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A Pharmacodynamic Study to Evaluate Neutrophil Distribution Kinetics and Function Following Single-Dose RoActemra/Actemra (Tocilizumab) in Healthy Volunteers

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteer

Intervention: placebo (Drug); tocilizumab [RoActemra/Actemra] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This Phase IV, single-blind , randomized, two-arm study will explore the pharmacodynamics effects of RoActemra/Actemra (tocilizumab) on neutrophil redistribution, function and survival in healthy subjects. Subjects will receive either a single dose of intravenous (IV) RoActemra/Actemra at a dose of 8 mg/kg over one hour on study Day 0 or placebo. Neutrophil kinetics data will be collected for all subjects up to Day 10 of the study. Following the last study visit on Day 10, all subjects will attend two further safety follow-up visits on Day 28 and Day 56.

Clinical Details

Official title: A Single Blind Phase IV Pharmacodynamic Study to Evaluate Neutrophil Distribution Kinetics and Function Following Single-Dose Tocilizumab Treatment in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Primary outcome:

Neutrophil redistribution following 111Indium labelling

Neutrophil morphology

Neutrophil function

Neutrophil survival

Expression of neutrophil adhesion molecules

Secondary outcome: Safety: Incidence of adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Male aged between 18 and 65 years inclusive

- Healthy as determined by screening assessments

- Body mass index (BMI) 18 to 30 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 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 < 45 or >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

Locations and Contacts

Cambridge CB2 0QQ, United Kingdom
Additional Information

Starting date: May 2014
Last updated: July 1, 2015

Page last updated: August 20, 2015

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