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
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1, open-label study to evaluate how the drug YN001 behaves in the body, its safety, and immune response after a single dose in healthy adult volunteers. The study aims to refine the pharmacokinetic profile of YN001 to support its further clinical development. About 24 healthy male and female participants aged 18 to 65 will take part in this research. Participants will be divided into two groups, each receiving a single intravenous infusion of YN001 at either 20 mg or 40 mg. The study includes a maximum 27-day screening period, a baseline day before dosing, the treatment day when the drug is administered, and a follow-up period lasting up to 15 days. After assessments on Day 8, participants will have a final phone visit on Day 15. During the study, participants will undergo various health checks including vital signs, electrocardiograms, laboratory tests, and physical exams. Researchers will measure multiple pharmacokinetic parameters of YN001 such as maximum plasma concentration, time to reach maximum concentration, area under the concentration-time curve, half-life, clearance, and volume of distribution. Safety will be monitored by tracking adverse events and immune responses. Participants' involvement will last from screening through Day 15 post-dose.
CONDITIONS
Brief Title
A Pharmacokinetic Study of YN001 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any assessments
- Healthy males and females aged 18 to 65 years at screening
- Good health determined by medical history, physical exam, vital signs, ECG, and labs at screening and baseline
- Vital signs within specified ranges: temperature 35.5-37.7 °C, systolic blood pressure 90-140 mm Hg, diastolic blood pressure 40-95 mm Hg, pulse rate 40-100 bpm
- 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...
- Receipt of investigational agent within 30 days or 5 half-lives prior to dosing
- Use of prescription drugs, OTC medications, herbal or dietary supplements, or vaccines within two weeks before dosing, unless approved
- Fasting triglycerides >2.8 mmol/L at screening or baseline
- History or presence of significant ECG abnormalities
- Pregnant or nursing women
- Smoking more than 5 cigarettes or equivalent nicotine products per week or unwilling to abstain during study
- History of drug or alcohol abuse within 12 months prior to dosing
- Positive hepatitis B, C, or HIV test at screening
- History or susceptibility to muscle disorders or allergic reactions to study drug
- Recent blood or plasma donation exceeding specified volumes
- Hemoglobin below 120 g/L at screening or baseline
- Recent or recurrent autonomic dysfunction, bronchospastic or cardiac diseases
- Significant food allergies (except mild lactose or glucose intolerance)
- Medical conditions affecting drug metabolism or study safety
- Significant illness resolved within 2 weeks prior to dosing
- Any condition or circumstance that may impede study compliance or completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 27 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (Day -1)
Participants complete baseline assessments before receiving the study drug.
1 visit (in-person)
Duration - 1 day (Day 1)
Participants receive a single intravenous dose of YN001 and undergo pharmacokinetic assessments.
1 visit (in-person)
Duration - 14 days (Day 2 to Day 15)
Participants are monitored for safety and pharmacokinetic outcomes including adverse events and antibody levels.
Multiple visits including assessments on Day 5, Day 8, and a completion phone call on Day 15
Trial Site Locations
Total: 1 location
1
CMAX Clinical Research
Adelaide, South Australia, Australia
Actively Recruiting
Research Team
K
Kerry Xu
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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