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Phase 1 XG005-03 Topical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283474
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Xgene Pharmaceutical Pty Ltd

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.

Condition or disease Intervention/treatment Phase
Pain Drug: XG005-03 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
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
Actual Study Start Date : February 28, 2020
Estimated Primary Completion Date : August 25, 2020
Estimated Study Completion Date : November 24, 2020

Arm Intervention/treatment
Experimental: XG005-03
XG005-03 in 3 dose levels
Drug: XG005-03
3 different concentrations (1%, 5%, 10%) of XG005-03 topical formulation

Placebo Comparator: Placebo
Placebo in all cohort
Drug: Placebo
Placebo topical formulation




Primary Outcome Measures :
  1. Pharmacokinetic Analyses [ Time Frame: Day 1 to 4 days after last dose ]
    peak concentration (Cmax)

  2. Pharmacokinetic Analyses [ Time Frame: Day 1 to 4 days after last dose ]
    time to peak concentration (Tmax)

  3. Pharmacokinetic Analyses [ Time Frame: Day 1 to 4 days after last dose ]
    terminal elimination rate constant (Kel)

  4. Pharmacokinetic of XG005-03 in 1%, 5%, and 10% concentrations [ Time Frame: Day 1 to 4 days after last dose ]
    half-life (t½)

  5. Pharmacokinetic Analyses [ Time Frame: Day 1 to 4 days after last dose ]
    area under the concentration-time curve from time 0 to the last measurable concentration timepoint (AUC0-t)

  6. Pharmacokinetic Analyses [ Time Frame: Day 1 to 4 days after last dose ]
    area under the concentration-time curve, extrapolated to infinity (AUC0-∞)


Secondary Outcome Measures :
  1. Safety Analyses [ Time Frame: treatment to follow up period, a average 20 days ]
    Adverse Event

  2. Safety Analyses [ Time Frame: treatment to follow up period, a average 20 days ]
    ECG-heart rate

  3. Safety Analyses [ Time Frame: treatment to follow up period, a average 20 days ]
    ECG-PR

  4. Safety Analyses [ Time Frame: treatment to follow up period, a average 20 days ]
    ECG-QRS

  5. Safety Analyses [ Time Frame: treatment to follow up period, a average 20 days ]
    ECG-QT

  6. Safety Analyses [ Time Frame: treatment to follow up period, a average 20 days ]
    ECG-QTc

  7. Safety Analyses [ Time Frame: treatment to follow up period, a average 20 days ]
    Skin Assessment Grading-Burger and Bowman scale

  8. Safety Analyses [ Time Frame: treatment to follow up period, a average 20 days ]
    Vital Sign-Systolic Blood Pressure

  9. Safety Analyses [ Time Frame: treatment to follow up period, a average 20 days ]
    Vital Sign-Diastolic Blood Pressure

  10. Safety Analyses [ Time Frame: treatment to follow up period, a average 20 days ]
    Vital Sign-Pulse Rate

  11. Safety Analyses [ Time Frame: treatment to follow up period, a average 20 days ]
    Vital Sign-Tympanic Temperature

  12. Safety Analyses [ Time Frame: treatment to follow up period, a average 20 days ]
    Vital Sign-Respiratory Rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283474


Contacts
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Contact: Katherine Mudge +61 431 739 345 Katherine.Mudge@cmax.com.au
Contact: Rhys Hamson +61 423 605 724 Rhys.Hamson@cmax.com.au

Locations
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Australia, South Australia
CMAX Clinical Research Pty Ltd Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Katherine Mudge    +61 431 739 345    Katherine.Mudge@cmax.com.au   
Contact: Rhys Hamson    +61 423 605 724    Rhys.Hamson@cmax.com.au   
Principal Investigator: Guy Ludbrook, Professor         
Sponsors and Collaborators
Xgene Pharmaceutical Pty Ltd
Investigators
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Study Chair: Feng Xu, PHD Xgene Pharmaceutical Pty Ltd
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Responsible Party: Xgene Pharmaceutical Pty Ltd
ClinicalTrials.gov Identifier: NCT04283474    
Other Study ID Numbers: PR-XG005-03-PK-01
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No