Arthritis, RheumatoidPhase 1NCT00539760
A Phase I Rheumatoid Arthritis Study in Healthy Volunteers
A Phase 1 study testing GSK1827771 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 2 sites in United States.
Trial summary
GSK182771 is a domain antibody targeting the interleukin (IL)-1 receptor which is being developed for the treatment of rheumatoid arthritis. This study is being done in healthy volunteers to verify the safety and tolerability of GSK182771 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- GSK1827771
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Sep 2007to 5 Apr 2008
- 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 adult men or women as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests and cardiac assessment.
- Female subjects of non-childbearing potential.
- Male subjects must agree to abstain from or agree to use adequate contraception, in addition to having their female partner use another form of contraception. This criterion must be followed from the time of the first dose of study medication until Pharmacokinetic levels are determined to be below the LLQ.
- Men or women who are between 18 and 55 years of age, inclusive.
- Body Mass Index (BMI) within the range of 18-35 kilogram per meter square (kg/m^2) inclusive.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Who cannot join
- The subject has a positive pre-study urine drug/urine alcohol screen. A minimum list of drugs that will be screened for includes amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A history of regular alcohol consumption averaging >7 drinks/week for females or >14 drinks/week for males. One drink is equivalent to (12 g alcohol) = 5 ounces [150 milliliter (mL)] of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits
- The subject is unwilling to abstain from alcohol consumption from 48 hour prior to dosing until discharge from the clinic, and for 48 hour prior to all other out-patient clinic visits.
- Smoked or used tobacco or nicotine-containing products within the previous 6 months prior to the first dose of current study medication.
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
- Previous exposure to or treatment with PEGylated molecules.
Show all 27Show fewer
- Use of anti-Tumor Necrosis Factor (anti-TNF) drugs within 60 days prior to dosing.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days , 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 (including antibiotics) which, in the opinion of the investigator and/or GSK Medical Monitor, contraindicates the subject's participation.
- Positive pregnancy test at Screening or on Day -1 (females only).
- Any clinically significant abnormality identified on the screening medical assessment or examination, or ECG.
- Any white blood cell (WBC) or neutrophil count outside the normal range at screening or on Day -1.
- History of significant cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions that in the opinion of the investigator and/or GSK Medical Monitor, places the subject at an unacceptable risk as participant in this trial.
- History of any autoimmune or current inflammatory conditions including rheumatoid arthritis or any other joint disease.
- History of malignancy, except for surgically cured basal cell carcinoma or cured cervical carcinoma (> 2 yrs prior to dosing).
- Currently has asthma or history of chronic obstructive pulmonary disease (COPD).
- Current evidence of ongoing or acute infection.
- The subject has a history of repeated, chronic or opportunistic infections which, in the opinion of the investigator and/or GSK Medical Monitor, places the subject at an unacceptable risk as a participant in this trial.
- History of Mycobacterium tuberculosis or any other previous Mycobacterium infection.
- A positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody testing result.
- History of a severe allergic reaction, angio-edema, anaphylaxis or immunodeficiency
- History of elevated blood pressure or blood pressure >140/90 millimeters of mercury (mmHg) at screening.
- Corrected QT interval (QTc) > 450 milliseconds.
- Where participation in study would result in donation of blood in excess of 500 mL within 56 days of starting the study.
- Subject whose calculated creatinine clearance is less than 80 mL/min
- Liver function tests above the upper limit of normal at screening (alkaline transaminase (ALT), aspartate transaminase (AST) or bilirubin).
- Chronic liver or biliary disease, history of Gilbert's syndrome in a previous clinical study or at screening.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Baltimore, Maryland, 21225
GSK Investigational Site
Evansville, Indiana, 47714
About this study
Official title: A Phase I, Randomized, Observer- and Subject-Blind, Placebo-Controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1827771 in Healthy Volunteers
GSK182771 is a domain antibody targeting the interleukin (IL)-1 receptor which is being developed for the treatment of rheumatoid arthritis. This study is being done in healthy volunteers to verify the safety and tolerability of GSK182771
- Conditions
- Arthritis, Rheumatoid
- Being tested
- GSK1827771, Placebo
- Keywords
- domain antibody, Rheumatoid Arthritis,
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1827771Drug
GSK1827771 will be administered using injection via subcutaneous (SC) route.
