A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms

Completed · Phase 1

Conditions studied: Hydroxocobalamin Adverse Reaction

In brief

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.

Key facts

Study ID

NCT07469189

Run by

Brigham and Women's Hospital

People needed

10

Starts

2023-01-02

Expected to finish

2023-06-30

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ages 18-70
• Ability to give consent

You may not qualify if…

• Patients who are pregnant or breastfeeding
• Use of chronic medications
• History of hypersensitivity to hydroxocobalamin
• History of chronic constipation or diarrhea
• History of IBS or other GI illness which causes symptoms of diarrhea or constipation

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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