Clinical trial NCT04283474: Phase 1 XG005-03 Topical Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Xgene Pharmaceutical Group
Sponsor class: INDUSTRY
First posted: 2020-02-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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 topical applications in healthy subjects. The trial consists of two parts: a single ascending dose (SAD; Part 1) and a multiple ascending dose (MAD; Part 2). The MAD study will begin after the SAD portion of the study is complete.

The study will consist of 4 weeks of screening period, treatment period (1 day of dosing for SAD and 6.5 days for MAD), and 14 days of safety follow-up period. Each subject will serve as his/her own control, as the XG005-03 and placebo will be applied on contralateral legs. Application of XG005-03 or placebo to a particular leg will be randomly assigned.

Approximately 36 healthy subjects will be enrolled. Eighteen healthy subjects (3 alternates per dose group) in Part 1 (SAD) and Part 2 (MAD), who fulfill eligibility criteria will receive the study drug: XG005-03 (1%, 5%, and 10%) and placebo.

Eligibility criteria: Inclusion Criteria:

1. Healthy males or females between 18 and 55 years of age
2. BMI 18.0 to 30.0 kg/m2
3. Non-pregnant, non-breastfeeding female subjects

Exclusion Criteria:

1. Unstable or severe illness
2. Skin infection or lesion
3. Subjects with scars, moles, tattoos at application site
4. Expose to excessive UV
5. Hypersensitivity or allergy to NSAID

Primary outcomes:
measure: Pharmacokinetic Analyses
timeFrame: Day 1 to 4 days after last dose
measure: Pharmacokinetic Analyses
timeFrame: Day 1 to 4 days after last dose
measure: Pharmacokinetic Analyses
timeFrame: Day 1 to 4 days after last dose
measure: Pharmacokinetic of XG005-03 in 1%, 5%, and 10% concentrations
timeFrame: Day 1 to 4 days after last dose
measure: Pharmacokinetic Analyses
timeFrame: Day 1 to 4 days after last dose
measure: Pharmacokinetic Analyses
timeFrame: Day 1 to 4 days after last dose
Secondary outcomes:
measure: Safety Analyses
timeFrame: treatment to follow up period, a average 20 days
measure: Safety Analyses
timeFrame: treatment to follow up period, a average 20 days
measure: Safety Analyses
timeFrame: treatment to follow up period, a average 20 days
measure: Safety Analyses
timeFrame: treatment to follow up period, a average 20 days
measure: Safety Analyses
timeFrame: treatment to follow up period, a average 20 days
measure: Safety Analyses
timeFrame: treatment to follow up period, a average 20 days
measure: Safety Analyses
timeFrame: treatment to follow up period, a average 20 days
measure: Safety Analyses
timeFrame: treatment to follow up period, a average 20 days
measure: Safety Analyses
timeFrame: treatment to follow up period, a average 20 days
measure: Safety Analyses
timeFrame: treatment to follow up period, a average 20 days
measure: Safety Analyses
timeFrame: treatment to follow up period, a average 20 days
measure: Safety Analyses
timeFrame: treatment to follow up period, a average 20 days
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research Pty Ltd
state: South Australia
Study officials:
affiliation: Xgene Pharmaceutical Group
name: Feng Xu, PHD
role: STUDY_CHAIR
References: