Autoimmune DiseasesPhase 1NCT02293161

Single Ascending Doses Study of Anti- Interleukin-7 Receptor α Monoclonal Antibody (GSK2618960) in Healthy Volunteers

A Phase 1 study testing GSK2618960 in people with Autoimmune Diseases, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Autoimmune Diseases
What is being tested?: GSK2618960
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteUnited Kingdom
Study dates: 11 Nov 2014to 1 Sep 2015
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Males aged between 18 and 65 years of age inclusive, at the time of signing the informed consent OR females of non-child bearing potential aged between 18 and 65 years of age at the time of signing the informed consent.
Non-childbearing potential defined as:- pre-menopausal females with a documented tubal ligation or hysterectomy, or post-menopausal defined as 24 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli-international units (MIU) per millilitre (mL) and oestradiol <40 picograms (pg) /mL (< 140 picomole/liter) is confirmatory. [Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt must discontinue HRT to allow confirmation of postmenopausal status prior to study enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their postmenopausal status, they can resume use of HRT during the study.]
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Protocol. This criterion must be followed from the time of the first dose of study medication until 5 half-lives after the infusion (Week 16 visit).
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinically significant abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the local reference range being used for healthy volunteers may be included only if the Investigator in consultation with the GSK Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
White blood cell count >=Lower Limit of Normal (LLN), including both lymphocyte and neutrophil counts >=LLN.
Body weight >=50 kilogram (kg) and body mass index (BMI) within the range 19.0 - 32.0 kilogram / square meter (kg/m^2) (inclusive).
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Subjects with a confirmed positive vaccination status for tetanus, diphtheria, pertussis, measles, mumps, rubella, pneumococcus and meningococcus (or consent to vaccination)

Who cannot join

Criteria Based Upon Medical Histories
Current evidence of ongoing or acute infection within 3 months prior to the first dose of study drug, such as: serious local infection (e.g. cellulitis, abscess); systemic infection [e.g. pneumonia, septicaemia, Tuberculosis (TB)].
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
A QT duration corrected for heart rate by Fridericia's formula (QTcF) >450 millisecond (msec) based on either single or averaged QTcF values of triplicate ECGs obtained over a brief recording period.
History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint ~240 mL of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.

Show all 18Show fewer

Previous history of anaphylaxis and severe allergic reaction.
Receipt of live vaccination within 1 month of screening or plan to receive live vaccination at any time during the study i.e. 6 months following dosing (which covers the period when the predicted target duration of receptor occupancy is >= 95%).
Subjects from a high risk area of the world for tuberculosis or have history of tuberculosis or have close family members with confirmed TB infection or positive at screening by Quantiferon testing (an indeterminate test result at screen may be repeated once).
Criteria Based Upon Diagnostic Assessments
A positive pre-study Hepatitis B surface and/or core antibody or positive Hepatitis C antibody result within 3 months of screening
A positive pre-study drug screen.
A positive test for Human Immunodeficiency Virus (HIV) antibody. Other Criteria
Smokers who would not be able to refrain from smoking whilst in the phase I unit.
Unable to refrain from the use of prescription or non-prescription drugs (unless permitted as per protocol
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day "rolling" period.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
Cambridge, CB2 2GG

Other trials in United Kingdom

About this study

Official title: A Randomised, Double-Blind (Sponsor Unblind), Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Single Ascending Doses of a Fully Humanized Anti-IL-7 Receptor α Monoclonal Antibody (GSK2618960) in Healthy Volunteers

GSK2618960 is a humanized Immunoglobulin G 1 ( IgG1) monoclonal antibody (mAb) that binds to the alpha component (CD127) of the heterodimeric Interleukin-7 receptor (IL-7R). It is being developed for the treatment of autoimmune indications. This study is intended to further explore the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of single ascending doses GSK2618960 in healthy volunteers beyond those already evaluated in I7R116702 (First Time In Human study). The study is anticipated to enrol 18 subjects in total, with 9 subjects in each of the two cohorts.

