Actively Recruiting
A Single-center, Randomized, Double-blind, Placebo-Controlled, Dose Escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of KLA480 Injection in Healthy Chinese Adults
Led by Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. · Updated on 2025-06-22
20
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetic properties of a single subcutaneous injection of KLA480 in healthy adult participants aged 18 to 45 years. This phase I clinical trial is randomized, double-blind, placebo-controlled, and dose-escalation in design, involving healthy Chinese volunteers. The study aims to understand how the drug behaves in the body and its safety profile in this population. The trial includes two dose groups: one receiving 11.3 mg and the other 22.6 mg of KLA480 injection. Each group consists of 10 participants, with 8 receiving KLA480 and 2 receiving placebo injections. Participants are enrolled successively, starting with a sentinel group of three participants to assess initial tolerance before enrolling the remaining participants in each dose group. Participants will be monitored from the time of consent through 43 days after dosing to assess safety and tolerability, including vital signs, physical exams, lab tests, chest X-rays, and ECGs. Pharmacokinetic measures such as peak plasma concentration, time to peak concentration, and drug elimination half-life will also be collected. The study includes safety follow-up for up to 90 days after dosing to evaluate how the drug is processed and tolerated over time.
CONDITIONS
Brief Title
A Phase I Clinical Study of a Single Dose of KLA480
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must understand and agree to follow the study process and sign informed consent
- Healthy adults aged 18 to 45 years
- Men must weigh at least 50.0 kg; women must weigh at least 45.0 kg
- Body mass index (BMI) between 18.0 and 28.0 kg/m2
- Normal or clinically insignificant results on vital signs, physical exam, lab tests, chest X-ray, and ECG
- Fertile participants agree to use effective contraception and avoid donating sperm or eggs from consent until 3 months after last dose
You will not qualify if you...
- History of severe allergy to rotigotin or similar dopamine agonists
- History of significant gastrointestinal, renal, hepatic, neurological, hematologic, endocrine, tumor, pulmonary, immune, psychiatric, or cardio-cerebrovascular diseases
- History of unexplained orthostatic hypotension, syncope, or low systolic blood pressure
- Acute infection or other acute illness within 2 weeks before consent
- Unprotected sexual behavior within 2 weeks before consent
- Intolerance of venous puncture or history of fainting during blood draws
- Blood donation, major blood loss, or transfusion within 3 months before consent
- Recent or planned surgery affecting drug metabolism within specified timeframes
- Participation in other drug/device trials within 3 months before consent
- Vaccination within 1 month before consent or planned during study
- Use of strong/moderate liver enzyme inhibitors or inducers within 4 weeks before dosing
- Use of any prescription, over-the-counter, vitamin, or herbal medicines within 2 weeks before dosing
- Significant blood pressure changes during screening
- Prolonged QTcF interval (>450 ms) during screening
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Pregnancy or lactation
- History of drug abuse or positive drug tests within 6 months
- Heavy alcohol use or positive breath test
- Smoking more than 3 cigarettes per day recently or positive tobacco test
- Consumption of grapefruit or related products within 2 weeks before dosing
- Consumption of chocolate, caffeine, or certain foods within 72 hours before dosing
- Special dietary requirements incompatible with study diet
- Other investigator-determined factors making participant ineligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single subcutaneous injection of KLA480 or placebo to evaluate safety, tolerability, and pharmacokinetics.
1 dosing visit (in-person)
Duration - Up to 90 days
Participants are monitored for safety, tolerability, and pharmacokinetics for up to 90 days after dosing.
Multiple visits over 90 days for assessments
Trial Site Locations
Total: 1 location
1
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
W
Wei Qi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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