Actively Recruiting
A Phase I Clinical Study of a Single Dose of KLA480
Led by Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. · Updated on 2025-06-22
20
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary purpose: To evaluate the safety and tolerability of KLA480 injection after a single subcutaneous injection in healthy participants. Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of KLA480 injection after a single subcutaneous injection in healthy participants.
CONDITIONS
Official 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
- Body weight at least 50 kg for men and 45 kg for women; BMI between 18.0 and 28.0 kg/m2
- Normal or clinically insignificant vital signs, physical exam, lab tests, chest X-ray, and ECG
- Participants of potential fertility agree to effective contraception during the study and for 3 months after last dose
You will not qualify if you...
- History of severe allergy to rotigotin or related dopamine agonists
- History of significant gastrointestinal, renal, liver, neurological, blood, endocrine, tumor, lung, immune, psychiatric, or heart diseases
- History of unexplained low blood pressure, fainting, or syncope
- Recent acute infection or illness within 2 weeks before consent
- Unprotected sexual activity within 2 weeks before consent
- Inability to tolerate blood draws or history of fainting during blood draws
- Blood donation, massive blood loss, or transfusion within 3 months before consent
- Recent or planned surgery affecting drug absorption/metabolism
- 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 medications, vitamins, or herbal products within 2 weeks before dosing
- Significant blood pressure drop upon standing or low baseline blood pressure
- QTcF interval above 450 ms during screening
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Pregnant or breastfeeding females
- History of drug abuse or positive drug screening within 6 months
- Heavy drinking or inability to abstain from alcohol during study
- Smoking more than 3 cigarettes daily within 3 months before consent or inability to stop during study
- Consumption of grapefruit products within 2 weeks before dosing
- Consumption of caffeine, chocolate, or certain foods within 72 hours before dosing
- Special dietary requirements preventing uniform diet during hospitalization
- Any other factors deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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