PlaceboDrug
Placebo to GSK1827771 for Injection will be administered via SC route
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving GSK 1827771 in sub-cohort Xa (Cohort 1-5) | Experimental | Eligible subjects will receive GSK1827771 with the starting dose of 0.3 milligram (mg) Receives: Drug: GSK1827771 |
| Subjects receiving placebo in sub-cohort Xa (Cohort 1-5) | Placebo comparator | Eligible subjects will receive placebo matching to GSK1827771 Receives: Drug: Placebo |
| Subjects receiving GSK 1827771 in sub-cohort Xb (Cohort 1-5) | Experimental | Eligible subjects will receive GSK1827771 via injection Receives: Drug: GSK1827771 |
| Subjects receiving placebo in sub-cohort Xb (Cohort 1-5) | Placebo comparator | Eligible subjects will receive placebo matching to GSK1827771 Receives: Drug: Placebo |
| Subjects receiving GSK 1827771 in sub-cohort Xc (Cohort 1-5) | Experimental | Eligible subjects will receive GSK1827771 via injection Receives: Drug: GSK1827771 |
| Subjects receiving placebo in sub-cohort Xc (Cohort 1-5) | Placebo comparator | Eligible subjects will receive placebo matching to GSK1827771 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with abnormal clinical chemistry findings
Blood samples will be collected at specific time points as a measure of safety
Measured: Up to 29 days
Number of subjects with abnormal clinical hematology findings
Blood samples will be collected at specific time points as a measure of safety
Measured: Up to 29 days
Number of subjects with abnormal urinalysis findings
Urine samples will be collected at specific time points as a measure of safety
Measured: Up to 29 days
Number of subjects with abnormal blood pressure values
Systolic and diastolic blood pressure will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
Measured: Up to 29 days
Number of subjects with abnormal heart rate values
Heart rate will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
Measured: Up to 29 days
Number of subjects with abnormal respiratory rate values
Respiratory rate will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
Measured: Up to 29 days
Number of subjects with abnormal body temperature findings
Body temperature will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
Measured: Up to 29 days
Number of subjects with abnormal electrocardiogram (ECG) findings
12-lead ECG measurements will be performed in a supine position after at least 5 minutes of rest as a measure of safety
Measured: Up to 29 days
Number of subjects with adverse events (AEs)
An adverse event 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 29 days
Secondary outcomes (11)
Plasma concentrations of GSK1827771
Blood samples will be collected at specific time points for calculating plasma concentrations of GSK1827771
Measured: Pre-dose, 0.25, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 1; in morning and evening on Day 2-7; in morning on Day 14, 21, 28
Maximum plasma concentration (Cmax) of GSK1827771
Blood samples will be collected at specific time points for calculating Cmax of GSK1827771
Measured: Pre-dose, 0.25, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 1; in morning and evening on Day 2-7; in morning on Day 14, 21, 28
Area under the curve (AUC) of GSK1827771
Blood samples will be collected at specific time points for calculating AUC of GSK1827771
Measured: Pre-dose, 0.25, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 1; in morning and evening on Day 2-7; in morning on Day 14, 21, 28
Frequency of anti-GSK1827771
The presence of anti-GSK1827771 binding antibodies will be assessed using an immunoelectrochemiluminescence screening assay (ECL).
Measured: Up to 29 days
Titer of anti-GSK1827771
Blood samples for determination of anti-GSK1827771 antibodies will be taken at specific time points.
Measured: Up to 29 days
Frequency of anti-PEG
Antibodies to PEG components of GSK1827771 will be measured.
Measured: Up to 29 days
Titer of anti-PEG
Antibodies to PEG components of GSK1827771 will be measured.
Measured: Up to 29 days
Frequency of anti-dAb
Antibodies to dAb components of GSK1827771 will be measured.
Measured: Up to 29 days
Titer of anti-dAb
Antibodies to dAb components of GSK1827771 will be measured.
Measured: Up to 29 days
Change from Baseline response of whole blood to ex vivo stimulation with IL-1 alpha or IL-1 beta
Blood samples will be collected for assessment of pharmacodynamic activity of GSK1827771 at specific time points
Measured: Baseline and up to 29 days
Exploratory biomarker levels in blood
Blood samples will be taken for exploratory biomarker analysis
Measured: Up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study start5 Sep 2007
- Primary completion5 Apr 2008
- Study completion5 Apr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- Single blind
- Who is masked
- Participant
- 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
- NCT00539760
- Sponsor's protocol ID
- 110394
- Status last verified
- Aug 2017
- First submitted
- 4 Oct 2007
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Observer- and Subject-Blind, Placebo-Controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1827771 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00539760
- Acronym / sponsor ID
- 110394
- Conditions
- Arthritis, Rheumatoid
- Keywords
- domain antibody, Rheumatoid Arthritis,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2007 (actual)
- Primary completion
- 5 Apr 2008 (actual)
- Study completion
- 5 Apr 2008 (actual)
- First posted
- 5 Oct 2007 (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.
