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NCT Number: NCT04067947

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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

Treatment and study plan

XG005

Drug

XG005 Tablet

Placebos

Drug

Placebo Tablet

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Xgene Pharmaceutical Group

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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