Status:
COMPLETED
Phase 1 XG005-03 Topical Study
Lead Sponsor:
Xgene Pharmaceutical Group
Conditions:
Pain
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Detailed Description
This is a single-blind, placebo-controlled study which will investigate the PK, safety and tolerability of XG005-03 topical formulation, in three ascending concentrations after single and multiple top...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04283474
Start Date
February 28 2020
End Date
January 28 2021
Last Update
March 25 2021
Active Locations (1)
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1
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia, 5000