- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00539760
A Phase I Rheumatoid Arthritis Study in Healthy Volunteers
perjantai 11. elokuuta 2017 päivittänyt: GlaxoSmithKline
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
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
45
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Indiana
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Evansville, Indiana, Yhdysvallat, 47714
- GSK Investigational Site
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Maryland
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Baltimore, Maryland, Yhdysvallat, 21225
- GSK Investigational Site
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 55 vuotta (Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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:
- 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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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)
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GSK1827771 will be administered using injection via subcutaneous (SC) route.
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Placebo Comparator: Subjects receiving placebo in sub-cohort Xa (Cohort 1-5)
Eligible subjects will receive placebo matching to GSK1827771
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Placebo to GSK1827771 for Injection will be administered via SC route
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Kokeellinen: Subjects receiving GSK 1827771 in sub-cohort Xb (Cohort 1-5)
Eligible subjects will receive GSK1827771 via injection
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GSK1827771 will be administered using injection via subcutaneous (SC) route.
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Placebo Comparator: Subjects receiving placebo in sub-cohort Xb (Cohort 1-5)
Eligible subjects will receive placebo matching to GSK1827771
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Placebo to GSK1827771 for Injection will be administered via SC route
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Kokeellinen: Subjects receiving GSK 1827771 in sub-cohort Xc (Cohort 1-5)
Eligible subjects will receive GSK1827771 via injection
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GSK1827771 will be administered using injection via subcutaneous (SC) route.
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Placebo Comparator: Subjects receiving placebo in sub-cohort Xc (Cohort 1-5)
Eligible subjects will receive placebo matching to GSK1827771
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Placebo to GSK1827771 for Injection will be administered via SC route
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Number of subjects with abnormal clinical chemistry findings
Aikaikkuna: Up to 29 days
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Blood samples will be collected at specific time points as a measure of safety
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Up to 29 days
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Number of subjects with abnormal clinical hematology findings
Aikaikkuna: Up to 29 days
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Blood samples will be collected at specific time points as a measure of safety
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Up to 29 days
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Number of subjects with abnormal urinalysis findings
Aikaikkuna: Up to 29 days
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Urine samples will be collected at specific time points as a measure of safety
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Up to 29 days
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Number of subjects with abnormal blood pressure values
Aikaikkuna: Up to 29 days
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Systolic and diastolic blood pressure will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
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Up to 29 days
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Number of subjects with abnormal heart rate values
Aikaikkuna: Up to 29 days
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Heart rate will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
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Up to 29 days
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Number of subjects with abnormal respiratory rate values
Aikaikkuna: Up to 29 days
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Respiratory rate will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
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Up to 29 days
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Number of subjects with abnormal body temperature findings
Aikaikkuna: Up to 29 days
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Body temperature will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
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Up to 29 days
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Number of subjects with abnormal electrocardiogram (ECG) findings
Aikaikkuna: Up to 29 days
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12-lead ECG measurements will be performed in a supine position after at least 5 minutes of rest as a measure of safety
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Up to 29 days
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Number of subjects with adverse events (AEs)
Aikaikkuna: Up to 29 days
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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.
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Up to 29 days
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Plasma concentrations of GSK1827771
Aikaikkuna: 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
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Blood samples will be collected at specific time points for calculating plasma concentrations of GSK1827771
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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
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Maximum plasma concentration (Cmax) of GSK1827771
Aikaikkuna: 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
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Blood samples will be collected at specific time points for calculating Cmax of GSK1827771
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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
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Area under the curve (AUC) of GSK1827771
Aikaikkuna: 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
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Blood samples will be collected at specific time points for calculating AUC of GSK1827771
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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
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Frequency of anti-GSK1827771
Aikaikkuna: Up to 29 days
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The presence of anti-GSK1827771 binding antibodies will be assessed using an immunoelectrochemiluminescence screening assay (ECL).
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Up to 29 days
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Titer of anti-GSK1827771
Aikaikkuna: Up to 29 days
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Blood samples for determination of anti-GSK1827771 antibodies will be taken at specific time points.
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Up to 29 days
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Frequency of anti-PEG
Aikaikkuna: Up to 29 days
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Antibodies to PEG components of GSK1827771 will be measured.
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Up to 29 days
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Titer of anti-PEG
Aikaikkuna: Up to 29 days
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Antibodies to PEG components of GSK1827771 will be measured.
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Up to 29 days
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Frequency of anti-dAb
Aikaikkuna: Up to 29 days
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Antibodies to dAb components of GSK1827771 will be measured.
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Up to 29 days
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Titer of anti-dAb
Aikaikkuna: Up to 29 days
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Antibodies to dAb components of GSK1827771 will be measured.
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Up to 29 days
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Change from Baseline response of whole blood to ex vivo stimulation with IL-1 alpha or IL-1 beta
Aikaikkuna: Baseline and up to 29 days
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Blood samples will be collected for assessment of pharmacodynamic activity of GSK1827771 at specific time points
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Baseline and up to 29 days
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Exploratory biomarker levels in blood
Aikaikkuna: Up to 29 days
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Blood samples will be taken for exploratory biomarker analysis
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Up to 29 days
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Keskiviikko 5. syyskuuta 2007
Ensisijainen valmistuminen (Todellinen)
Lauantai 5. huhtikuuta 2008
Opintojen valmistuminen (Todellinen)
Lauantai 5. huhtikuuta 2008
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 4. lokakuuta 2007
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 4. lokakuuta 2007
Ensimmäinen Lähetetty (Arvio)
Perjantai 5. lokakuuta 2007
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 15. elokuuta 2017
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 11. elokuuta 2017
Viimeksi vahvistettu
Tiistai 1. elokuuta 2017
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 110394
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