CompletedNCT00539760Updated Aug 15, 2017

A Phase I Rheumatoid Arthritis Study in Healthy Volunteers

A Phase 1 interventional study of GSK1827771 and Placebo in Arthritis, Rheumatoid, sponsored by GlaxoSmithKline. Completed at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-15.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 45
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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

Conditions studied

Arthritis, Rheumatoid

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Keywords

domain antibody
Rheumatoid Arthritis,

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 45 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,561 studies on the registry; 116 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 45 participants (actual)

Study arms

Experimental
Subjects receiving GSK 1827771 in sub-cohort Xa (Cohort 1-5)
Eligible subjects will receive GSK1827771 with the starting dose of 0.3 milligram (mg)
Drug: GSK1827771
Placebo comparator
Subjects receiving placebo in sub-cohort Xa (Cohort 1-5)
Eligible subjects will receive placebo matching to GSK1827771
Drug: Placebo
Experimental
Subjects receiving GSK 1827771 in sub-cohort Xb (Cohort 1-5)
Eligible subjects will receive GSK1827771 via injection
Drug: GSK1827771
Placebo comparator
Subjects receiving placebo in sub-cohort Xb (Cohort 1-5)
Eligible subjects will receive placebo matching to GSK1827771
Drug: Placebo
Experimental
Subjects receiving GSK 1827771 in sub-cohort Xc (Cohort 1-5)
Eligible subjects will receive GSK1827771 via injection
Drug: GSK1827771
Placebo comparator
Subjects receiving placebo in sub-cohort Xc (Cohort 1-5)
Eligible subjects will receive placebo matching to GSK1827771
Drug: Placebo

Interventions

DrugGSK1827771
GSK1827771 will be administered using injection via subcutaneous (SC) route.
DrugPlacebo
Placebo to GSK1827771 for Injection will be administered via SC route

What researchers measure

Primary outcomes

Number of subjects with abnormal clinical chemistry findings
Blood samples will be collected at specific time points as a measure of safety
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Up to 29 days

Secondary outcomes

Plasma concentrations of GSK1827771
Blood samples will be collected at specific time points for calculating 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
Blood samples will be collected at specific time points for calculating 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
Blood samples will be collected at specific time points for calculating 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
The presence of anti-GSK1827771 binding antibodies will be assessed using an immunoelectrochemiluminescence screening assay (ECL).
Time frame: Up to 29 days
Titer of anti-GSK1827771
Blood samples for determination of anti-GSK1827771 antibodies will be taken at specific time points.
Time frame: Up to 29 days
Frequency of anti-PEG
Antibodies to PEG components of GSK1827771 will be measured.
Time frame: Up to 29 days
Titer of anti-PEG
Antibodies to PEG components of GSK1827771 will be measured.
Time frame: Up to 29 days
Frequency of anti-dAb
Antibodies to dAb components of GSK1827771 will be measured.
Time frame: Up to 29 days
Titer of anti-dAb
Antibodies to dAb components of GSK1827771 will be measured.
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
Blood samples will be collected for assessment of pharmacodynamic activity of GSK1827771 at specific time points
Time frame: Baseline and up to 29 days
Exploratory biomarker levels in blood
Blood samples will be taken for exploratory biomarker analysis
Time frame: Up to 29 days

Study locations

2 sites

GSK Investigational Site
Evansville, Indiana 47714, United States
GSK Investigational Site
Baltimore, Maryland 21225, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00539760
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Oct 5, 2007
Start date: Sep 5, 2007
Primary completion: Apr 5, 2008
Completion: Apr 5, 2008
Last update: Aug 15, 2017

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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