Menu
Recruiting NCT07240675

Single-dose,First-in-human of KLA478

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pramipexole hydrochloride sustained-release tablets, KLA478, placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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；

Interventions

  • Drug pramipexole hydrochloride sustained-release tablets
    P.O., single dose
  • Drug KLA478
    intramuscular injection, single dose
  • Drug placebo
    intramuscular injection, single dose

Primary outcome measures

  • Incidence and severity of adverse events (AEs) [Time frame: Up to Day 109]
Secondary outcome measures (11)
  • PK parameter Tmax [Time frame: up to Day 90]
  • PK parameter Cmax [Time frame: up to Day 90]
  • PK parameter AUC0-t [Time frame: up to Day 90]
  • PK parameter AUC0-∞ [Time frame: up to Day 90]
  • PK parameter AUC_%Extrap [Time frame: up to Day 90]
  • PK parameter Tlast [Time frame: Area Under the Curve Percent Extrapolated]
  • PK parameter λz [Time frame: up to Day 90]
  • PK parameter t1/2 [Time frame: up to Day 90]
  • PK parameter CL/F [Time frame: up to Day 90]
  • PK parameter Vz/F [Time frame: up to Day 90]
  • PK parameter MRT [Time frame: up to Day 90]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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；
  • Lactation or pregnancy test positive ；
  • History of any drug abuse or positive drugs of abuse test result；
  • Previous alcohol abuse or unwillingness to stop drinking or alcohol breath test positive；
  • more than 3 cigarettes per day in 3 months, or unwilling to stop during the trial；
  • Intake of special diets that affect drug absorption, distribution, metabolism and excretion within 48 hours；
  • Have special requirements for diet；
  • Unprotected sexual behavior within 2 weeks;
  • engaged in driving vehicles, operating machinery, high-altitude work or other potentially dangerous behavior;
  • Inappropriate for participation in this trial as judged by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Huashan Hospital Affiliated to Fudan University — Shanghai

Identifiers

NCT: NCT07240675 · KLA478-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