- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01583530
Study of Belimumab Administered Subcutaneously to Healthy Subjects
1. August 2013 aktualisiert von: Human Genome Sciences Inc.
A Randomized, Parallel-Group, Open-Label Study to Evaluate the Absolute Bioavailability, Pharmacokinetics, Tolerability and Safety of a High Concentration Formulation of Belimumab (HGS1006), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Healthy Subjects
The purpose of this study is to measure the amount of belimumab in the blood when given as an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of multiple injections under the skin in healthy subjects.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
- Biologisch: Single Dose Group: Belimumab IV 240 mg
- Biologisch: Single Dose Group: Belimumab SC 2 x 120 mg
- Biologisch: Single Dose Group: Belimumab SC 1 x 240 mg
- Biologisch: Single Dose Group: Belimumab SC 1 x 200 mg
- Biologisch: Multiple Dose Group: Belimumab SC 2 x 120 mg weekly
- Biologisch: Multiple Dose Group: Belimumab SC 1 x 200 mg weekly
Detaillierte Beschreibung
This study is designed to evaluate the absolute bioavailability, pharmacokinetics, tolerability, and safety of a single dose (groups 1-4) or multiple doses (groups 5-6) of belimumab administered subcutaneously (SC) to healthy subjects.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
118
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Florida
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Daytona Beach, Florida, Vereinigte Staaten
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Indiana
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Evansville, Indiana, Vereinigte Staaten
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Texas
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Dallas, Texas, Vereinigte Staaten
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Wisconsin
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Madison, Wisconsin, Vereinigte Staaten
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 55 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Key Inclusion Criteria:
- Healthy subjects defined as no clinically relevant abnormalities identified by a detailed medical history, full physical exam, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- Body weight between 45 to 120 kg (99 to 264 lbs).
- Must agree to use effective contraception throughout the study and for 14 weeks after administration of belimumab.
- Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures.
Key Exclusion Criteria:
- Pregnant or nursing.
- Test positive for drugs or alcohol or have had a drug or alcohol dependence within the past year.
- Have used any prescription medicines within the past 30 days or herbal/botanical supplements within the past 7 days or anticipate use during the study. May use prescription contraceptives, hormone replacement therapy, and over-the-counter medicines such as antihistamines or nutritional support such as vitamins, minerals, or amino acids.
- Have received a live vaccine within the past 30 days or anticipate receipt of a live vaccine during the study and within 4 months after last injection of belimumab.
- Have a history of an allergic or anaphylactic reaction to drugs, food, or insect bite or sting requiring medical intervention.
- Have a history of allergic reaction to contrast agents or biological medicines.
- Have participated in a clinical trial and received an experimental medicine within the past 60 days.
- Have received treatment with a B cell targeted therapy at any time.
- Have required management of an infection within the past 14 days.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: Belimumab IV 240 mg
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Belimumab IV 240 mg administered on Day 0
Andere Namen:
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Experimental: Belimumab SC 2 x 120 mg
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Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
Andere Namen:
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Experimental: Belimumab SC 1 x 240 mg
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Belimumab SC 240 mg x 1 injection on Day 0
Andere Namen:
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Experimental: Belimumab SC 1 x 200 mg
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Belimumab SC 200 mg x 1 injection on Day 0
Andere Namen:
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Experimental: Belimumab SC 2 x 120 mg weekly
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Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
Andere Namen:
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Experimental: Belimumab SC 1 x 200 mg weekly
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Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC)
Zeitfenster: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
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Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
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Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC
Zeitfenster: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
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Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
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Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC
Zeitfenster: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
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AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞).
It is obtained from AUC (0-last) plus C (last)/λz.
C (last) is the last measurable concentration.
λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.
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Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
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Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC
Zeitfenster: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
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Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.
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Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
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Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC
Zeitfenster: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
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Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation.
The bioavailability of belimumab administered by IV is compared to the bioavailability of belimumab administered via single-SC injection.
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Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab
Zeitfenster: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
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Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
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Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab
Zeitfenster: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
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Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
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Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab
Zeitfenster: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
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AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞).
It is obtained from AUC (0-last) plus C (last)/λz.
C (last) is the last measurable concentration.
λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.
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Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
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Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab
Zeitfenster: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
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Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.
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Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
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Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab
Zeitfenster: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
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Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation.
The bioavailability following weekly (x 4) SC injections of belimumab was calculated by comparing the bioavailability of belimumab administered IV to the bioavailability of belimumab administered via 4 weekly SC injections.
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Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
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Number of Participants Who Experienced Adverse Events
Zeitfenster: Up to Day 119
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Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
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Up to Day 119
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.
- Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Februar 2011
Primärer Abschluss (Tatsächlich)
1. September 2011
Studienabschluss (Tatsächlich)
1. September 2011
Studienanmeldedaten
Zuerst eingereicht
20. April 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
23. April 2012
Zuerst gepostet (Schätzen)
24. April 2012
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
7. August 2013
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
1. August 2013
Zuletzt verifiziert
1. August 2013
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HGS1006-C1105
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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