A Study of RO6926496 in Healthy Volunteers

A SINGLE-CENTER, RANDOMIZED, INVESTIGATOR/SUBJECT BLIND, SINGLE ASCENDING DOSE, PLACEBO CONTROLLED, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF RO6926496 FOLLOWING INTRAVENOUS INFUSION IN HEALTHY SUBJECTS

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02281786

Enrollment

Registered

2014-11-04

Start date

2015-01-31

Completion date

2015-10-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief 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.

Interventions

DRUGPlacebo

Matching placebo to RO6926496

DRUGRO6926496

single, ascending dose, intravenous administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

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

* 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

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events (AEs)	Up to 16 weeks

Secondary

Measure	Time frame
Pharmacokinetic profile and parameters derived from serum concentrations of RO6926496 (composite outcome measure): area under the concentration-time curve (AUC), Cmax, tmax, clearance	Up to 16 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026