NCT01676584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

August 29, 2012

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Safety: Incidence of adverse events

    approximately 3 months

Secondary Outcomes (2)

  • Pharmacokinetics: Area under the concentration-time curve

    Pre-dose and up to 96 hours post-dose

  • Pharmacodynamics (blood analysis) of RO6811135

    96 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: placebo

RO6811135

EXPERIMENTAL
Drug: RO6811135

Interventions

RO6811135DRUG

single ascending doses sc

RO6811135
placeboDRUG

single doses sc

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Cincinnati, Ohio, 45227, United States

Location

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

August 31, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(1)