A Study of RO6926496 in Healthy Volunteers

NCT02281786 | Completed Phase 1

• 2 other identifiers: BP294622014-003170-16
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)

  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

  Up to 16 weeks

Study Arms (6)

Cohort 1

EXPERIMENTAL

8 volunteers (6 active, 2 placebo)

Drug: Placebo; Drug: RO6926496

Cohort 2

EXPERIMENTAL

8 volunteers (6 active, 2 placebo)

Drug: Placebo; Drug: RO6926496

Cohort 3

EXPERIMENTAL

8 volunteers (6 active, 2 placebo)

Drug: Placebo; Drug: RO6926496

Cohort 4

EXPERIMENTAL

8 volunteers (6 active, 2 placebo)

Drug: Placebo; Drug: RO6926496

Cohort 5

EXPERIMENTAL

8 volunteers (6 active, 2 placebo)

Drug: Placebo; Drug: RO6926496

Cohort 6

EXPERIMENTAL

8 volunteers (6 active, 2 placebo)

Drug: Placebo; Drug: RO6926496

Interventions

Placebo DRUG

Matching placebo to RO6926496

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

RO6926496 DRUG

single, ascending dose, intravenous administration

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Leeds, LS2 9LH, United Kingdom

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: October 30, 2014
• First Posted: November 4, 2014
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

GB (1)