A Study of Single Dose RO6811135 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01676584
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO6811135 Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6811135 in Healthy Subjects.
Study Start Date : September 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: placebo
single doses sc
Experimental: RO6811135 Drug: RO6811135
single ascending doses sc

Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: approximately 3 months ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Area under the concentration-time curve [ Time Frame: Pre-dose and up to 96 hours post-dose ]
  2. Pharmacodynamics (blood analysis) of RO6811135 [ Time Frame: 96 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01676584

United States, Ohio
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01676584     History of Changes
Other Study ID Numbers: BP28410
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016