained-release tablets; Drug: KLA478; Drug: placebo

Detailed Description

This study is a single-center, randomized/non-randomized, single ascending dose（SAD）, Phase I clinical trial conducted in healthy subjects, divided into two parts:

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；

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wei Qi; Phone Number: 028-82339360; Email: qiw@kelun.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201107
      • Recruiting
      • Huashan Hospital Affiliated to Fudan University
      • Contact: Xiaojie Wu; Phone Number: 13524686330; Email: maomao_xj@163.com
      • Contact: Jing Zhang; Phone Number: 13816357098; Email: 13816357098@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pramipexole hydrochloride sustained-release tablets 0.375mg; 10 volunteers receive pramipexole hydrochloride sustained-release tablets 0.375mg	Drug: pramipexole hydrochloride sustained-release tablets; P.O., single dose
Experimental: KLA478 2mg; 8 volunteers receive KLA478 2mg，2 volunteers receive the same volume placebo	Drug: KLA478; intramuscular injection, single dose; Drug: placebo; intramuscular injection, single dose
Experimental: KLA478 5mg; 8 volunteers receive KLA478 5mg，2 volunteers receive the same volume placebo	Drug: KLA478; intramuscular injection, single dose; Drug: placebo; intramuscular injection, single dose
Experimental: KLA478 10mg; 8 volunteers receive KLA478 10mg，2 volunteers receive the same volume placebo	Drug: KLA478; intramuscular injection, single dose; Drug: placebo; intramuscular injection, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events (AEs)	Up to Day 109

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter Tmax	Time of Cmax (Tmax) after single dose	up to Day 90
PK parameter Cmax	Maximum peak plasma concentration (Cmax) after single dose	up to Day 90
PK parameter AUC0-t	Area under the concentration-time curve (AUC0-t) from time zero to time "t" after single dose	up to Day 90
PK parameter AUC0-∞	AUC from time zero to infinity (AUC0-∞) after single dose	up to Day 90
PK parameter AUC_%Extrap	Area Under the Curve Percent Extrapolated	up to Day 90
PK parameter Tlast	Time of Last measurable concentration	Area Under the Curve Percent Extrapolated
PK parameter λz	Elimination Rate Constant	up to Day 90
PK parameter t1/2	Terminal-phase elimination half-life (t1/2) after single dose	up to Day 90
PK parameter CL/F	Clearance adjusted for bioavailability	up to Day 90
PK parameter Vz/F	Volume of Distribution adjusted for bioavailability	up to Day 90
PK parameter MRT	Mean Resident Time	up to Day 90

Collaborators and Investigators

• Sponsor: Hunan Kelun Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Healthy
• Other Study ID Numbers: KLA478-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No