healthy volunteers (intended indication: Rheumatoid Arthritis) MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: TOCILI
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male aged between 18 and 65 years inclusive - Healthy as determined by screening assessments - Body Mass Index between 18 kg/m2 and 302 kg/m2 inclusive - Non-smoker - Must agree to use a barrier method of contraception supplemented with spermicide during the treatment period and for at least 150 days after the last dose of study drug Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Participation in a clinical study with an investigational drug within 3 months or at least 5 half-lives (whichever is longer) prior to dosing - Current or past history of smoking within 6 months - Previous exposure to therapeutic monoclonal antibodies in the past 6 months prior to screening - Current or clinically significant history of any condition that, in the opinion of the investigator, would: place the subject at undue risk; invalidate the giving of informed consent; interfere with PK or PD data; or interfere with the ability of the subject to complete the study - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies - Any recurrent infections; infection requiring antibiotic treatment in the 6 weeks prior to dosing; mononucleosis in the 6 months prior to dosing; known HIV, Hepatitis B, or Hepatitis C; or active infection at the time of screening - Active tuberculosis (TB) requiring treatment within the previous 3 years. - Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (except basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years - Primary or secondary immunodeficiency - Autoimmune disease - Use or dependence on substance of abuse - Alcohol abuse or average weekly intake greater than 2 units per day - Screening or baseline resting heart rate 90 beats per minute - Major surgery within 8 weeks prior to screening - Major illness in the 3 months prior to dosing - Biliary obstruction - Current or past history of diverticulitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PD objectives: To characterize the effects of TCZ on the following neutrophil tests in all healthy subjects. Relevant comparisons will be made between TCZ-treated and non-treated subjects and also any differences between TCZ-treated neutropenic (Grade 3/4) and non-neutropenic subjects: - Neutrophil redistribution following 111Indium labeling - Neutrophil morphology - Neutrophil function - Neutrophil survival - Expression of neutrophil adhesion molecules ;Secondary Objective: - To monitor safety and tolerability as part of addressing the PD objectives ;Primary end point(s): 1) Neutrophil redistribution following 111Indium labelling 2) Neutrophil morphology 3) Neutrophil function 4) Neutrophil survival 5) Expression of neutrophil adhesion molecules;Timepoint(s) of evaluation of this end point: 1) 10 days 2-5) 4 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety: Incidence of adverse events;Timepoint(s) of evaluation of this end point: 56 days | — |
Countries
United Kingdom
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed