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OpenTrials
Completed

NCT Number: NCT01676584

A Study of Single Dose RO6811135 in Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cincinnati, Ohio, 45227, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO6811135

Drug

single ascending doses sc

Placebo

Drug

single doses sc

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 3 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6811135 in Healthy Subjects.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 31, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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