Celiac DiseasePhase 1NCT00626184
A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
A Phase 1 study testing 4 dose levels of ALV003 in people with Celiac Disease, run by Alvine Pharmaceuticals Inc. at 1 site in United States.
Trial summary
To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- 4 dose levels of ALV003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jul 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Health Status
- Healthy volunteers must be in good health
- Celiac Disease must be well controlled and in good health
- Either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods.
- Body Mass Index (BMI) of < 30 kg/m2,
Who cannot join
- A positive urine test for alcohol or illegal drugs at screening.
- The subject has received an experimental drug within 30 days of the present study.
- History of substance abuse, within the last 5 years
- Clinically significant abnormal lab values, as determined by the PI
- Alcohol consumption of > 2 standard drinks equivalents per day12. Positive pregnancy test within 7 days prior to study drug administration.
- history of any medically significant condition considered by the PI to adversely affect participation in the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Applications Laboratories Inc.
San Diego, California, 92103
About this study
Official title: A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease
Read the detailed description
A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
- Conditions
- Celiac Disease
- Being tested
- 4 dose levels of ALV003
- Keywords
- Celiac Disease
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 dose levels of ALV003Drug
Also called ALV003 and ALV003 placebo equivalent
4 dose levels of ALV003 vs placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo Receives: Drug: 4 dose levels of ALV003 |
| B | Active comparator | Active study Drug: ALV003 Receives: Drug: 4 dose levels of ALV003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability
Measured: Throughout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvine Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Vijaya Pratha, MD, Principal investigator, Clinical Applications Laboratory Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626184
- Sponsor's protocol ID
- ALV003-0811
- Status last verified
- Aug 2009
- First submitted
- 13 Feb 2008
- Last updated
- 18 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
- ClinicalTrials.gov ID
- NCT00626184
- Acronym / sponsor ID
- ALV003-0811
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Alvine Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 Feb 2008 (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 safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease
Detailed description
A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: 4 dose levels of ALV003Placebo |
| B | Active comparator | Drug: 4 dose levels of ALV003Active study Drug: ALV003 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Health Status
- Either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods.
- Body Mass Index (BMI) of < 30 kg/m2,
Key exclusion criteria (6 listed)
- A positive urine test for alcohol or illegal drugs at screening.
- The subject has received an experimental drug within 30 days of the present study.
- History of substance abuse, within the last 5 years
- Clinically significant abnormal lab values, as determined by the PI
- Alcohol consumption of > 2 standard drinks equivalents per day12. Positive pregnancy test within 7 days prior to study drug administration.
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 |
|---|---|---|
| 4 dose levels of ALV003Also: ALV003 and ALV003 placebo equivalent4 dose levels of ALV003 vs placebo | Drug | A, B |
Primary outcome
safety and tolerability
Time frame: Throughout
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 18 Aug 2009.
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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.
Vijaya Pratha, MD principal investigator
Clinical Applications Laboratory Inc.
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 4 dose levels of ALV003 in people with Celiac Disease, run by Alvine Pharmaceuticals Inc. 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 5 inclusion and 6 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 18 Aug 2009. 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. Some participants in this study may receive a placebo. 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?
safety and tolerability (time frame: Throughout). 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 18 Aug 2009.