YJ001 for Spray Use for Safety and Tolerability

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pharmaron CPC, Inc., Baltimore, MD
Safety and Tolerability
YJ001 for Spray Use - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This trial is studying the safety of a new drug, YJ001, when applied to the skin. It will enroll 4 cohorts of 8-10 healthy volunteers between 18 and 55 years old. The YJ001 for Spray Use is used to treat Safety and Tolerability and has been approved by the FDA for a different condition. This treatment is free.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Safety and Tolerability

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Day -28 to Day 8

Day 8
Incidence of adverse events and significant laboratory abnormality
Day 8
Systemic exposure of the 4 analytes to be assayed

Trial Safety

Safety Progress

1 of 3

Other trials for Safety and Tolerability

Trial Design

4 Treatment Groups

Cohort 1 (6 active, 2 placebo)
1 of 4
Cohort 4 (6 active, 2 placebo)
1 of 4
Cohort 2 (6 active, 2 placebo)
1 of 4
Cohort 3 (6 active, 2 placebo)
1 of 4
Experimental Treatment

32 Total Participants · 4 Treatment Groups

Primary Treatment: YJ001 for Spray Use · Has Placebo Group · Phase 1

Cohort 1 (6 active, 2 placebo)Experimental Group · 2 Interventions: YJ001 for Spray Use, Placebo of YJ001 for Spray Use · Intervention Types: Drug, Drug
Cohort 4 (6 active, 2 placebo)Experimental Group · 2 Interventions: YJ001 for Spray Use, Placebo of YJ001 for Spray Use · Intervention Types: Drug, Drug
Cohort 2 (6 active, 2 placebo)Experimental Group · 2 Interventions: YJ001 for Spray Use, Placebo of YJ001 for Spray Use · Intervention Types: Drug, Drug
Cohort 3 (6 active, 2 placebo)Experimental Group · 2 Interventions: YJ001 for Spray Use, Placebo of YJ001 for Spray Use · Intervention Types: Drug, Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day -28 to day 8
Closest Location: Pharmaron CPC, Inc. · Baltimore, MD
Photo of Baltimore 1Photo of Baltimore 2Photo of Baltimore 3
2018First Recorded Clinical Trial
1 TrialsResearching Safety and Tolerability
7 CompletedClinical Trials

Who is running the clinical trial?

Zhejiang Yuejia Pharmaceuticals Co., Ltd.Industry Sponsor
Yuejia Pharmaceuticals (USA), Inc.Lead Sponsor

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between the ages of 18-55 years, both inclusive.
Subjects must understand verbal and/or written English or any other language in which a certified translation of the informed consent is available.
Subjects must have a body mass index (BMI) between 19.0 and 32.0 kg/m2 (both inclusive) at screening, calculated as weight (kg)/height2 (m2)
You have no history of any significant pathology/surgery in the last 6 months.
Subjects with either C-reactive protein of up to 3.
The device is inserted into the uterus.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.