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Phase 1 Pharmacokinetics, Safety, and Tolerability 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067947
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Xgene Pharmaceutical Pty Ltd

Brief Summary:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers.

Condition or disease Intervention/treatment Phase
Pain Drug: XG005 Drug: Placebos Phase 1

Detailed Description:
This is a randomized, double-blind, placebo-controlled study which will investigate the PK, safety, and tolerability of four ascending single and multiple oral doses of XG005 in healthy subjects. The trial consists of two parts: a single ascending dose (SAD) PK evaluation (Part 1) and a multiple ascending dose (MAD) PK evaluation (Part 2). Approximately 32 Subjects will be enrolled sequentially into a total of 4 ascending dose levels in each part.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The Investigator or designee, study coordinator(s), subjects, the Sponsor study team and its representatives, will be blinded to the treatment assignment.
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers
Actual Study Start Date : July 8, 2019
Actual Primary Completion Date : December 3, 2019
Actual Study Completion Date : February 10, 2020

Arm Intervention/treatment
Experimental: XG005
XG005 in 4 dose levels
Drug: XG005
XG005 Tablet

Placebo Comparator: Placebo
Placebo in all cohort
Drug: Placebos
Placebo Tablet




Primary Outcome Measures :
  1. Adverse Event related to XG005 [ Time Frame: Day 1 to 7 days after last dose ]
    Adverse Event reported as mild, moderate, severe on physical exam, ECG and laboratory results



Information from the National Library of Medicine

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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. History of, or current treatment for, GI disease
  3. Clinically significant history of medical condition associated with GI events
  4. History of or current glucose intolerance or gestational diabetes
  5. Lifetime history of suicidal behavior
  6. Creatinine clearance < 90 mL/min
  7. Any elevation of liver function tests
  8. Creatine kinase (CK) value of greater than 1.5 times the upper limit
  9. Leucocytes or lymphocytes less than 1.5 times the lower limit of normal
  10. Positive Hepatitis B surface antigen, HCV, or HIV

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): NCT04067947


Locations
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Australia, Western Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009
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: NCT04067947    
Other Study ID Numbers: XG005-02
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: August 2019
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