GSK182771 is a domain antibody targeting the interleukin (IL)-1 receptor which is being developed for the treatment of rheumatoid arthritis. This study is being done in healthy volunteers to verify the safety and tolerability of GSK182771
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving GSK 1827771 in sub-cohort Xa (Cohort 1-5) | Experimental | Drug: GSK1827771Eligible subjects will receive GSK1827771 with the starting dose of 0.3 milligram (mg) |
| Subjects receiving placebo in sub-cohort Xa (Cohort 1-5) | Placebo comparator | Drug: PlaceboEligible subjects will receive placebo matching to GSK1827771 |
| Subjects receiving GSK 1827771 in sub-cohort Xb (Cohort 1-5) | Experimental | Drug: GSK1827771Eligible subjects will receive GSK1827771 via injection |
| Subjects receiving placebo in sub-cohort Xb (Cohort 1-5) | Placebo comparator | Drug: PlaceboEligible subjects will receive placebo matching to GSK1827771 |
| Subjects receiving GSK 1827771 in sub-cohort Xc (Cohort 1-5) | Experimental | Drug: GSK1827771Eligible subjects will receive GSK1827771 via injection |
| Subjects receiving placebo in sub-cohort Xc (Cohort 1-5) | Placebo comparator | Drug: PlaceboEligible subjects will receive placebo matching to GSK1827771 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult men or women as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests and cardiac assessment.
- Female subjects of non-childbearing potential.
- Male subjects must agree to abstain from or agree to use adequate contraception, in addition to having their female partner use another form of contraception. This criterion must be followed from the time of the first dose of study medication until Pharmacokinetic levels are determined to be below the LLQ.
- Men or women who are between 18 and 55 years of age, inclusive.
- Body Mass Index (BMI) within the range of 18-35 kilogram per meter square (kg/m^2) inclusive.
Key exclusion criteria (27 listed)
- The subject has a positive pre-study urine drug/urine alcohol screen. A minimum list of drugs that will be screened for includes amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A history of regular alcohol consumption averaging >7 drinks/week for females or >14 drinks/week for males. One drink is equivalent to (12 g alcohol) = 5 ounces [150 milliliter (mL)] of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits
- The subject is unwilling to abstain from alcohol consumption from 48 hour prior to dosing until discharge from the clinic, and for 48 hour prior to all other out-patient clinic visits.
- Smoked or used tobacco or nicotine-containing products within the previous 6 months prior to the first dose of current study medication.
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
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 |
|---|---|---|
| GSK1827771GSK1827771 will be administered using injection via subcutaneous (SC) route. | Drug | Subjects receiving GSK 1827771 in sub-cohort Xa (Cohort 1-5), Subjects receiving GSK 1827771 in sub-cohort Xb (Cohort 1-5), Subjects receiving GSK 1827771 in sub-cohort Xc (Cohort 1-5) |
| PlaceboPlacebo to GSK1827771 for Injection will be administered via SC route | Drug | Subjects receiving placebo in sub-cohort Xa (Cohort 1-5), Subjects receiving placebo in sub-cohort Xb (Cohort 1-5), Subjects receiving placebo in sub-cohort Xc (Cohort 1-5) |
Primary outcome
Number of subjects with abnormal clinical chemistry findings
Time frame: Up to 29 days
Blood samples will be collected at specific time points as a measure of safety
Number of subjects with abnormal clinical hematology findings
Time frame: Up to 29 days
Blood samples will be collected at specific time points as a measure of safety
Number of subjects with abnormal urinalysis findings
Time frame: Up to 29 days
Urine samples will be collected at specific time points as a measure of safety
Number of subjects with abnormal blood pressure values
Time frame: Up to 29 days
Systolic and diastolic blood pressure will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
Number of subjects with abnormal heart rate values
Time frame: Up to 29 days
Heart rate will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
Number of subjects with abnormal respiratory rate values
Time frame: Up to 29 days
Respiratory rate will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
Number of subjects with abnormal body temperature findings
Time frame: Up to 29 days
Body temperature will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
Number of subjects with abnormal electrocardiogram (ECG) findings
Time frame: Up to 29 days
12-lead ECG measurements will be performed in a supine position after at least 5 minutes of rest as a measure of safety
Number of subjects with adverse events (AEs)
Time frame: Up to 29 days
An adverse event 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.
11 secondary outcomes
Plasma concentrations of GSK1827771
Time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 1; in morning and evening on Day 2-7; in morning on Day 14, 21, 28
Maximum plasma concentration (Cmax) of GSK1827771
Time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 1; in morning and evening on Day 2-7; in morning on Day 14, 21, 28
Area under the curve (AUC) of GSK1827771
Time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 1; in morning and evening on Day 2-7; in morning on Day 14, 21, 28
Frequency of anti-GSK1827771
Time frame: Up to 29 days
Titer of anti-GSK1827771
Time frame: Up to 29 days
Frequency of anti-PEG
Time frame: Up to 29 days
Titer of anti-PEG
Time frame: Up to 29 days
Frequency of anti-dAb
Time frame: Up to 29 days
Titer of anti-dAb
Time frame: Up to 29 days
Change from Baseline response of whole blood to ex vivo stimulation with IL-1 alpha or IL-1 beta
Time frame: Baseline and up to 29 days
Exploratory biomarker levels in blood
Time frame: Up to 29 days
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 15 Aug 2017.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK1827771 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 2 sites in United States.
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 6 inclusion and 27 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 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 subjects with abnormal clinical chemistry findings (time frame: Up to 29 days). The study lists 9 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 15 Aug 2017.