Phase 1 Pharmacokinetics, Safety, and Tolerability Study
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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
Drug: XG005Drug: Placebos
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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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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