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NCT07469189 · ClinicalTrials.gov registry record · Phase 1
A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms
A Phase 1 study of Hydroxocobalamin Adverse Reaction, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT07469189: Completed Phase 1 study of Hydroxocobalamin Adverse Reaction, sponsored by Brigham and Women's Hospital.
NCT07469189 is a Phase 1 study of Hydroxocobalamin Adverse Reaction that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07469189, a Phase 1 study of Hydroxocobalamin Adverse Reaction, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Stool consistency, stool frequency, Bristol Stool Chart score, GI symptoms
Conditions Studied
Interventions
- DRUG Hydroxocobalamin
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-01-02 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 1 |
What the finished NCT07469189 record still lists
NCT07469189 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Hydroxocobalamin Adverse Reaction appearing as the primary indexed condition, and to 1 intervention - of which Hydroxocobalamin is the first listed.
NCT07469189 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07469189 about?
NCT07469189 is a clinical study titled "A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms". 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. Hydrox...
What is the current status of trial NCT07469189?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-01-02. Estimated completion is 2023-06-30.
What conditions does trial NCT07469189 study?
This clinical trial studies the following conditions: Hydroxocobalamin Adverse Reaction.
What interventions are being tested in trial NCT07469189?
The interventions under investigation include: Hydroxocobalamin (DRUG).
Who is sponsoring clinical trial NCT07469189?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07469189 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07469189's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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