PsoriasisPhase 1NCT01899755
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability, Immunogenicity, and Pharmacodynamics (PD) of GSK2800528 in Healthy Subjects.
A Phase 1 study testing GSK2800528, solution for injection and Adalimumab, solution for injection in people with Psoriasis, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
GSK2800528 is being developed as a human anti-tumor necrosis factor (TNF) alpha monoclonal antibody (mAb) for the treatment of immune-inflammatory diseases. The study will be conducted in healthy volunteers and divided into 4 cohorts. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- GSK2800528, solution for injection and Adalimumab, solution for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2013to 3 Apr 2014
- 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
- ALT, alkaline phosphatase and bilirubin <= 1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Average bazett's corrected QT interval (QTcB) < 450 msec, or QTcB < 480 msec in subjects with Bundle Branch Block.
- 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 clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included at the investigator's discretion provided the finding is unlikely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study procedures.
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 21.7 international unit/liter (IU/L) and oestradiol <110 picomoles/liter (pmol/L) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods specified in study protocol.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods specified in study protocol.
- Body weight >= 60 kg and body mass index (BMI) within the range 19 to 31 kilogram/meter2 (kg/m2) (inclusive).
Who cannot join
- A positive pre-study Quantiferon test, Hepatitis B surface antigen, or positive Hepatitis C antibody result within 3 months of screening.
- Current or chronic history of liver or kidney disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- Previous treatment with adalimumab.
- Current, or history of, cancer.
Show all 17Show fewer
- 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 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- 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: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Travel to regions of high endemic tuberculosis/infection, as judged by the investigator or medical monitor, is prohibited from the start of screening until the final follow up visit.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- 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.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- Current evidence or history of bacterial, viral, or fungal infection within 7 days before dosing.
- Subject has received any type of vaccination within 21 days before dosing or will require vaccination prior to the end of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Pharmacokinetics, Safety and Tolerability, Immunogenicity, and Pharmacodynamics of GSK2800528 in Healthy Subjects.
GSK2800528 is being developed as a human anti-tumor necrosis factor (TNF) alpha monoclonal antibody (mAb) for the treatment of immune-inflammatory diseases. The study will be conducted in healthy volunteers and divided into 4 cohorts. Cohorts 1 to 3 will consist of groups of 12 subjects, 9 on active treatment (GSK2800528), and 3 on placebo. Cohort 4 will consist of a group of 9 subjects, all on active treatment (adalimumab).
- Conditions
- Psoriasis
- Being tested
- GSK2800528, solution for injection, Placebo (0.9% w/v Sodium Chloride), solution for injection, Adalimumab, solution for injection
- Keywords
- monoclonal antibody, healthy volunteer, TNF alpha
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2800528, solution for injectionDrug
Drug will be administered at 3 different dose levels by subcutaneous injection.
Placebo (0.9% w/v Sodium Chloride), solution for injectionDrug
Subcutaneous injection of. 0.8 mL solution will be administered
Adalimumab, solution for injectionDrug
Subcutaneous injection of 0.8 mL solution will be administered (40mg)
| Study group | Role | What they receive |
|---|---|---|
| GSK2800528 Arm | Experimental | Subjects will be assigned to treatments in accordance with the randomization schedule in Cohorts 1 to 3. Treatments will be randomized with placebo in a 3:1 ratio. The final randomization code will also pre-define the sentinel subjects to ensure that of the first two subjects in each cohort, one will receive GSK2800528 and the other will receive placebo. Receives: Drug: GSK2800528, solution for injection |
| Placebo Arm | Placebo comparator | Subjects will be assigned to treatments in accordance with the randomization schedule in Cohorts 1 to 3. Treatments will be randomized with placebo in a 3:1 ratio. The final randomization code will also pre-define the sentinel subjects to ensure that of the first two subjects in each cohort, one will receive GSK2800528 and the other will receive placebo. Receives: Drug: Placebo (0.9% w/v Sodium Chloride), solution for injection |
| Adalimumab Arm | Active comparator | In Cohort 4, all subjects will receive adalimumab 40 mg (0.8 mL solution) as subcutaneous injection Receives: Drug: Adalimumab, solution for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparent systemic clearance (CL/F) of GSK2800528
Measured: Up to Day 196
Apparent systemic clearance (CL/F) of adalimumab
Measured: Up to Day 140
Adverse event (AE) and Serious Adverse event (SAE) reporting
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. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function.
