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YJ001 for Spray Use for Safety and Tolerability

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

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -28 to day 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -28 to day 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events and significant laboratory abnormality
Systemic exposure of the 4 analytes to be assayed

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical research project permit the participation of individuals under 25 years old?

"This medical research is enrolling volunteers aged 18 and under 55."

Answered by AI

Is enrollment still underway for this experiment?

"Yes, the details on clinicaltrials.gov demonstrate that this research is actively looking for enrollees. The experiment was initially advertised on August 15th 2022 and most recently updated on August 29th 2022. 32 individuals are invited to take part in this trial at a single location."

Answered by AI

What is the total amount of participants being recruited for this trial?

"Affirmative. According to the most recent updates on clinicaltrials.gov, this study is actively recruiting 32 patients from 1 medical centre. This trial was initially listed on August 15th of 2022 and its details were last revised two weeks later."

Answered by AI

Is it possible to participate in this medical experiment?

"This clinical study has vacancies for 32 adults between the ages of 18-55, demonstrating sufficient safety and tolerability. Eligible participants must also be male or female, weigh a minimum of 50 kg (males) / 45 kg (females), possess two feet with five digits each boasting at least 450 cm2 total surface area from ankle to toes; have an uneventful medical history in past 6 months, resting blood pressure 90-140 systolic/60-90 diastolic mmHg and heart rate 45 - 100 bpm; creatinine clearance within normal range according to CKD EPI Creatinine"

Answered by AI

Has the FDA sanctioned YJ001 for aerosolized application?

"Limited data on safety and efficacy for YJ001 has led our team to assign a score of 1. This is based off its status as a Phase 1 clinical trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Single-Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of YJ001 in Healthy Volunteers
2022. "Single-Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of YJ001 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05451667.
~12 spots leftby Apr 2025
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