Clinical Trial

A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms

Study acronym: Shrimp
Completed Phase 1
View on ClinicalTrials.gov →
Summary
We are planning a series of studies in individuals with ulcerative colitis, primary sclerosing cholangitis and pouchitis to determine if hydroxocobalamin is an effective therapy to treat these conditions. For these indications we are submitting INDs to the FDA as well as protocols to the IRB. Hydroxocobalamin, referred to as vitamin B12a has been approved by the FDA for treatment of cyanide toxicity in up to 5 grams intravenously over 15 minutes twice in a brief period. This has been tested and used in intravenous doses as high as 15 grams in a day. We will be utilizing its pharmacokinetic and safety profile to treat several subsets of patients. We are testing this initially in a healthy population to assess tolerability.
Trial Details
NCT Number NCT07469189
Lead Sponsor Brigham and Women's Hospital
Conditions Hydroxocobalamin Adverse Reaction
Enrollment 10 participants
Start Date 2023-01-02
Primary Completion 2023-06-30 (estimated)
Study Completion 2023-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-13