Measured: Up to Day 196
Laboratory safety assessment for clinical chemistry parameters
Safety data for laboratory clinical chemistry parameters including albumin, creatinine, glucose, sodium, potassium, chloride, calcium, total protein, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatise, total and direct bilirubin, and uric acid will be assessed
Measured: Up to Day 196
Laboratory safety assessment for hematology parameters
Safety data for laboratory hematology parameters including platelet count, red blood cell (RBC) count, absolute white blood cell (WBC) count, reticulocyte count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular haemoglobin concentration (MCHC), mean corpuscular haemoglobin (MCH), neutrophils, lymphocytes, monocytes, eosinophils, and basophils will be assessed.
Measured: Up to Day 196
Laboratory safety assessment for urinalysis parameters
Safety data for laboratory urinalysis parameters including specific gravity, pH, glucose, protein, blood and ketones by dipstick , and microscopic examination will be assessed
Measured: Up to Day 196
Vital signs monitoring (blood pressure, heart rate, body temperature)
Safety data for vital signs including blood pressure, heart rate, and body temperature will be measured
Measured: Up to Day 196
Electrocardiogram (ECG) monitoring
Supine 12-lead ECG data will be monitored
Measured: Up to Day 196
Secondary outcomes (5)
Plasma concentrations of GSK2800528 and derived pharmacokinetic parameters other than CL/F
Blood samples for PK analysis of GSK2800528 will be collected to assess plasma concentration and derived PK parameters including maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration time curve [AUC(0-t) and AUC(0-infinity)], and apparent terminal phase half-life (t1/2)
Measured: Up to Day 196
Plasma concentrations of adalimumab and derived pharmacokinetic parameters other than CL/F
Blood samples for PK analysis of adalimumab will be collected to assess plasma concentration and derived PK parameters including Cmax, tmax, AUC(0-t) and AUC(0-infinity), and t1/2
Measured: Up to Day 140
Incidence, titers, and specificity of anti-GSK2800528 antibodies.
Measured: Up to Day 196
Incidence, titers, and specificity of anti-adalimumab antibodies
Measured: Up to Day 140
Neutralising activity for samples with confirmed anti-drug antibodies
Measured: Up to Day 196
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study start10 Jul 2013
- Primary completion3 Apr 2014
- Study completion3 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899755
- Sponsor's protocol ID
- 116987
- Status last verified
- May 2017
- First submitted
- 11 Jul 2013
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Pharmacokinetics, Safety and Tolerability, Immunogenicity, and Pharmacodynamics of GSK2800528 in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01899755
- Acronym / sponsor ID
- 116987
- Conditions
- Psoriasis
- Keywords
- monoclonal antibody, healthy volunteer, TNF alpha
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2013 (actual)
- Primary completion
- 3 Apr 2014 (actual)
- Study completion
- 3 Apr 2014 (actual)
- First posted
- 15 Jul 2013 (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.
GSK2800528 is being developed as a human anti-tumor necrosis factor (TNF) alpha monoclonal antibody (mAb) for the treatment of immune-inflammatory diseases. The study will be conducted in healthy volunteers and divided into 4 cohorts. Cohorts 1 to 3 will consist of groups of 12 subjects, 9 on active treatment (GSK2800528), and 3 on placebo. Cohort 4 will consist of a group of 9 subjects, all on active treatment (adalimumab).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GSK2800528 Arm | Experimental | Drug: GSK2800528, solution for injectionSubjects will be assigned to treatments in accordance with the randomization schedule in Cohorts 1 to 3. Treatments will be randomized with placebo in a 3:1 ratio. The final randomization code will also pre-define the sentinel subjects to ensure that of the first two subjects in each cohort, one will receive GSK2800528 and the other will receive placebo. |
| Placebo Arm | Placebo comparator | Drug: Placebo (0.9% w/v Sodium Chloride), solution for injectionSubjects will be assigned to treatments in accordance with the randomization schedule in Cohorts 1 to 3. Treatments will be randomized with placebo in a 3:1 ratio. The final randomization code will also pre-define the sentinel subjects to ensure that of the first two subjects in each cohort, one will receive GSK2800528 and the other will receive placebo. |
| Adalimumab Arm | Active comparator | Drug: Adalimumab, solution for injectionIn Cohort 4, all subjects will receive adalimumab 40 mg (0.8 mL solution) as subcutaneous injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ALT, alkaline phosphatase and bilirubin <= 1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Average bazett's corrected QT interval (QTcB) < 450 msec, or QTcB < 480 msec in subjects with Bundle Branch Block.
