HealthyPhase 1NCT01560234

AZD8848 Single Ascending Dose Study

A Phase 1 study testing AZD8848 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of AZD8848 in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: AZD8848
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: 1 siteUnited Kingdom
Study dates: May 2012to Jul 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy men or women aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
Women can be of childbearing potential and must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 (screening) and be willing to continue on the chosen contraceptive method
Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the day of the investigational product administration until 3 months
Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Ability to produce sputum of good enough quality for assessment of biomarkers

Who cannot join

Abnormal vital signs, after 10 minutes supine rest, defined as any of the following (SBP > 140 mmHg, Diastolic blood pressure (DBP) > 90 mmHg, Heart rate < 40 or > 85 beats per minute)
Prolonged QTcF > 450 ms or shortened QTcF < 340 ms or family history of long QT syndrome
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class as AZD8848
History of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT syndrome, or sudden death)
History of asthma or allergic rhinitis

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Research Site
London

Other trials in United Kingdom

About this study

Official title: A Double-blind, Placebo-controlled, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD8848 in Healthy Subjects

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of AZD8848 in healthy subjects.

Read the detailed description

A Double-blind, Placebo-controlled, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD8848 in Healthy Subjects

Conditions: Healthy
Being tested: AZD8848, Placebo
Keywords: Safety, tolerability, healthy, pharmacokinetic, pharmacodynamic, inhaled
Medical subject headings: Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD8848Drug
Single dose, oral inhalation (nebuliser solution)
PlaceboDrug
Single dose, oral inhalation (nebuliser solution)

Study groups in NCT01560234
Study group	Role	What they receive
AZD8848	Experimental	Not described Receives: Drug: AZD8848
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events
Summary of number of subjects who had at least one adverse event
Measured: Screening up to Day 13
Summary for Lymphocytes Laboratory Results
Measured: Baseline, Day 1, Day 2, Day 3, and Follow up (up to Day 13)

Secondary outcomes (6)

Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC (Nmol*h/L)
Measured: On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h
Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC(0-t) (Nmol*h/L)
Measured: On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h
Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - Cmax (Nmol/L)
Measured: On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h
Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma
Smmarizes the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix
Measured: Baseline, 24 Hours.
Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma
Smmarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix
Measured: Baseline, 48 Hours
Statistical Assessment of CXCL10 Ratio-to-baseline- Sputum
Summarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix
Measured: Baseline, 24 Hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Jul 2014

First posted22 Mar 2012 (estimated)
Study startMay 2012
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01560234
Sponsor's protocol ID: D0542C00001
Other IDs: Eudract number 2011-005986-20
Status last verified: Apr 2016
First submitted: 20 Mar 2012
Last updated: 6 Jun 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Delaney S, Biffen M, Maltby J, Bell J, Asimus S, Aggarwal A, Kraan M, Keeling D. Tolerability in man following inhalation dosing of the selective TLR7 agonist, AZD8848. BMJ Open Respir Res. 2016 Feb 23;3(1):e000113. doi: 10.1136/bmjresp-2015-000113. eCollection 2016.
PubMed 26933507

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD8848 in Healthy Subjects
ClinicalTrials.gov ID: NCT01560234
Acronym / sponsor ID: D0542C00001
Conditions: Healthy
Keywords: Safety, tolerability, healthy, pharmacokinetic, pharmacodynamic, inhaled
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 22 Mar 2012 (estimated)
Results: Posted 6 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of AZD8848 in healthy subjects.

Detailed description

A Double-blind, Placebo-controlled, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD8848 in Healthy Subjects

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AZD8848	Experimental	Drug: AZD8848
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy men or women aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
Women can be of childbearing potential and must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 (screening) and be willing to continue on the chosen contraceptive method
Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the day of the investigational product administration until 3 months
Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Ability to produce sputum of good enough quality for assessment of biomarkers

Key exclusion criteria (5 listed)

Abnormal vital signs, after 10 minutes supine rest, defined as any of the following (SBP > 140 mmHg, Diastolic blood pressure (DBP) > 90 mmHg, Heart rate < 40 or > 85 beats per minute)
Prolonged QTcF > 450 ms or shortened QTcF < 340 ms or family history of long QT syndrome
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class as AZD8848
History of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT syndrome, or sudden death)
History of asthma or allergic rhinitis

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
AZD8848Single dose, oral inhalation (nebuliser solution)	Drug	AZD8848
PlaceboSingle dose, oral inhalation (nebuliser solution)	Drug	Placebo

Primary outcome

Adverse Events
Time frame: Screening up to Day 13
Summary of number of subjects who had at least one adverse event
Summary for Lymphocytes Laboratory Results
Time frame: Baseline, Day 1, Day 2, Day 3, and Follow up (up to Day 13)

6 secondary outcomes

Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC (Nmol*h/L)
Time frame: On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h
Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC(0-t) (Nmol*h/L)
Time frame: On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h
Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - Cmax (Nmol/L)
Time frame: On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h
Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma
Time frame: Baseline, 24 Hours.
Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma
Time frame: Baseline, 48 Hours
Statistical Assessment of CXCL10 Ratio-to-baseline- Sputum
Time frame: Baseline, 24 Hours.

