Healthy SubjectsPhase 1NCT01958645

To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses.

A Phase 1 study testing MEDI8111 in people with Healthy Subjects, 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

A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single ascending doses in healthy male. Read more about this study

Who is it for?: Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: MEDI8111
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 157 participants
Where: 1 siteUnited Kingdom
Study dates: Nov 2013to Oct 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 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures, Healthy male subjects aged 18-40 years with suitable veins for cannulation or repeated venepuncture, Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weight at least 50 kg an no more than 100 kg inclusive, Male subjects should be willing to avoid fathering a child by either true abstinence or the use of two effective means of contraception from the day of dosing until 3 months after dosing with the IP. They should also be willing to use barrier methods from the day of dosing until 3 months after dosing.

Who cannot join

Prothrombotic mutation such as factor V Leiden, or deficiencies of protein C, protein S, prothrombin, antithrombin or APC, Antibodies to coagulation FII, History or family history of venous or arterial thromboembolic event, and/or myocardial infarction before age of 50 years, ETP level at baseline >2000nM/min, FII level (by clot) at screening and/or at baseline outside 50-250% of the normal range

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 Phase I, Single-blind, Randomised, Placebo-controlled, Single Centre Study to Investigate the Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses in Healthy Male Subjects

A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single ascending doses in healthy male.

Read the detailed description

A phase I, single-blind, randomised, placebo-controlled, single centre study to investigate the safety, tolerability and pharmacodynamics of intravenous MEDI8111 after single ascending doses in healthy male subjects.

Conditions: Healthy Subjects
Being tested: MEDI8111, Placebo
Keywords: Phase 1, healthy male subjects, safety and tolerability, pharmacodynamic, pharmacokinetic

What participants receive

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

MEDI8111Drug
MEDI8111 lyophilisate for solution for infusion
PlaceboOther
Placebo for MEDI8111 saline solution for infusion

Study groups in NCT01958645
Study group	Role	What they receive
A	Experimental	MEDI8111 Receives: Drug: MEDI8111
B	Placebo comparator	Placebo for MEDI8111 Receives: Other: Placebo

What is being measured

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

Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
Measured: From screening and up to the lab follow-up visit (Day 29)

Secondary outcomes (4)

Change From Baseline Endogenous Thrombin Potential (ETP)
For the baseline variables and adverse events the two placebo arms (placebo dose 1 and placebo dose 2) are recorded as one. For the secondary outcome measures the two placebo arms are recorded separately.
Measured: Predose and Days 1-5
Change From Baseline Factor II Concentrations by ECL Assay
Measured: Predose and 1-8 hours
Change From Baseline Factor II Concentrations by Clot Assay
Measured: Predose and 1-8 hours
Change From Baseline D-dimer Concentration
Measured: predose and 1-8 hours

Timeline

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

Nov 2013Oct 2014

First posted9 Oct 2013 (estimated)
Study startNov 2013
Primary completionOct 2014
Study completionOct 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.
Other trials for Healthy SubjectsStudies 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: 157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01958645
Sponsor's protocol ID: D5050C00001
Status last verified: Dec 2015
First submitted: 7 Oct 2013
Last updated: 4 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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All Healthy Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Single-blind, Randomised, Placebo-controlled, Single Centre Study to Investigate the Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses in Healthy Male Subjects
ClinicalTrials.gov ID: NCT01958645
Acronym / sponsor ID: D5050C00001
Conditions: Healthy Subjects
Keywords: Phase 1, healthy male subjects, safety and tolerability, pharmacodynamic, pharmacokinetic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 157 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 9 Oct 2013 (estimated)
Results: Posted 4 Feb 2016

Clinical summary

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

A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single ascending doses in healthy male.

Detailed description

Study design

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

Arm	Type	Receives
A	Experimental	Drug: MEDI8111MEDI8111
B	Placebo comparator	Other: PlaceboPlacebo for MEDI8111

Who may qualify

Ages: 18 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures, Healthy male subjects aged 18-40 years with suitable veins for cannulation or repeated venepuncture, Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weight at least 50 kg an no more than 100 kg inclusive, Male subjects should be willing to avoid fathering a child by either true abstinence or the use of two effective means of contraception from the day of dosing until 3 months after dosing with the IP. They should also be willing to use barrier methods from the day of dosing until 3 months after dosing.

Key exclusion criteria (1 listed)

Prothrombotic mutation such as factor V Leiden, or deficiencies of protein C, protein S, prothrombin, antithrombin or APC, Antibodies to coagulation FII, History or family history of venous or arterial thromboembolic event, and/or myocardial infarction before age of 50 years, ETP level at baseline >2000nM/min, FII level (by clot) at screening and/or at baseline outside 50-250% of the normal range

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
MEDI8111MEDI8111 lyophilisate for solution for infusion	Drug	A
PlaceboPlacebo for MEDI8111 saline solution for infusion	Other	B

Primary outcome

Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
Time frame: From screening and up to the lab follow-up visit (Day 29)

4 secondary outcomes

Change From Baseline Endogenous Thrombin Potential (ETP)
Time frame: Predose and Days 1-5
Change From Baseline Factor II Concentrations by ECL Assay
Time frame: Predose and 1-8 hours
Change From Baseline Factor II Concentrations by Clot Assay
Time frame: Predose and 1-8 hours
Change From Baseline D-dimer Concentration
Time frame: predose and 1-8 hours

Results and safety

Results posted to the registry on 4 Feb 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	4	4
MEDI8111 Dose 1	4	4
MEDI8111 Dose 2	4	4

Primary outcome: Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination

Time frame: From screening and up to the lab follow-up visit (Day 29). Number. Unit: Participants

Measure	Placebo n = 4	MEDI8111 Dose 1 n = 4	MEDI8111 Dose 2 n = 4
Subjects with any AE	2	3	2
Gastrointestinal disorders	1	1	1
Infections and infestations	0	1	1
Investigations	0	1	0
Musculoskeletal and connective tissue disorders	0	1	0
Nervous system disorder	0	1	0
Respiratory, thoracic and mediastinal disorders	1	0	1
Skin and subcutaneous tissue disorders	1	0	0

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: At screening, Days 1-5. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 4 (0%)	2 of 4 (50%)	Not reported
MEDI8111 Dose 1	0 of 4 (0%)	3 of 4 (75%)	Not reported
MEDI8111 Dose 2	0 of 4 (0%)	2 of 4 (50%)	Not reported

Limitations and caveats (from the sponsor): Limitations: few subjects, high variability of coagulation variables

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Karin Wahlander, MD study director

AstraZeneca Mölndal, Sweden

Anders Berggren, MD study chair

AstraZeneca Mölndal, Sweden

Timothy Mant, Prof principal investigator

Quintiles London, 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 MEDI8111 in people with Healthy Subjects, 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 1 inclusion and 1 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 4 Feb 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 4 Feb 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?

Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination (time frame: From screening and up to the lab follow-up visit (Day 29)). 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 NCT01958645.

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 4 Feb 2016.