A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms

Conditions

• Hydroxocobalamin Adverse Reaction

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Accepted

Interventions

• Hydroxocobalamin — DRUG
  Hydroxocobalamin drug, or Vitamin B12a, generally used to treat cyanide toxicity.

Study Details

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 Dates

Start date

Jan 2, 2023

Status verified

Mar 2026

Primary completion

Jun 30, 2023

Completion

Jun 30, 2023

Study Design

Enrollment

10 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Experimental: Hydroxocobalamin

Primary Outcome Measure

Adverse Events of Hydroxocobalamin Drug [ Time Frame: 2 weeks ]

Locations (1)

Find similar trials in Boston, MA