A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Doses of KLA478 in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Incidence and severity of adverse events (AEs)
Study Overview
Brief 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；
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
KLA478 5mg
8 volunteers receive KLA478 5mg，2 volunteers receive the same volume placebo
Intervention: KLA478 (Drug)
KLA478 2mg
8 volunteers receive KLA478 2mg，2 volunteers receive the same volume placebo
Intervention: KLA478 (Drug)
KLA478 5mg
8 volunteers receive KLA478 5mg，2 volunteers receive the same volume placebo
Intervention: placebo (Drug)
KLA478 10mg
8 volunteers receive KLA478 10mg，2 volunteers receive the same volume placebo
Intervention: KLA478 (Drug)
KLA478 10mg
8 volunteers receive KLA478 10mg，2 volunteers receive the same volume placebo
Intervention: placebo (Drug)
pramipexole hydrochloride sustained-release tablets 0.375mg
10 volunteers receive pramipexole hydrochloride sustained-release tablets 0.375mg
Intervention: pramipexole hydrochloride sustained-release tablets (Drug)
KLA478 2mg
8 volunteers receive KLA478 2mg，2 volunteers receive the same volume placebo
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Incidence and severity of adverse events (AEs)
Time Frame: Up to Day 109
Secondary Outcomes
- 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)
- PK parameter Tlast(Area Under the Curve Percent Extrapolated)
- PK parameter λz(up to Day 90)
- PK parameter t1/2(up to Day 90)
- PK parameter CL/F(up to Day 90)
- PK parameter Vz/F(up to Day 90)
- PK parameter MRT(up to Day 90)