Conditions: Autoimmune Diseases
Being tested: GSK2618960, Placebo
Keywords: Interleukin-7 Receptor α, monoclonal antibody
Medical subject headings: Autoimmune Diseases

What participants receive

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

GSK2618960Drug
GSK2618960 will be provided as 100 mg/mL solution for injection to be administered as single dose IV infusion that has to be diluted at the study site with placebo
PlaceboDrug
It is Sodium Chloride Intravenous Infusion

Study groups in NCT02293161
Study group	Role	What they receive
Cohort A GSK2618960	Experimental	Subjects will receive GSK2618960 0.6 milligram per kilogram (mg/kg) Receives: Drug: GSK2618960
Cohort A Placebo	Placebo comparator	Subjects will receive Sodium Chloride Intravenous as placebo Receives: Drug: Placebo
Cohort B GSK2618960	Experimental	Subjects will receive GSK2618960,planned dose being 2mg/kg. However, actual dose level for Cohort B may be adjusted based on the emerging data on safety, tolerability, PK and RO from Cohort A. The maximum dose will not exceed 2.4 mg/kg (i.e. a 4-fold dose escalation from 0.6 mg/kg) Receives: Drug: GSK2618960
Cohort B Placebo	Placebo comparator	Subjects will receive Sodium Chloride Intravenous as placebo Receives: Drug: Placebo

What is being measured

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

Number of Participants with Adverse events (AE)
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Measured: Up to Day 169
Absolute values of vital signs
Vital signs includes systolic and diastolic blood pressure, pulse rate and body temperature.
Measured: Up to Day 169
Change from baseline in vital signs
Vital signs includes systolic and diastolic blood pressure, pulse rate and body temperature.
Measured: Baseline (Day1) and up to Day 169
Absolute values of Electrocardiogram (ECG) parameters
Single 12-lead ECGs will be obtained.
Measured: Up to Day 169
Change from baseline in ECG parameters
Single 12-lead ECGs will be obtained.
Measured: Baseline (Day1) and up to Day 169
Absolute values of haematology
Haematology parameters includes Platelet Count, Red blood cells (RBC) Count, White blood cells Count (absolute) (WBC), Haemoglobin and Haematocrit
Measured: Up to Day 169
Change from baseline in haematology
Haematology parameters includes Platelet Count, RBC, WBC, Haemoglobin and Haematocrit
Measured: Baseline (Day -1) and up to Day 169
Absolute values of clinical chemistry
Clinical chemistry includes Blood urea nitrogen, Potassium, Aspartate aminotransferase (SGOT), Total and direct bilirubin, Creatinine, Chloride, Alanine aminotransferase (SGPT), Albumin, Glucose, Total Carbon dioxide, Gamma glutamyltransferase, Total Protein, Sodium, Calcium and Alkaline phosphatase
Measured: Up to Day 169
Change from baseline in clinical chemistry
Clinical chemistry includes Blood urea nitrogen, Potassium, SGOT, Total and direct bilirubin, Creatinine, Chloride, SGPT, Albumin, Glucose, Total Carbon dioxide, Gamma glutamyltransferase, Total Protein, Sodium, Calcium and Alkaline phosphatase
Measured: Baseline (Day -1) and up to Day 169
Absolute values of urinalysis
Urinalysis includes Specific gravity, pH, glucose, protein, blood and ketones by dipstick, Microscopic examination (if blood or protein is abnormal)
Measured: Up to Day 169
Change from baseline in urinalysis
Urinalysis includes Specific gravity, pH, glucose, protein, blood and ketones by dipstick, Microscopic examination (if blood or protein is abnormal)
Measured: Baseline (Day -1) and up to Day 169

Secondary outcomes (9)

Composite of PK parameters
PK parameters includes Area Under the Concentration-time curve (AUC) from zero (pre-dose) extrapolated to infinite time (AUC[0-infinite]); AUC from time zero (pre-dose) to last quantifiable concentration within a subject across all treatments (AUC[0-t]); Percentage of AUC(0- infinite) obtained by extrapolation (%AUC-[ex]); Clearance (CL); Volume of distribution (Vss); Maximum observed concentration (Cmax); Time of occurrence of Cmax (Tmax); Terminal half life (t1/2).
Measured: Up to Day 29
Duration of full receptor occupancy (RO) for Cohort A
The extent and duration of receptor occupancy and the inhibition of IL-7 signalling in Stat5 phosphorylation (pSTAT5) will be determined
Measured: Up to Day 43
Duration of full RO for Cohort B
The extent and duration of receptor occupancy and the inhibition of IL-7 signalling in pSTAT5 will be determined
Measured: Up to Day 57
Relationship between dose/exposure and duration of full RO for Cohort A
The PD/RO relationship of GSK2618960 following single and repeat Intravenous (IV) doses will be determined.
Measured: Up to Day 43
Relationship between dose/exposure and duration of full RO for Cohort B
The PD/RO relationship of GSK2618960 following single and repeat IV doses will be determined.
Measured: Up to Day 57
Degree of blocking of IL-7R alpha signalling for Cohort A
It will be assessed by residual IL-7- and Thymic Stromal Lymphopoietin (TSLP)-mediated pSTAT5 and Thymus and Activation-Regulated Chemokine (TARC) secretion
Measured: Up to Day 43
Degree of blocking of IL-7R alpha signalling for Cohort B
It will be assessed by residual IL-7- and TSLP-mediated pSTAT5 and TARC secretion
Measured: Up to Day 57
Incidence of anti-drug antibodies (ADAs)
Blood samples will be collected for the assessment of ADAs in serum using validated electrochemiluminescent (ECL)assays
Measured: Up to Day 85
Titre of ADAs
Blood samples will be collected for the assessment of ADAs in serum using validated ECL assays
Measured: Up to Day 85

