A Safety and Pharmacokinetics Study of CNTO 3157 in Healthy Japanese and Caucasian Participants
29 septembre 2014 mis à jour par: Janssen Research & Development, LLC
A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of CNTO3157 Following an Escalating Single SC Dose to Healthy Japanese and Caucasian Subjects or a Single Intravenous Dose to Healthy Caucasian Subjects
The purpose of this study is to find out if different doses of CNTO 3157 are well tolerated in both Japanese and Caucasian men as well as to understand how the body absorbs and removes the study drug after being injected or infused into the body.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
This will be a randomized (the treatment is assigned by chance), double-blind (neither the participants nor study staff know the identity of the assigned treatment), placebo-controlled study (one of the study medications is inactive) to investigate the pharmacokinetics (ie, how the body absorbs and removes the study drug) and safety of subcutaneous (administered under the skin) (SC) CNTO 3157 (a drug currently being investigated for the treatment of asthma) in both Japanese and Caucasian men.
Additionally, an open-label cohort (where participants and study staff know the identity of the assigned treatment) in Caucasian men will investigate the pharmacokinetics and safety of a single intravenous (into a vein) (IV) infusion.
The study will consist of 3 phases: a screening phase, a treatment phase (comprising 2 days and 1 night at the study center) and a follow-up period (comprising approximately 11 visits to the study center).
During the double-blind SC treatment period, participants will be randomly assigned to 1 of 3 treatment groups: group 1 will receive a single SC injection of 100 mg CNTO 3157 or placebo; group 2 will receive 2 SC injections of CNTO 3157 (making a total dose of 300mg) or placebo; group 3 will receive 4 SC injections of CNTO 3157 (making a total dose of 600 mg) or placebo.
Group 4 (open-label cohort) will receive a single IV infusion of 300 mg CNTO 3157.
Participants will be enrolled in each SC dose group sequentially from the lower to higher dose level.
The study sponsor and the study doctor will review the test results (in terms of safety and tolerability) for each group before dosing participants in the next treatment group; this review will be carried out in a blinded manner.
An equal number of Japanese and Caucasian participants will be assigned to the SC treatment groups forming 2 subgroups within each group (groups 1A, 1B, 2A, 2B, 3A and 3B).
Within each SC treatment group, 10 participants will be randomly assigned in a 4 to 1 ratio to receive CNTO 3157 or placebo.
Only Caucasian participants will be enrolled in the IV treatment group (group 4).
For each treatment group, blood and urine samples will be taken at various time points during the study.
Each participant will take part in the study for approximately 85 days.
Participant safety will be monitored throughout the study.
Type d'étude
Interventionnel
Inscription (Réel)
40
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
California
-
Cypress, California, États-Unis
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 55 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Homme
La description
Inclusion Criteria:
- Participants must have a screening body weight in the range of 50 kg to 100 kg, inclusive, and a screening body mass index of 18.5 kg/m2 to 30 kg/m2, inclusive
- Participants must be: of Japanese descent whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report; Japanese participants must have valid government issued identification; Japanese participants must have resided outside of Japan for <= 5 years; or must be of non-Hispanic Caucasian descent whose parents are Caucasian, as determined by participant's verbal report
- Participants must have been exposed to herpes simplex-type 1 virus (HSV-1) as documented by a positive serology test result for HSV-1 performed at screening, but have no signs or symptoms suggestive of an active HSV-1 infection and are not receiving prescription treatment or prophylaxis for HSV-1
Exclusion Criteria:
- Participant has or has had a clinically significant (viral, bacterial or parasitic) infection, a prior history of recurrent serious infection (eg, sepsis, pneumonia or pyelonephritis) or be immunosuppressed or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening
- Participant is infected with human immunodeficiency virus or tests positive for hepatitis B virus infection or has antibodies to hepatitis C virus at screening
- Participant has received any live or attenuated virus or bacterial vaccinations within 3 months prior to study agent administration or is expected to receive any live virus or bacterial vaccinations during the study or up to 6 months after administration of the study agent
- Participant has had major surgery, (eg, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study OR has had a major illness or hospitalization within 1 month prior to study agent administration
- Participant has a history of, or currently active illness/disorder, considered to be clinically significant by the Investigator or any other illness/disorder that the Investigator considers should exclude the participant from the study or that could interfere with the interpretation of the study results
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Group 1A
100 mg CNTO 3157 or placebo in healthy male Japanese participants
|
A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
|
|
Expérimental: Group 1B
100 mg CNTO 3157 or placebo in healthy male Caucasian participants
|
A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
|
|
Expérimental: Group 2A
300 mg CNTO 3157 or placebo in healthy male Japanese participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
2 SC injections of CNTO 3157 providing a total dose of 300 mg
300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
|
|
Expérimental: Group 2B
300 mg CNTO 3157 or placebo in healthy male Caucasian participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
2 SC injections of CNTO 3157 providing a total dose of 300 mg
300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
|
|
Expérimental: Group 3A
600 mg CNTO 3157 or placebo in healthy male Japanese participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
4 SC injections of CNTO 3157 providing a total dose of 600 mg
|
|
Expérimental: Group 3B
600 mg CNTO 3157 or placebo in healthy male Caucasian participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
4 SC injections of CNTO 3157 providing a total dose of 600 mg
|
|
Expérimental: Group 4
300 mg CNTO 3157 in healthy male Caucasian participants
|
2 SC injections of CNTO 3157 providing a total dose of 300 mg
300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Frequency of adverse events
Délai: Up to Day 57
|
The frequency of adverse events will be used to assess the safety and tolerability of CNTO 3157.
|
Up to Day 57
|
|
Serum concentrations of CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg
Délai: Up to Day 57
|
Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug).
|
Up to Day 57
|
|
Titer (concentration) of antibodies to CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg
Délai: Up to Day 57
|
Serum samples will be screened for antibodies binding to CNTO 3157 providing an indication of the ability of CNTO 3157 to cause an immune response.
|
Up to Day 57
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Serum concentrations of CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg
Délai: Up to Day 57
|
Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug).
|
Up to Day 57
|
|
Titer (concentration) of antibodies to CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg
Délai: Up to Day 57
|
Serum samples will be screened for antibodies binding to CNTO 3157 providing an indication of the ability of CNTO 3157 to cause an immune response.
|
Up to Day 57
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2013
Achèvement primaire (Réel)
1 août 2014
Achèvement de l'étude (Réel)
1 août 2014
Dates d'inscription aux études
Première soumission
6 décembre 2013
Première soumission répondant aux critères de contrôle qualité
6 décembre 2013
Première publication (Estimation)
11 décembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
30 septembre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 septembre 2014
Dernière vérification
1 septembre 2014
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- CR102823
- CNTO3175NAP1001 (Autre identifiant: Janssen Research & Development, LLC)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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