Actively Recruiting
A Pharmacokinetic Study of YN001 in Healthy Participants
Led by Beijing Inno Medicine Co., Ltd. · Updated on 2025-12-18
24
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1, single-center, open-label study designed to evaluate the pharmacokinetics (PK), safety, and immunogenicity following a single dose administration in healthy adult volunteers.
CONDITIONS
Official Title
A Pharmacokinetic Study of YN001 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent before any assessments
- Healthy male or female adults aged 18 to 65 years inclusive
- Good health confirmed by medical history, physical exam, vital signs, ECG, and lab tests at screening and baseline
- Vital signs within specified ranges: body temperature 35.5-37.7 °C, systolic BP 90-140 mm Hg, diastolic BP 40-95 mm Hg, pulse rate 40-100 bpm
- Body weight at least 50 kg and BMI between 18-32 kg/m2 at screening and baseline
- Meets contraception requirements
- Willing and able to comply with study requirements and restrictions
You will not qualify if you...
- Received an investigational agent within 30 days or 5 half-lives prior to dosing
- Used prescription drugs, OTC medication, herbal or dietary supplements, or vaccines within two weeks prior to dosing unless approved
- Fasting triglycerides above 2.8 mmol/L at screening or baseline
- History or presence of significant ECG abnormalities
- Pregnant or nursing women
- Use of more than 5 cigarettes or nicotine products per week or unwillingness to abstain from such products 7 days prior through Day 15
- History of drug or alcohol abuse within 12 months or positive drug/alcohol tests at screening or baseline
- Positive hepatitis B, hepatitis C, or HIV tests at screening
- History or susceptibility to muscle disorders or myopathy
- Multiple drug allergies or allergic reactions to study drug components
- Blood donation or loss over 400 ml within 3 months prior to dosing
- Plasma donation over 100 ml within 60 days prior to dosing
- Hemoglobin levels below 120 g/L at screening or baseline
- Recent or recurrent autonomic dysfunction or bronchospastic disease within 3 years
- History of significant food allergies (excluding mild lactose or glucose intolerance)
- Medical or surgical conditions affecting drug metabolism or safety judged by investigator
- Significant illness resolved within 2 weeks prior to dosing
- Any other condition or circumstance that may affect study compliance or safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CMAX Clinical Research
Adelaide, South Australia, Australia
Actively Recruiting
Research Team
K
Kerry Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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