- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT02388347
A Study to Assess the Safety of MEDI7836 in Healthy Adults.
2017. április 13. frissítette: MedImmune LLC
A Phase 1a, Randomised, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI7836 in Healthy Adults
To assess the safety of a single ascending dose of MEDI7836 in healthy adult male subjects and healthy adult female subjects of non-childbearing potential.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Részletes leírás
This is a Phase 1a, randomised, blinded (the investigator and subject will be blinded to treatment assignment and sponsor will be unblinded to treatment assignment), placebo-controlled study to evaluate the safety of single-ascending SC doses of MEDI7836 in healthy adult males subjects and healthy adult female subjects of non-childbearing potential.
The study will be conducted at a single site in the United Kingdom (UK).
Four dosing cohorts of MEDI7836 or placebo are planned for this study for a total of 32 subjects (24 subjects receiving MEDI7836, 8 subjects receiving placebo).
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
79
Fázis
- 1. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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London, Egyesült Királyság
- Research Site
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év (Felnőtt)
Egészséges önkénteseket fogad
Igen
Tanulmányozható nemek
Összes
Leírás
Inclusion Criteria:
- Vital signs, ECG, and laboratory parameters within normal range at screening and Day -1
- Negative alcohol and drug screen at screening and Day -1
- Able and willing to comply with the requirements of the protocol
- Females subjects must have been surgically sterilised or be postmenopausal
- Nonsterilised males who are sexually active with a female partner of childbearing potential or a female partner who has been surgically sterilised by bilateral tubal ligation must use a condom with spermicide with their partner from screening until the end of the study follow-up period
Exclusion Criteria:
- Concurrent enrolment in another clinical study where the subject is receiving an investigational product
- Individuals who are legally institutionalised
- Receipt of any marketed or investigational biologic agent within 4 months
- Receipt of any investigational non-biologic agent within 3 months or 5 half-lives prior to screening, whichever is longer
- Use of any medication (prescription or over the counter, including herbal remedies) within 14 days or 5 half-lives of Day 1,
- Known history of allergy or reaction to any component of the investigational product formulation
- History of anaphylaxis following any biologic therapy
- History of chronic alcohol or drug abuse within 12 months prior to screening,
- Presence of a positive drug or alcohol screen at screening and Day -1.
- Current smoker, or history of smoking within 6 months of screening
- Pregnant or breastfeeding women
- Any active medical or psychiatric condition or other reason which, in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject's ability to participate in the study
- Any clinically relevant abnormal findings in physical examination, ECG, vital signs, haematology, clinical chemistry or urinalysis during screening or Day -1,
- History of any known primary immunodeficiency disorder or use of immunosuppressive medication within 12 months of screening
- History of a clinically significant infection requiring antibiotics or antiviral medication from 30 days prior to screening, up to and including Day 1
- Diagnosis of a helminth parasitic infection within 6 months prior to screening that has not been treated with, or has failed to respond to, standard of care therapy
- History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 12 months prior to screening or other malignancies treated with apparent success with curative therapy ≥ 5 years prior to screening
- Positive tuberculosis (TB) test (Quantiferon-TB Gold) at screening or TB requiring treatment within the 12 months prior to the screening visit
- Positive hepatitis B surface antigen, hepatitis B anti-core antibody, or hepatitis C virus antibody serology at screening.
- Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enter the study.
- A positive human immunodeficiency virus test at screening or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report
- Evidence of active liver disease, including jaundice or aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase greater than twice the upper limit of normal (ULN)
- Major surgery within 8 weeks prior to screening, or planed in-patient surgery or hospitalisation during the study period
- Receipt of live attenuated vaccines 30 days prior to the date of screening Where participation in the study would result in donation of blood or blood products in excess of 500 mL within an 8-week period
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Placebo Comparator: Placebo
Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1.
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Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1.
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Kísérleti: MEDI7836 Dose 1
Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1.
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Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1.
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Kísérleti: MEDI7836 Dose 2
Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1.
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Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1.
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Kísérleti: MEDI7836 Dose 3
Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1.
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Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1.
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Kísérleti: MEDI7836 Dose 4
Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.
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Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Időkeret: From Study Drug Administration to 281 Days Postdose
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Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received MEDI7836.
Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pretreatment state.
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From Study Drug Administration to 281 Days Postdose
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Number of Participants With Injection Site Reactions
Időkeret: From Study Drug Administration to 281 Days Postdose
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Participants were evaluated for manifestations of injection site reactions.
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From Study Drug Administration to 281 Days Postdose
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Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
Időkeret: From Study Drug Administration to 281 Days Postdose
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An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event.
Treatment-emergent adverse events between first dose of study drug and Day 281 after the last dose that were absent before treatment or that worsened relative to pre-treatment state.
Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
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From Study Drug Administration to 281 Days Postdose
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Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment-Emergent Adverse Events
Időkeret: From Study Drug Administration to 281 Days Postdose
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Vital sign parameters included blood pressure, temperature, pulse rate, respiratory rate and weight.
Physical examination included assessment of general appearance, weight, head, ears, eyes, nose, throat, neck, skin, cardiovascular system, respiratory system, abdominal system, and nervous system.
Criteria for abnormal physical findings was based on investigator's discretion.
TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Day 281 after the last dose of study drug.
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From Study Drug Administration to 281 Days Postdose
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Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events
Időkeret: From Study Drug Administration to 281 Days Postdose
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AEs observed in participants with clinically significant ECG abnormalities were assessed.
ECG parameters included heart rate, RR, PR, QRS, QT and QTc intervals.
Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pre-treatment state.
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From Study Drug Administration to 281 Days Postdose
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI7836
Időkeret: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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Area under the concentration-time curve of the MEDI7836 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf).
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Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t]) of MEDI7836
Időkeret: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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Area under the concentration-time curve of the MEDI7836 in serum over the time interval from 0 to the last quantifiable data point (AUC0-t).
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Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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Maximum Observed Serum Concentration (Cmax) of MEDI7836
Időkeret: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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The Cmax is the maximum observed serum concentration of study drug.
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Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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Apparent Systemic Clearance (CL/F) of MEDI7836
Időkeret: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
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Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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Terminal Phase Elimination Half Life (T1/2) of MEDI7836
Időkeret: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.
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Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI7836
Időkeret: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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The Tmax is defined as actual sampling time to reach maximum observed MEDI7836 concentration.
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Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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Apparent Terminal-Phase Volume of Distribution (Vz/F) of MEDI7836
Időkeret: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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The apparent volume of distribution of MEDI7836 after a single dose, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz).
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Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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Percentage of Participants Positive for Anti-Drug Antibodies to MEDI7836
Időkeret: Predose on Day 1 to 281 days Postdose
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A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.
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Predose on Day 1 to 281 days Postdose
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Kutatásvezető: Annelize Koch, MD, Parexel
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2015. március 1.
Elsődleges befejezés (Tényleges)
2016. január 1.
A tanulmány befejezése (Tényleges)
2016. április 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2015. március 9.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2015. március 13.
Első közzététel (Becslés)
2015. március 17.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2017. május 16.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2017. április 13.
Utolsó ellenőrzés
2017. április 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- D5450C00001
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
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