A Study of Single Dose RO6811135 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01676584
First received: August 29, 2012
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This randomized, double-blind, placebo-controlled study will evaluate the safety

, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in healthy vo lunteers. Subjects will be randomized in cohorts to receive either single ascend ing doses of RO6811135 or placebo subcutaneously.


Condition Intervention Phase
Healthy Volunteer
Drug: RO6811135
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the concentration-time curve [ Time Frame: Pre-dose and up to 96 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacodynamics (blood analysis) of RO6811135 [ Time Frame: 96 hours ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: September 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: placebo
single doses sc
Experimental: RO6811135 Drug: RO6811135
single ascending doses sc

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676584

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01676584     History of Changes
Other Study ID Numbers: BP28410
Study First Received: August 29, 2012
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014