Timeline

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

11 Nov 20141 Sep 2015

First posted18 Nov 2014 (estimated)
Study start11 Nov 2014
Primary completion1 Sep 2015
Study completion1 Sep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02293161
Sponsor's protocol ID: 200902
Status last verified: May 2017
First submitted: 27 Oct 2014
Last updated: 9 May 2017
Results posted: No
Data monitoring committee: No

Publications

Ellis J, van Maurik A, Fortunato L, Gisbert S, Chen K, Schwartz A, McHugh S, Want A, Santos Franco S, Oliveira JJ, Price J, Coles A, Brown K, Su D, Craigen JL, Yang J, Brett S, Davis B, Cheriyan J, Kousin-Ezewu O, Gray F, Thompson PW, Fernando D. Anti-IL-7 receptor alpha monoclonal antibody (GSK2618960) in healthy subjects - a randomized, double-blind, placebo-controlled study. Br J Clin Pharmacol. 2019 Feb;85(2):304-315. doi: 10.1111/bcp.13748. Epub 2018 Dec 3.
PubMed 30161291

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 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-Blind (Sponsor Unblind), Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Single Ascending Doses of a Fully Humanized Anti-IL-7 Receptor α Monoclonal Antibody (GSK2618960) in Healthy Volunteers
ClinicalTrials.gov ID: NCT02293161
Acronym / sponsor ID: 200902
Conditions: Autoimmune Diseases
Keywords: Interleukin-7 Receptor α, monoclonal antibody
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 11 Nov 2014 (actual)
Primary completion: 1 Sep 2015 (actual)
Study completion: 1 Sep 2015 (actual)
First posted: 18 Nov 2014 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Cohort A GSK2618960	Experimental	Drug: GSK2618960Subjects will receive GSK2618960 0.6 milligram per kilogram (mg/kg)
Cohort A Placebo	Placebo comparator	Drug: PlaceboSubjects will receive Sodium Chloride Intravenous as placebo
Cohort B GSK2618960	Experimental	Drug: GSK2618960Subjects will receive GSK2618960,planned dose being 2mg/kg. However, actual dose level for Cohort B may be adjusted based on the emerging data on safety, tolerability, PK and RO from Cohort A. The maximum dose will not exceed 2.4 mg/kg (i.e. a 4-fold dose escalation from 0.6 mg/kg)
Cohort B Placebo	Placebo comparator	Drug: PlaceboSubjects will receive Sodium Chloride Intravenous as placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Males aged between 18 and 65 years of age inclusive, at the time of signing the informed consent OR females of non-child bearing potential aged between 18 and 65 years of age at the time of signing the informed consent.
Non-childbearing potential defined as:- pre-menopausal females with a documented tubal ligation or hysterectomy, or post-menopausal defined as 24 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli-international units (MIU) per millilitre (mL) and oestradiol <40 picograms (pg) /mL (< 140 picomole/liter) is confirmatory. [Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt must discontinue HRT to allow confirmation of postmenopausal status prior to study enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their postmenopausal status, they can resume use of HRT during the study.]
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Protocol. This criterion must be followed from the time of the first dose of study medication until 5 half-lives after the infusion (Week 16 visit).
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinically significant abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the local reference range being used for healthy volunteers may be included only if the Investigator in consultation with the GSK Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
White blood cell count >=Lower Limit of Normal (LLN), including both lymphocyte and neutrophil counts >=LLN.

Key exclusion criteria (18 listed)

Criteria Based Upon Medical Histories
Current evidence of ongoing or acute infection within 3 months prior to the first dose of study drug, such as: serious local infection (e.g. cellulitis, abscess); systemic infection [e.g. pneumonia, septicaemia, Tuberculosis (TB)].
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
A QT duration corrected for heart rate by Fridericia's formula (QTcF) >450 millisecond (msec) based on either single or averaged QTcF values of triplicate ECGs obtained over a brief recording period.
History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint ~240 mL of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.

