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RecruitingNCT07240675Updated May 26, 2026

Single-dose,First-in-human of KLA478

A Phase 1 interventional study of pramipexole hydrochloride sustained-release tablets and KLA478 in Healthy Volunteers, sponsored by Hunan Kelun Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Hunan Kelun Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

Read the 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；

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Healthy
03

In context

Lead sponsor

Hunan Kelun Pharmaceutical Co., Ltd. is the lead sponsor of 8 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • Experimental
    KLA478 2mg

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

    Drug: KLA478 · Drug: placebo

  • Experimental
    KLA478 5mg

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

    Drug: KLA478 · Drug: placebo

  • Experimental
    KLA478 10mg

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

    Drug: KLA478 · Drug: placebo

Interventions

  • Drugpramipexole hydrochloride sustained-release tablets

    P.O., single dose

  • DrugKLA478

    intramuscular injection, single dose

  • Drugplacebo

    intramuscular injection, single dose

06

What researchers measure

Primary outcomes

  1. Incidence and severity of adverse events (AEs)

    Time frame: Up to Day 109

Secondary outcomes

  1. PK parameter Tmax

    Time of Cmax (Tmax) after single dose

    Time frame: up to Day 90

  2. PK parameter Cmax

    Maximum peak plasma concentration (Cmax) after single dose

    Time frame: up to Day 90

  3. PK parameter AUC0-t

    Area under the concentration-time curve (AUC0-t) from time zero to time "t" after single dose

    Time frame: up to Day 90

  4. PK parameter AUC0-∞

    AUC from time zero to infinity (AUC0-∞) after single dose

    Time frame: up to Day 90

  5. PK parameter AUC_%Extrap

    Area Under the Curve Percent Extrapolated

    Time frame: up to Day 90

  6. PK parameter Tlast

    Time of Last measurable concentration

    Time frame: Area Under the Curve Percent Extrapolated

  7. PK parameter λz

    Elimination Rate Constant

    Time frame: up to Day 90

  8. PK parameter t1/2

    Terminal-phase elimination half-life (t1/2) after single dose

    Time frame: up to Day 90

  9. PK parameter CL/F

    Clearance adjusted for bioavailability

    Time frame: up to Day 90

  10. PK parameter Vz/F

    Volume of Distribution adjusted for bioavailability

    Time frame: up to Day 90

  11. PK parameter MRT

    Mean Resident Time

    Time frame: up to Day 90

07

Study locations

1 of 1 sites recruiting
  • Huashan Hospital Affiliated to Fudan University
    Shanghai, Shanghai Municipality 201107, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07240675
Lead sponsor
Hunan Kelun Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Nov 21, 2025
Start date
Nov 26, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
May 26, 2026

Study contacts

Wei Qi
Contact
qiw@kelun.com
028-82339360

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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