- 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 clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included at the investigator's discretion provided the finding is unlikely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study procedures.
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 21.7 international unit/liter (IU/L) and oestradiol <110 picomoles/liter (pmol/L) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods specified in study protocol.
Key exclusion criteria (17 listed)
- A positive pre-study Quantiferon test, Hepatitis B surface antigen, or positive Hepatitis C antibody result within 3 months of screening.
- Current or chronic history of liver or kidney disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- Previous treatment with adalimumab.
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 |
|---|---|---|
| GSK2800528, solution for injectionDrug will be administered at 3 different dose levels by subcutaneous injection. | Drug | GSK2800528 Arm |
| Placebo (0.9% w/v Sodium Chloride), solution for injectionSubcutaneous injection of. 0.8 mL solution will be administered | Drug | Placebo Arm |
| Adalimumab, solution for injectionSubcutaneous injection of 0.8 mL solution will be administered (40mg) | Drug | Adalimumab Arm |
Primary outcome
Apparent systemic clearance (CL/F) of GSK2800528
Time frame: Up to Day 196
Apparent systemic clearance (CL/F) of adalimumab
Time frame: Up to Day 140
Adverse event (AE) and Serious Adverse event (SAE) reporting
Time frame: Up to Day 196
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. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function.
Laboratory safety assessment for clinical chemistry parameters
Time frame: Up to Day 196
Safety data for laboratory clinical chemistry parameters including albumin, creatinine, glucose, sodium, potassium, chloride, calcium, total protein, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatise, total and direct bilirubin, and uric acid will be assessed
Laboratory safety assessment for hematology parameters
Time frame: Up to Day 196
Safety data for laboratory hematology parameters including platelet count, red blood cell (RBC) count, absolute white blood cell (WBC) count, reticulocyte count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular haemoglobin concentration (MCHC), mean corpuscular haemoglobin (MCH), neutrophils, lymphocytes, monocytes, eosinophils, and basophils will be assessed.
Laboratory safety assessment for urinalysis parameters
Time frame: Up to Day 196
Safety data for laboratory urinalysis parameters including specific gravity, pH, glucose, protein, blood and ketones by dipstick , and microscopic examination will be assessed
Vital signs monitoring (blood pressure, heart rate, body temperature)
Time frame: Up to Day 196
Safety data for vital signs including blood pressure, heart rate, and body temperature will be measured
Electrocardiogram (ECG) monitoring
Time frame: Up to Day 196
Supine 12-lead ECG data will be monitored
5 secondary outcomes
Plasma concentrations of GSK2800528 and derived pharmacokinetic parameters other than CL/F
Time frame: Up to Day 196
Plasma concentrations of adalimumab and derived pharmacokinetic parameters other than CL/F
Time frame: Up to Day 140
Incidence, titers, and specificity of anti-GSK2800528 antibodies.
Time frame: Up to Day 196
Incidence, titers, and specificity of anti-adalimumab antibodies
Time frame: Up to Day 140
Neutralising activity for samples with confirmed anti-drug antibodies
Time frame: Up to Day 196
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 11 May 2017.
- Results for study 116987 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 GSK2800528, solution for injection and Adalimumab, solution for injection in people with Psoriasis, 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 7 inclusion and 17 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 11 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?
Apparent systemic clearance (CL/F) of GSK2800528 (time frame: Up to Day 196). The study lists 8 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 11 May 2017.