A Study of Single Dose RO6811135 in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01676584

Enrollment

Registered

2012-08-31

Start date

2012-09-30

Completion date

2012-12-31

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 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.

Interventions

DRUGRO6811135

single ascending doses sc

DRUGplacebo

single doses sc

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	approximately 3 months

Secondary

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

Countries

United States

Outcome results

None listed

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