Placebo
DrugMatching placebo to UTTR1147A administered intravenously
NCT Number: NCT02749630
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 1
Charité Research Organisation GmbH, Berlin, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
General inclusion criteria:
For HVs Only:
For Participants with UC or CD:
Exclusion criteria
General exclusion criteria:
For HVs Only:
For Participants with UC or CD:
Matching placebo to UTTR1147A administered intravenously
Escalating doses of intravenously administered UTTR1147A
Other names: efmarodocokin alfa, RO7021610, RG7880, IL-22Fc
Time frame: Up to Day 134
Time frame: Up to Day 134
Time frame: Up to Day 134
Time frame: Up to Day 134
Time frame: Up to Day 134
Time frame: Up to Day 134
Time frame: Up to Day 134
Time frame: Up to Day 134
Genentech, Inc.
Industry
An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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