Phase 1 Pharmacokinetics, Safety, and Tolerability Study

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: XG005; Drug: Placebos

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Linear Clinical Research Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event related to XG005	Adverse Event reported as mild, moderate, severe on physical exam, ECG and laboratory results	Day 1 to 7 days after last dose

Collaborators and Investigators

• Sponsor: Xgene Pharmaceutical Pty Ltd
• Investigators: Study Chair: Feng Xu, PHD, Xgene Pharmaceutical Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Actual): December 3, 2019
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: XG005-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No