Results and safety

Results posted to the registry on 6 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	16	13
Cohort 1	4	4
Cohort 2	4	3
Cohort 3	3	3
Cohort 4	4	4
Cohort 5	4	2
Cohort 7	4	4
Cohort 6 and 8	8	6

Primary outcome: Adverse Events

Time frame: Screening up to Day 13. Number. Unit: participants

Measure	Placebo n = 16	Cohort 1 n = 4	Cohort 2 n = 4	Cohort 3 n = 3	Cohort 4 n = 4	Cohort 5 n = 4	Cohort 7 n = 4	Cohort 6 and 8 n = 8
Value	6	2	1	0	3	1	2	4

Population analysed: Safety Analysis Set

Primary outcome: Summary for Lymphocytes Laboratory Results

Time frame: Baseline, Day 1, Day 2, Day 3, and Follow up (up to Day 13). Mean (Standard Deviation). Unit: cells*10^9/L

Measure	Placebo n = 16	Cohort 1 n = 4	Cohort 2 n = 4	Cohort 3 n = 3	Cohort 4 n = 4	Cohort 5 n = 4	Cohort 7 n = 4	Cohort 6 and 8 n = 8
Baseline	1.6 (0.3)	1.7 (0.5)	2.0 (0.6)	2.1 (0.5)	2.3 (0.7)	2.1 (0.3)	1.9 (0.3)	1.6 (0.3)
Day 1	2.3 (0.5)	2.1 (0.7)	2.7 (0.7)	2.2 (0.3)	2.4 (0.6)	2.4 (0.6)	2.0 (0.4)	1.4 (0.6)
Day 2	1.6 (0.4)	2.0 (0.6)	1.9 (0.3)	2.0 (1.5)	2.2 (0.7)	2.0 (0.3)	1.4 (0.3)	0.9 (0.2)
Day 3	1.8 (0.5)	2.0 (0.6)	2.1 (0.2)	2.0 (0.6)	2.3 (1.0)	2.0 (0.1)	1.7 (0.1)	1.4 (0.2)
Follow up (up to Day 13)	1.7 (0.4)	2.0 (0.5)	2.1 (0.5)	1.8 (0.3)	2.1 (0.8)	1.9 (0.2)	1.7 (0.3)	1.5 (0.4)

Population analysed: Safety Analysis Set

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening up to 11 - 13 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 16 (0%)	6 of 16 (37.5%)	Not reported
Cohort 1	0 of 4 (0%)	2 of 4 (50%)	Not reported
Cohort 2	0 of 4 (0%)	1 of 4 (25%)	Not reported
Cohort 3	0 of 3 (0%)	0 of 3 (0%)	Not reported
Cohort 4	1 of 4 (25%)	3 of 4 (75%)	Not reported
Cohort 5	0 of 4 (0%)	1 of 4 (25%)	Not reported
Cohort 7	0 of 4 (0%)	2 of 4 (50%)	Not reported
Cohort 6 and 8	0 of 4 (0%)	4 of 8 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26933507Delaney S, Biffen M, Maltby J, Bell J, Asimus S, Aggarwal A, Kraan M, Keeling D. Tolerability in man following inhalation dosing of the selective TLR7 agonist, AZD8848. BMJ Open Respir Res. 2016 Feb 23;3(1):e000113. doi: 10.1136/bmjresp-2015-000113. eCollection 2016.
CSR SynopsisLink provided by the sponsor.

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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.

Ajay Aggarwal study director

AstraZeneca R&D, 35 Gatehouse Drive, MA 02451 USA

James Ritter, BA,MA D Phil,BM BCh,MRCP,FRCP principal investigator

Quintile Drug Research Unit at Guy's Hospital Quintiles Ltd 6 Newcomen Street London SE1 1YR United Kingdom

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, run by AstraZeneca at 1 site in United Kingdom.

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 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 6 Jun 2016. 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 Kingdom. 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?

Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (time frame: Screening up to Day 13). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01560234, which also lists 1 linked publication.

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 6 Jun 2016.