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
GSK2618960GSK2618960 will be provided as 100 mg/mL solution for injection to be administered as single dose IV infusion that has to be diluted at the study site with placebo	Drug	Cohort A GSK2618960, Cohort B GSK2618960
PlaceboIt is Sodium Chloride Intravenous Infusion	Drug	Cohort A Placebo, Cohort B Placebo

Primary outcome

Number of Participants with Adverse events (AE)
Time frame: Up to Day 169
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Absolute values of vital signs
Time frame: Up to Day 169
Vital signs includes systolic and diastolic blood pressure, pulse rate and body temperature.
Change from baseline in vital signs
Time frame: Baseline (Day1) and up to Day 169
Vital signs includes systolic and diastolic blood pressure, pulse rate and body temperature.
Absolute values of Electrocardiogram (ECG) parameters
Time frame: Up to Day 169
Single 12-lead ECGs will be obtained.
Change from baseline in ECG parameters
Time frame: Baseline (Day1) and up to Day 169
Single 12-lead ECGs will be obtained.
Absolute values of haematology
Time frame: Up to Day 169
Haematology parameters includes Platelet Count, Red blood cells (RBC) Count, White blood cells Count (absolute) (WBC), Haemoglobin and Haematocrit
Change from baseline in haematology
Time frame: Baseline (Day -1) and up to Day 169
Haematology parameters includes Platelet Count, RBC, WBC, Haemoglobin and Haematocrit
Absolute values of clinical chemistry
Time frame: Up to Day 169
Clinical chemistry includes Blood urea nitrogen, Potassium, Aspartate aminotransferase (SGOT), Total and direct bilirubin, Creatinine, Chloride, Alanine aminotransferase (SGPT), Albumin, Glucose, Total Carbon dioxide, Gamma glutamyltransferase, Total Protein, Sodium, Calcium and Alkaline phosphatase
Change from baseline in clinical chemistry
Time frame: Baseline (Day -1) and up to Day 169
Clinical chemistry includes Blood urea nitrogen, Potassium, SGOT, Total and direct bilirubin, Creatinine, Chloride, SGPT, Albumin, Glucose, Total Carbon dioxide, Gamma glutamyltransferase, Total Protein, Sodium, Calcium and Alkaline phosphatase
Absolute values of urinalysis
Time frame: Up to Day 169
Urinalysis includes Specific gravity, pH, glucose, protein, blood and ketones by dipstick, Microscopic examination (if blood or protein is abnormal)
Change from baseline in urinalysis
Time frame: Baseline (Day -1) and up to Day 169
Urinalysis includes Specific gravity, pH, glucose, protein, blood and ketones by dipstick, Microscopic examination (if blood or protein is abnormal)

9 secondary outcomes

Composite of PK parameters
Time frame: Up to Day 29
Duration of full receptor occupancy (RO) for Cohort A
Time frame: Up to Day 43
Duration of full RO for Cohort B
Time frame: Up to Day 57
Relationship between dose/exposure and duration of full RO for Cohort A
Time frame: Up to Day 43
Relationship between dose/exposure and duration of full RO for Cohort B
Time frame: Up to Day 57
Degree of blocking of IL-7R alpha signalling for Cohort A
Time frame: Up to Day 43
Degree of blocking of IL-7R alpha signalling for Cohort B
Time frame: Up to Day 57
Incidence of anti-drug antibodies (ADAs)
Time frame: Up to Day 85
Titre of ADAs
Time frame: Up to Day 85

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 9 May 2017.
Derived from this study: PubMed 30161291Ellis J, van Maurik A, Fortunato L, Gisbert S, Chen K, Schwartz A, McHugh S, Want A, Santos Franco S, Oliveira JJ, Price J, Coles A, Brown K, Su D, Craigen JL, Yang J, Brett S, Davis B, Cheriyan J, Kousin-Ezewu O, Gray F, Thompson PW, Fernando D. Anti-IL-7 receptor alpha monoclonal antibody (GSK2618960) in healthy subjects - a randomized, double-blind, placebo-controlled study. Br J Clin Pharmacol. 2019 Feb;85(2):304-315. doi: 10.1111/bcp.13748. Epub 2018 Dec 3.
Results for study 200902 can be found on the GSK Clinical Study Register.Link 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.

GSK Clinical Trials study director

GlaxoSmithKline

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 GSK2618960 in people with Autoimmune Diseases, run by GlaxoSmithKline 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 8 inclusion and 18 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 9 May 2017. 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?

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?

Number of Participants with Adverse events (AE) (time frame: Up to Day 169). The study lists 11 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 NCT02293161, 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 9 May 2017.