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RECRUITINGPHASE1

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

NCT07240675•Hunan Kelun Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

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；

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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；
+14 more criteria

Locations (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

November 26, 2025

Primary Completion Date

September 30, 2026

Completion Date

September 30, 2026

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Healthy Volunteers

Interventions

pramipexole hydrochloride sustained-release tablets

DRUG

KLA478

DRUG

placebo

DRUG

Contacts

Wei Qi

CONTACT

028-82339360 qiw@kelun.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single-dose,First-in-human of KLA478

Inclusion Criteria

Exclusion Criteria

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