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Single-Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of YJ001 in Healthy Volunteers
Phase 1
Waitlist Available
Research Sponsored by Yuejia Pharmaceuticals (USA), Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -28 to day 8
Awards & highlights
All Individual Drugs Already Approved
Summary
This trial tests a skin spray called YJ001 on healthy adults aged 18-55 to see how safe it is and how the body handles it. Researchers will check how much of the spray gets into the blood and how it leaves the body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day -28 to day 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -28 to day 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events and significant laboratory abnormality
Systemic exposure of the 4 analytes to be assayed
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4 (6 active, 2 placebo)Experimental Treatment2 Interventions
828 mg
Group II: Cohort 3 (6 active, 2 placebo)Experimental Treatment2 Interventions
552 mg
Group III: Cohort 2 (6 active, 2 placebo)Experimental Treatment2 Interventions
296 mg
Group IV: Cohort 1 (6 active, 2 placebo)Experimental Treatment2 Interventions
148 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
YJ001 for Spray Use
2022
Completed Phase 1
~40
Methylcellulose
FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Yuejia Pharmaceuticals (USA), Inc.Lead Sponsor
Zhejiang Yuejia Pharmaceuticals Co., Ltd.Industry Sponsor