Single-dose,First-in-human of KLA478

NCT07240675 | Recruiting Phase 1

• 1 other identifier: KLA478-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs)

  Up to Day 109

Secondary Outcomes (11)

• PK parameter Tmax

  up to Day 90

• PK parameter Cmax

  up to Day 90

• PK parameter AUC0-t

  up to Day 90

• PK parameter AUC0-∞

  up to Day 90

• PK parameter AUC_%Extrap

  up to Day 90

Study Arms (4)

pramipexole hydrochloride sustained-release tablets 0.375mg

ACTIVE COMPARATOR

10 volunteers receive pramipexole hydrochloride sustained-release tablets 0.375mg

Drug: pramipexole hydrochloride sustained-release tablets

KLA478 2mg

EXPERIMENTAL

8 volunteers receive KLA478 2mg，2 volunteers receive the same volume placebo

Drug: KLA478; Drug: placebo

KLA478 5mg

EXPERIMENTAL

8 volunteers receive KLA478 5mg，2 volunteers receive the same volume placebo

Drug: KLA478; Drug: placebo

KLA478 10mg

EXPERIMENTAL

8 volunteers receive KLA478 10mg，2 volunteers receive the same volume placebo

Drug: KLA478; Drug: placebo

Interventions

pramipexole hydrochloride sustained-release tablets DRUG

P.O., single dose

pramipexole hydrochloride sustained-release tablets 0.375mg

KLA478 DRUG

intramuscular injection, single dose

KLA478 10mg; KLA478 2mg; KLA478 5mg

placebo DRUG

intramuscular injection, single dose

KLA478 10mg; KLA478 2mg; KLA478 5mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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；

Sponsors & Collaborators

• Hunan Kelun Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 201107, China

RECRUITING

Central Study Contacts

Wei Qi

CONTACT

028-82339360; qiw@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 21, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)