CClinicalTrials.gg
CompletedNCT02281786Updated Nov 2, 2016

A Study of RO6926496 in Healthy Volunteers

A Phase 1 interventional study of Placebo and RO6926496 in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
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Study summary

This is a single center, randomized, investigator/subject blind, single ascending dose, placebo-controlled, parallel study that will evaluate the safety, tolerability and pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive in nature. It is planned to enroll 48 subjects in 6 cohorts. The anticipated total duration of the study is 16 weeks.

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Conditions studied

  • Healthy Volunteer
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In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male participants, 18 to 45 years of age; healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history
  • A body mass index between 18 and 30 kg/m2
  • Male subjects and their partners of childbearing potential must agree to use 2 methods of contraception, one of which must be a barrier method for the duration of the study

Exclusion criteria

Exclusion Criteria:

  • Positive hepatitis B, hepatitis C, or HIV infection
  • History of any clinically significant disease or disorder
  • Clinically significant abnormalities in laboratory test results
  • Participation in an investigational drug or device study within 90 days prior to screening
  • Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
  • History or presence of clinically significant ECG abnormalities
  • Smokers who smoke more than 10 cigarettes daily or equivalent and unable or unwilling not to smoke during the in-clinic period
  • Any clinically relevant history of hypersensitivity or allergic reactions
  • Any familial history of early onset Alzheimer's disease
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Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Cohort 1

    8 volunteers (6 active, 2 placebo)

    Drug: Placebo · Drug: RO6926496

  • Experimental
    Cohort 2

    8 volunteers (6 active, 2 placebo)

    Drug: Placebo · Drug: RO6926496

  • Experimental
    Cohort 3

    8 volunteers (6 active, 2 placebo)

    Drug: Placebo · Drug: RO6926496

  • Experimental
    Cohort 4

    8 volunteers (6 active, 2 placebo)

    Drug: Placebo · Drug: RO6926496

  • Experimental
    Cohort 5

    8 volunteers (6 active, 2 placebo)

    Drug: Placebo · Drug: RO6926496

  • Experimental
    Cohort 6

    8 volunteers (6 active, 2 placebo)

    Drug: Placebo · Drug: RO6926496

Interventions

  • DrugPlacebo

    Matching placebo to RO6926496

  • DrugRO6926496

    single, ascending dose, intravenous administration

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What researchers measure

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 16 weeks

Secondary outcomes

  1. Pharmacokinetic profile and parameters derived from serum concentrations of RO6926496 (composite outcome measure): area under the concentration-time curve (AUC), Cmax, tmax, clearance

    Time frame: Up to 16 weeks

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Study locations

1 site
  • Leeds, LS2 9LH, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02281786
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Nov 4, 2014
Start date
Jan 2015
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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