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Single-Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of YJ001 in Healthy Volunteers

NCT05451667 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-01-04

No results posted yet for this study

Summary

This phase I, randomized, double-blind, placebo controlled study is to investigate the safety, tolerability and pharmacokinetics (PK) of topically administered YJ001 in a single-ascending dose (SAD) fashion in healthy volunteers between 18 to 55 years of age, to establish the dosage range for spray use, and to provide a dosage regimen for Phase I multiple-ascending dose (MAD) study in healthy subjects. The study is to enroll 4 cohorts, the doses of which are 148, 296, 552 and 828 mg, with the option to enroll 2 additional cohorts (8 subjects for each cohort) without requiring a protocol amendment. Subjects will be screened between Day -28 and Day -2 and will be admitted to the clinic on Day -1. Subjects will be housed within the clinic from Day -1 through Day 8 and will be discharged on Day 8 after all scheduled study procedures have been completed.

Conditions

  • Safety and Tolerability

Interventions

DRUG

YJ001 for Spray Use

YJ001 (active ingredient)

DRUG

Placebo of YJ001 for Spray Use

Hydroxypropyl Methylcellulose

Sponsors & Collaborators

  • Zhejiang Yuejia Pharmaceuticals Co., Ltd.

    collaborator INDUSTRY

  • Yuejia Pharmaceuticals (USA), Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2022-12-20
Completion
2022-12-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05451667 on ClinicalTrials.gov