Diabetes Mellitus, Insulin-DependentPhase 1NCT00073255
Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM)
A Phase 1 study testing hokt3g1 (ALA-ALA) in people with Diabetes Mellitus, Insulin-Dependent, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
To assess the tolerability and safety of hOKT3g1 (Ala-Ala) after a 12-day dosing regimen administered via intravenous infusion. To assess the pharmacokinetics of hOKT3g1 (Ala-Ala). Read more about this study
- Who is it for?
- Ages 8 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Insulin-Dependent
- What is being tested?
- hokt3g1 (ALA-ALA)
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Dec 2005
- 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 8 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
To be eligible
- participants will have Type 1 diabetes, diagnosed within the previous 12 months and established by standard American Diabetes Association criteria.
- All participants will have autoantibodies: either anti-GAD65, anti-ICA512, or if treated with insulin for less than 7 days, anti-insulin.
- The age range will be between 8 and 30 years; and
- a minimum weight of 34 kg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Tolerability, Safety, and Pharmacokinetics of hOKT3g1 (Ala-Ala)
To assess the tolerability and safety of hOKT3g1 (Ala-Ala) after a 12-day dosing regimen administered via intravenous infusion. To assess the pharmacokinetics of hOKT3g1 (Ala-Ala).
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Being tested
- hokt3g1 (ALA-ALA)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hokt3g1 (ALA-ALA)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2003 (estimated)
- Study startJun 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Insulin-DependentStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073255
- Sponsor's protocol ID
- ITNO17AI (completed)
- Status last verified
- Jan 2010
- First submitted
- 18 Nov 2003
- Last updated
- 15 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tolerability, Safety, and Pharmacokinetics of hOKT3g1 (Ala-Ala)
- ClinicalTrials.gov ID
- NCT00073255
- Acronym / sponsor ID
- ITNO17AI (completed)
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jun 2003
- Study completion
- Dec 2005
- First posted
- 20 Nov 2003 (estimated)
- 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.
To assess the tolerability and safety of hOKT3g1 (Ala-Ala) after a 12-day dosing regimen administered via intravenous infusion. To assess the pharmacokinetics of hOKT3g1 (Ala-Ala).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| hokt3g1 (ALA-ALA) | Drug | – |
Primary outcome
Not reported in the source record.
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 15 Jan 2010.
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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 hokt3g1 (ALA-ALA) in people with Diabetes Mellitus, Insulin-Dependent, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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?
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 15 Jan 2010. 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.
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 15 Jan 2010.