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Clinical Trials/NCT01676584
NCT01676584CompletedPhase 1

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

Hoffmann-La Roche0 sites56 target enrollmentStarted: September 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
56
Primary Endpoint
Safety: Incidence of adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
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

Arms & Interventions

Placebo

Placebo Comparator

Intervention: placebo (Drug)

RO6811135

Experimental

Intervention: RO6811135 (Drug)

Outcomes

Primary Outcomes

Safety: Incidence of adverse events

Time Frame: approximately 3 months

Secondary Outcomes

  • Pharmacokinetics: Area under the concentration-time curve(Pre-dose and up to 96 hours post-dose)
  • Pharmacodynamics (blood analysis) of RO6811135(96 hours)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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