Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 6:20 PM
Study NCT ID:
NCT05451667
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2022-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of YJ001 in Healthy Volunteers
Sponsor:
Yuejia Pharmaceuticals (USA), Inc.
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Double-Blind, Placebo Controlled Single-Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Topical Application of YJ001 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
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. Each cohort will consist of 8 subjects (6 active; 2 placebo). Each subject will be administered a single dose of YJ001 as multiple sprays (8 sprays/foot for Cohort 1, 16 sprays/foot for Cohort 2, 16 sprays/foot for Cohort 3, and 24 sprays/foot for Cohort 4) topically on both feet; and below the ankle, with the administration area set as 450 cm2 (both feet).
Safety will be evaluated by assessing incidence and severity of adverse events (AEs) and serious adverse events (SAEs); observed values and changes in baseline of clinical safety laboratory test results, 12-lead electrocardiogram (ECG), vital signs; and physical examination inclusive of skin reaction findings at the Investigational Product (IP) administration sites.
For pharmacokinetics evaluation, serial blood samples will be collected in the subjects of Cohorts 2 to 4 for up to 7 days following a single dose to assess the PK of YJ001 and metabolites in plasma. Pooled urine samples will be collected in the subjects of Cohorts 2 to 4 to evaluate renal excretion of YJ001 and metabolites.
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.
Safety will be evaluated by assessing incidence and severity of adverse events (AEs) and serious adverse events (SAEs); observed values and changes in baseline of clinical safety laboratory test results, 12-lead electrocardiogram (ECG), vital signs; and physical examination inclusive of skin reaction findings at the Investigational Product (IP) administration sites.
For pharmacokinetics evaluation, serial blood samples will be collected in the subjects of Cohorts 2 to 4 for up to 7 days following a single dose to assess the PK of YJ001 and metabolites in plasma. Pooled urine samples will be collected in the subjects of Cohorts 2 to 4 to evaluate renal excretion of YJ001 and metabolites.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: