Hydroxocobalamin Adverse ReactionPhase 1ShrimpNCT07469189
A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms
A Phase 1 study testing Hydroxocobalamin in people with Hydroxocobalamin Adverse Reaction, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydroxocobalamin Adverse Reaction
- What is being tested?
- Hydroxocobalamin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2023to 30 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-70
- Ability to give consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the detailed description
Patients will be recruited at Brigham and Women's Hospital (BWH), at both the main campus and 850 Boylston Street locations. Healthy subjects may be identified as family members of patients who are picking them up from colonoscopy procedures or through the Mass General Brigham Rally system. Flyers and emails will inform interested subjects of the trial and will assist with recruitment.
Patients may be identified by their physician or by a research coordinator with physician permission. Patients identified by their healthcare providers who may meet entry criteria would be approached by a study team member to explain about the trial in more detail and to offer participation. In collaboration with their physician, the patient will decide whether to consent and participate.
We aim to enroll up to 10 individuals for the study. Individuals will be requested to maintain their diets in their usual intake and avoid those foods which they are aware that may induce diarrhea or looser stools for them.
Patients will be given different oral doses of hydroxocobalamin to assess tolerability.
- Conditions
- Hydroxocobalamin Adverse Reaction
- Being tested
- Hydroxocobalamin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroxocobalaminDrug
Hydroxocobalamin drug, or Vitamin B12a, generally used to treat cyanide toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxocobalamin | Experimental | Not described Receives: Drug: Hydroxocobalamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events of Hydroxocobalamin Drug
Stool consistency, stool frequency, Bristol Stool Chart score, GI symptoms
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start2 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydroxocobalamin Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Korzenik, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469189
- Sponsor's protocol ID
- 2022P003028
- Acronym
- Shrimp
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms
- ClinicalTrials.gov ID
- NCT07469189
- Acronym / sponsor ID
- Shrimp / 2022P003028
- Conditions
- Hydroxocobalamin Adverse Reaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will be recruited at Brigham and Women's Hospital (BWH), at both the main campus and 850 Boylston Street locations. Healthy subjects may be identified as family members of patients who are picking them up from colonoscopy procedures or through the Mass General Brigham Rally system. Flyers and emails will inform interested subjects of the trial and will assist with recruitment.
Patients may be identified by their physician or by a research coordinator with physician permission. Patients identified by their healthcare providers who may meet entry criteria would be approached by a study team member to explain about the trial in more detail and to offer participation. In collaboration with their physician, the patient will decide whether to consent and participate.
We aim to enroll up to 10 individuals for the study. Individuals will be requested to maintain their diets in their usual intake and avoid those foods which they are aware that may induce diarrhea or looser stools for them.
Patients will be given different oral doses of hydroxocobalamin to assess tolerability.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydroxocobalamin | Experimental | Drug: Hydroxocobalamin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18-70
- Ability to give consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxocobalaminHydroxocobalamin drug, or Vitamin B12a, generally used to treat cyanide toxicity. | Drug | Hydroxocobalamin |
Primary outcome
Adverse Events of Hydroxocobalamin Drug
Time frame: 2 weeks
Stool consistency, stool frequency, Bristol Stool Chart score, GI symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydroxocobalamin in people with Hydroxocobalamin Adverse Reaction, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events of Hydroxocobalamin Drug (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.