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
Overview
- Phase
- Phase 1
- Intervention
- XG005
- Conditions
- Pain
- Sponsor
- Xgene Pharmaceutical Group
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Adverse Event related to XG005
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
XG005
XG005 in 4 dose levels
Intervention: XG005
Placebo
Placebo in all cohort
Intervention: Placebos
Outcomes
Primary Outcomes
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