Healthy VolunteersPhase 1NCT01203124
A Study to Investigate the Impact of Dose and Dosing Frequency of AZD8848 on the Response on Biomarkers
A Phase 1 study testing AZD8848 in people with Healthy Volunteers, run by AstraZeneca at 1 site in Sweden.
Trial summary
The study will investigate how the dose of AZD8848 and the dosing frequency will affect the immunological/inflammatory response by measuring the production of biomarkers in blood and nasal lavage. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AZD8848
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2010to Feb 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men or women aged 18 to 55 years (inclusive). Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue on the chosen contraceptive method, with additional use of a condom by male partners, until 3 months after last dose.
- Female subjects should have a negative pregnancy test at Visit 2 and date of last menstruation consistent of non-pregnancy
- Ability to metabolise AZD8848 (an in vitro screening assay will determine metabolic activity in a blood sample taken at Visit 1 using a pre-defined limit)
Who cannot join
- Any clinically significant disease or disorder
- Any clinically relevant abnormal findings in physical examination
- Structural abnormalities of the nose or nasal disorder symptomatic enough to cause significant nasal obstruction
- Ongoing pregnancy or lactation
- Abnormal immune function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blind, Randomized, Placebo Controlled, Parallel-group, Adaptive-design Study to Investigate the Impact of Dose and Dosing Frequency of AZD8848 Administered Intranasally for up to 7 Days, on the Biomarker
The study will investigate how the dose of AZD8848 and the dosing frequency will affect the immunological/inflammatory response by measuring the production of biomarkers in blood and nasal lavage.
- Conditions
- Healthy Volunteers
- Being tested
- AZD8848, Placebo
- Keywords
- Intranasal, Biomarker, Healthy, Effect of different doses and dosing regimens of AZD8848 on biomarkers, Effect different doses and dosing frequency of AZD8848 on biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8848Drug
The subjects are dosed with a range of intranasal doses of AZD8848 on 2, 3, 4 or 7 days of the 7 days treatment period. On the other days the subjects receive placebo.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo given once daily on 7 days Receives: Drug: Placebo |
| 2 | Experimental | Active treatment at Day 1 and Day 7. Placebo on Day 2, 3, 4, 5 and 6 Receives: Drug: AZD8848; Drug: Placebo |
| 3 | Experimental | Active treatment at Day 1, 4 and 7. Placebo on Day 2, 3, 5 and 6. Receives: Drug: AZD8848; Drug: Placebo |
| 4 | Experimental | Active treatment at Day 1, 3, 5 and 7. Placebo on Day 2, 4 and 6. Receives: Drug: AZD8848; Drug: Placebo |
| 5 | Experimental | Active treatment once daily on 7 days Receives: Drug: AZD8848 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
Measured: Samples collected pre-dose and 1 day after first dose.
CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
Measured: Samples collected pre-dose and 7 days after first dose.
CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
Measured: Samples collected pre-dose and 8 days after first dose.
CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
Measured: Samples collected pre-dose and 10 days after first dose.
CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
Measured: Samples collected pre-dose and 12-14 days after first dose.
Secondary outcomes (1)
To assess safety and tolerability of intranasal administration of AZD8848 at different doses and dosing regimens
Measured: During the 7 days dosing period and at four follow-up visits up to 11-13 months after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leif T Eriksson, MD, PhD, Study director, AstraZenecaWolfgang Kuhn, MD, Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203124
- Sponsor's protocol ID
- D0540C00016
- Other IDs
- 2010-022574-14
- Status last verified
- Aug 2015
- First submitted
- 15 Sep 2010
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomized, Placebo Controlled, Parallel-group, Adaptive-design Study to Investigate the Impact of Dose and Dosing Frequency of AZD8848 Administered Intranasally for up to 7 Days, on the Biomarker
- ClinicalTrials.gov ID
- NCT01203124
- Acronym / sponsor ID
- D0540C00016
- Conditions
- Healthy Volunteers
- Keywords
- Intranasal, Biomarker, Healthy, Effect of different doses and dosing regimens of AZD8848 on biomarkers, Effect different doses and dosing frequency of AZD8848 on biomarkers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 16 Sep 2010 (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.
The study will investigate how the dose of AZD8848 and the dosing frequency will affect the immunological/inflammatory response by measuring the production of biomarkers in blood and nasal lavage.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo given once daily on 7 days |
| 2 | Experimental | Drug: AZD8848, Drug: PlaceboActive treatment at Day 1 and Day 7. Placebo on Day 2, 3, 4, 5 and 6 |
| 3 | Experimental | Drug: AZD8848, Drug: PlaceboActive treatment at Day 1, 4 and 7. Placebo on Day 2, 3, 5 and 6. |
| 4 | Experimental | Drug: AZD8848, Drug: PlaceboActive treatment at Day 1, 3, 5 and 7. Placebo on Day 2, 4 and 6. |
| 5 | Experimental | Drug: AZD8848Active treatment once daily on 7 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men or women aged 18 to 55 years (inclusive). Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue on the chosen contraceptive method, with additional use of a condom by male partners, until 3 months after last dose.
- Female subjects should have a negative pregnancy test at Visit 2 and date of last menstruation consistent of non-pregnancy
- Ability to metabolise AZD8848 (an in vitro screening assay will determine metabolic activity in a blood sample taken at Visit 1 using a pre-defined limit)
Key exclusion criteria (5 listed)
- Any clinically significant disease or disorder
- Any clinically relevant abnormal findings in physical examination
- Structural abnormalities of the nose or nasal disorder symptomatic enough to cause significant nasal obstruction
- Ongoing pregnancy or lactation
- Abnormal immune function
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 |
|---|---|---|
| AZD8848The subjects are dosed with a range of intranasal doses of AZD8848 on 2, 3, 4 or 7 days of the 7 days treatment period. On the other days the subjects receive placebo. | Drug | 2, 3, 4, 5 |
| PlaceboPlacebo | Drug | 1, 2, 3, 4 |
Primary outcome
CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
Time frame: Samples collected pre-dose and 1 day after first dose.
CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
Time frame: Samples collected pre-dose and 7 days after first dose.
CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
Time frame: Samples collected pre-dose and 8 days after first dose.
CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
Time frame: Samples collected pre-dose and 10 days after first dose.
CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
Time frame: Samples collected pre-dose and 12-14 days after first dose.
1 secondary outcome
To assess safety and tolerability of intranasal administration of AZD8848 at different doses and dosing regimens
Time frame: During the 7 days dosing period and at four follow-up visits up to 11-13 months after the last dose
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 14 Aug 2015.
- CSR SynopsisLink provided by the sponsor.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Leif T Eriksson, MD, PhD study director
AstraZeneca
Wolfgang Kuhn, MD principal investigator
Quintiles, 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 AZD8848 in people with Healthy Volunteers, run by AstraZeneca at 1 site in Sweden.
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 3 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 14 Aug 2015. 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 Sweden. 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?
CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage (time frame: Samples collected pre-dose and 1 day after first dose.). The study lists 5 primary outcomes in all. 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 14 Aug 2015.