Safety Study of ISIS 325568 in Healthy Volunteers
A Phase I, Double-Blind, Placebo-Controlled, Dose- Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 325568 Administered to Healthy Volunteers
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
-
Leiden, Niederlande
- Centre For Human Drug Research
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age 18 to 65 years
- Males or females. Females must be non-pregnant and non-lactating, and either surgically sterile (hysterectomy, oophorectomy, or tubal ligation) or post-menopausal. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, subject or partner must be using an acceptable contraceptive method during the trial and for 9 weeks after the last dose of study drug.
- Give written informed consent to participate in study and availability for all study requirements
- Fasting plasma glucose ≤ the upper limit of the laboratory's reference range (ULN)
- HbA1C ≤ ULN
- BMI < 30 kg/m2
Exclusion Criteria:
- Clinically significant abnormalities in medical history or physical examination
- Abnormalities on laboratory examination (ALT > ULN, AST > ULN, bilirubin > ULN, creatinine > ULN, urine protein positive by urine dipstick, platelets < lower limit of normal and any other clinically significant laboratory findings)
- History of clinically significant abnormalities in coagulation parameters
- Positive test result for HIV, hepatitis B virus, and/or hepatitis C virus
- Active infection requiring antiviral or antimicrobial therapy
- Subjects on chronic or acute prescription medication may be permitted after discussion with the Isis Medical Monitor.
- Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > 1 year)
- Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance
- History of alcohol or drug abuse
- Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to Screening.
- Blood donation within three months of screening
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: A
50 mg ISIS 325568 vs Placebo, s.c.
injection
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
|
Experimental: B
100 mg ISIS 325568 vs Placebo , s.c.
injection
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
|
Experimental: C
200 mg ISIS 325568 vs Placebo , s.c.
injection
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
|
Experimental: D
400 mg ISIS 325568 vs Placebo, s.c.
injection
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
|
Experimental: AA
50 mg ISIS 325568, 3x over 1 week i.v.
infusion, weekly s.c.
injection for 5 weeks vs Placebo
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
|
Experimental: BB
100 mg ISIS 325568, 3x over 1 week i.v.
infusion, weekly s.c.
injection for 5 weeks vs Placebo
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
|
Experimental: CC
200 mg ISIS 325568, 3x over 1 week i.v.
infusion, weekly s.c.
injection for 5 weeks vs Placebo
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
|
Experimental: DD
400 mg ISIS 325568, 3x over 1 week i.v.
infusion, weekly s.c.
injection for 5 weeks vs Placebo
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
safety and tolerability
Zeitfenster: 30 days for single dose, 16 weeks for multi-dose
|
30 days for single dose, 16 weeks for multi-dose
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Pharmacokinetic profile all doses and Pharmacodynamics for multi-dose groups.
Zeitfenster: 4 days for single dose, 16 weeks for multi-dose
|
4 days for single dose, 16 weeks for multi-dose
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: J. Burggraaf, MD PhD, Centre For Human Drug Research
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ISIS 325568-CS1
- EudraCT No: 2007-000235-25
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