A Study of Single Dose RO6811135 in Healthy Volunteers

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: placebo; Drug: RO6811135

Study type: Interventional

Funder types: Industry

Identifiers

NCT01676584

BP28410

Details and patient eligibility

About

This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in healthy volunteers. Subjects will be randomized in cohorts to receive either single ascending doses of RO6811135 or placebo subcutaneously.

Enrollment: 56 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female volunteers, 18 to 45 years of age inclusive
• Body mass index (BMI) 22-32 kg/m2 inclusive
• Females of child-bearing potential and males with female partners of child-bearing potential must agree to use adequate contraception as defined by protocol

Exclusion criteria

• History or presence of any clinically relevant disease or disorder
• History of drug hypersensitivity or food allergies
• Significant infection or known inflammatory process at screening or Day -1
• Any history of alcohol and/or drug of abuse addiction
• Alcohol consumption of more than 14 units (1 unit = 10 mL of pure alcohol) per week
• Smoking more than 5 cigarettes a day or equivalent amount of tobacco
• Positive for hepatitis B, hepatitis C or HIV infection
• Participation in an investigational drug or device study within 3 months prior to screening

Trial design

56 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

RO6811135

Experimental group

Treatment:

Drug: RO6811135