Phase 1 XG005-03 Topical Study
A Phase 1, Single-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of XG005-03 (Topical) in Healthy Subjects
1 other identifier
interventional
36
1 country
1
Brief Summary
Phase 1, randomized, single-blinded, placebo-control, ascending single and multiple dose of the PK, safety, and tolerability of XG005-03 topical formulation in Healthy Volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 pain
Started Feb 2020
Typical duration for phase_1 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedStudy Start
First participant enrolled
February 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2021
CompletedMarch 25, 2021
March 1, 2021
11 months
February 12, 2020
March 23, 2021
Conditions
Outcome Measures
Primary Outcomes (6)
Pharmacokinetic Analyses
peak concentration (Cmax)
Day 1 to 4 days after last dose
Pharmacokinetic Analyses
time to peak concentration (Tmax)
Day 1 to 4 days after last dose
Pharmacokinetic Analyses
terminal elimination rate constant (Kel)
Day 1 to 4 days after last dose
Pharmacokinetic of XG005-03 in 1%, 5%, and 10% concentrations
half-life (t½)
Day 1 to 4 days after last dose
Pharmacokinetic Analyses
area under the concentration-time curve from time 0 to the last measurable concentration timepoint (AUC0-t)
Day 1 to 4 days after last dose
Pharmacokinetic Analyses
area under the concentration-time curve, extrapolated to infinity (AUC0-∞)
Day 1 to 4 days after last dose
Secondary Outcomes (12)
Safety Analyses
treatment to follow up period, a average 20 days
Safety Analyses
treatment to follow up period, a average 20 days
Safety Analyses
treatment to follow up period, a average 20 days
Safety Analyses
treatment to follow up period, a average 20 days
Safety Analyses
treatment to follow up period, a average 20 days
- +7 more secondary outcomes
Study Arms (2)
XG005-03
EXPERIMENTALXG005-03 in 3 dose levels
Placebo
PLACEBO COMPARATORPlacebo in all cohort
Interventions
Eligibility Criteria
You may qualify if:
- Healthy males or females between 18 and 55 years of age
- BMI 18.0 to 30.0 kg/m2
- Non-pregnant, non-breastfeeding female subjects
You may not qualify if:
- Unstable or severe illness
- Skin infection or lesion
- Subjects with scars, moles, tattoos at application site
- Expose to excessive UV
- Hypersensitivity or allergy to NSAID
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Feng Xu, PHD
Xgene Pharmaceutical Group
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2020
First Posted
February 25, 2020
Study Start
February 28, 2020
Primary Completion
January 28, 2021
Study Completion
January 28, 2021
Last Updated
March 25, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share