Inflammatory Bowel DiseasePhase 1NCT00868660
Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose
A Phase 1 study testing ZP1848 in people with Inflammatory Bowel Disease, run by Zealand Pharma at 1 site in United States.
Trial summary
Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- ZP1848
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Feb 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy adult male and/or females, 18 to 50 years of age
- Body mass index (BMI)18-30. Chrons Inclusion
- Adult male and/or females, 18 to 60 years of age (inclusive).
- Body mass index (BMI) ≥ 18 and ≤ 30 (kg/m2).
- Crohn's Disease Activity Index (CDAI) score < 150.
- In a stable state of Crohn's disease as per the Investigator's opinion.
- Free of steroid treatment (therapy targeted for the GI tract only) within the 3 months prior to Day 1.
Who cannot join
- History or presence of dysplasia, cancer, chronic hepatitis, HIV, tuberculosis (TB), or histoplasmosis.
- Fistula within the 3 months prior to dosing. 3. Ostomy (having ostomy now or at any time in the past). 4. Any surgery for the treatment of inflammatory bowel disease (IBD) within the 3 months prior to Day 1. 5. Short Bowel Syndrome (SBS). 6. Any other condition, chronic disease, or prior therapy, which in the opinion of the Investigator/Investigator's designee would put the patient at undue risk or would make the patient unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Double Blind, Placebo-Controlled Study of ZP1848 Administered as Subcutaneous Bolus Injections in Healthy Subjects Followed by Multiple Doses in Patients With Crohn's Disease in Remission
Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose
Read the detailed description
A Phase I, Double blind, Placebo-controlled, safety and tolerability study of ZP1848 administered as Ascending single Dose, SUBCUTANEOUS bolus injections in healthy SUBJECTS followed by a Multiple Dose cohort of patients with stable Crohn's disease in remission
- Conditions
- Inflammatory Bowel Disease
- Being tested
- ZP1848
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZP1848Drug
sc. bolus
| Study group | Role | What they receive |
|---|---|---|
| ZP1848 | Experimental | Healthy Subjects or Crohn's Disease patients Receives: Drug: ZP1848 |
| Placebo | Placebo comparator | Healthy subjects or Crohn's Disease patients Receives: Drug: ZP1848 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability
Measured: January2009-January2010
Secondary outcomes (1)
Pharmacokinetics
Measured: Jan 2009 - Jan 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel 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
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christian Thorkildsen, Study director, Zealand Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868660
- Sponsor's protocol ID
- ZP08-216
- Other IDs
- AA75468
- Status last verified
- Nov 2010
- First submitted
- 23 Mar 2009
- Last updated
- 2 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double Blind, Placebo-Controlled Study of ZP1848 Administered as Subcutaneous Bolus Injections in Healthy Subjects Followed by Multiple Doses in Patients With Crohn's Disease in Remission
- ClinicalTrials.gov ID
- NCT00868660
- Acronym / sponsor ID
- ZP08-216
- Conditions
- Inflammatory Bowel Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 25 Mar 2009 (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.
Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose
Detailed description
A Phase I, Double blind, Placebo-controlled, safety and tolerability study of ZP1848 administered as Ascending single Dose, SUBCUTANEOUS bolus injections in healthy SUBJECTS followed by a Multiple Dose cohort of patients with stable Crohn's disease in remission
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZP1848 | Experimental | Drug: ZP1848Healthy Subjects or Crohn's Disease patients |
| Placebo | Placebo comparator | Drug: ZP1848Healthy subjects or Crohn's Disease patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adult male and/or females, 18 to 50 years of age
- Body mass index (BMI)18-30. Chrons Inclusion
- Adult male and/or females, 18 to 60 years of age (inclusive).
- Body mass index (BMI) ≥ 18 and ≤ 30 (kg/m2).
- Crohn's Disease Activity Index (CDAI) score < 150.
Key exclusion criteria (2 listed)
- History or presence of dysplasia, cancer, chronic hepatitis, HIV, tuberculosis (TB), or histoplasmosis.
- Fistula within the 3 months prior to dosing. 3. Ostomy (having ostomy now or at any time in the past). 4. Any surgery for the treatment of inflammatory bowel disease (IBD) within the 3 months prior to Day 1. 5. Short Bowel Syndrome (SBS). 6. Any other condition, chronic disease, or prior therapy, which in the opinion of the Investigator/Investigator's designee would put the patient at undue risk or would make the patient unsuitable for the study.
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 |
|---|---|---|
| ZP1848sc. bolus | Drug | Placebo, ZP1848 |
Primary outcome
safety and tolerability
Time frame: January2009-January2010
1 secondary outcome
Pharmacokinetics
Time frame: Jan 2009 - Jan 2010
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 2 Nov 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.
Christian Thorkildsen study director
Zealand Pharma A/S
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 ZP1848 in people with Inflammatory Bowel Disease, run by Zealand Pharma 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 7 inclusion and 2 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 2 Nov 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. 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: January2009-January2010). 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 2 Nov 2010.