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

Roche

Status and phase: Completed; Phase 4

Conditions: Healthy Volunteer

Treatments: Drug: placebo; Drug: tocilizumab [RoActemra/Actemra]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01991990

WA29049

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

18 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

RoActemra/Actemra

Experimental group

Treatment:

Drug: tocilizumab [RoActemra/Actemra]