A Phase 1 Study of Usynova Pharmaceuticals UA021 in healthy participants for the evaluation of safety, tolerability, and drug concentration in progressively increasing single and multiple daily dose levels
- Conditions
- PsoriasisInflammatory and Immune System - Autoimmune diseases
- Registration Number
- ACTRN12622001349730
- Lead Sponsor
- George Clinical Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 40
•Must be capable of giving a signed informed consent
•Participants in good health based on medical history, physical examinations, vital
signs, 12-lead ECGs, clinical laboratory tests as determined by the Investigator.
•Body mass index (BMI) within the range of 18~32 kg/m2 (inclusive) with a minimum
body weight of 45 kg at the screening visit.
•Adhere to effective double barrier contraception or are proven post-menopausal
•A history of stomach or intestinal surgery or resection that would potentially alter
the absorption and/or excretion of orally administered drugs taken.
•Presence of a malabsorption syndrome e.g., Crohn’s Disease
•Any clinically significant abnormalities in laboratory test results deemed clinically
significant by the Investigator.
•History of immunological disorders, auto-immune disorders, acquired or congenital
immune deficiency or acute infection within 3 months before the start of the screening
visit.
•Active or prior hepatitis B infection or positive test for HIV or Hepatitis C
•Poorly controlled hypertension or diabetes mellitus
•Major surgery within 6 months of study entry.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method