Trial Details

Recruiting
Basic Information
Clinical ID c5474
Identifier ACTRN12618001210268
Trial Title A Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers
Trial URL Visit Original Page
Study Information
Study Results

NULL
Conditions Inflammatory Bowel Disease;Ulcerative colitis;Crohn's Disease; Inflammatory Bowel Disease Ulcerative colitis Crohn's Disease;Inflammatory and Immune System - Autoimmune diseases;Oral and Gastrointestinal - Crohn's disease
Interventions For single ascending dose, five dose target ranges of BT-11 (depending on body weight the doses in each cohort will be 5.9 7.7 mg/kg; 18.9 25.0 mg/kg; 44.3 50.0 mg/kg; 68.5 75 mg/kg and 94.2 100.0 mg/kg) will be evaluated, based on subject weight on Day
Participant Information
Sponsor Landos Biopharma Australia Pty Ltd
City NULL
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, OLDER_ADULT
Study Design
Study Type Interventional
Phase PHASE1
Time Information
Start Date NULL
Primary Completion Date NULL
Completion Date NULL