This is a randomized, observer-blinded, placebo-controlled study to evaluate safety, tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV) UTTR1147A. The study will consist of a repeat dose escalation in HVs, in participants with UC, and in participants with CD across multiple sites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
Charité Research Organisation GmbH
Berlin, Germany
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Percentage of Participants with Adverse Events
Time frame: Up to Day 134
Maximum Serum Concentration (Cmax) of UTTR1147A After the First and Last Dose
Time frame: Up to Day 134
Minimum (Trough) Serum Concentrations (Ctrough) of UTTR1147A Prior to the Second and Last Dose
Time frame: Up to Day 134
Total Serum Clearance (CL) of UTTR1147A
Time frame: Up to Day 134
Volume of Distribution (V) of UTTR1147A
Time frame: Up to Day 134
Area Under the Concentration vs. Time Curve (AUC) Within a Dose Interval (AUCtau) After the Final Dose of UTTR1147A
Time frame: Up to Day 134
Elimination Half-Life (t1/2) of UTTR1147A
Time frame: Up to Day 134
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) in Serum
Time frame: Up to Day 134
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