A Study of Single Dose RO6811135 in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676584
• Other study ID #: BP28410
• Status: Completed
• Phase: Phase 1
• First received: August 29, 2012
• Last updated: November 1, 2016
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO6811135
single ascending doses sc
• placebo
single doses sc

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		approximately 3 months	No
Secondary	Pharmacokinetics: Area under the concentration-time curve		Pre-dose and up to 96 hours post-dose	No
Secondary	Pharmacodynamics (blood analysis) of RO6811135		96 hours	No