A Single-Ascending-Dose Study of RO5469754 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01620931
First received: June 6, 2012
Last updated: February 4, 2013
Last verified: February 2013

June 6, 2012
February 4, 2013
November 2011
November 2012   (final data collection date for primary outcome measure)
Safety: Incidence of adverse events [ Time Frame: approximately 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01620931 on ClinicalTrials.gov Archive Site
Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 72/120 hours post-dose, and at follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Single-Ascending-Dose Study of RO5469754 in Healthy Volunteers
A Single-Center, Randomized, Observer-Blinded, Placebo-Controlled, Single-Ascending-Dose (SAD) Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5469754, a Humanized Monoclonal Antibody, Following Intravenous or Subcutaneous Administration in Healthy Adults

This randomized, observer-blinded, placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5469754 in healthy volunteers. Subjects will be randomized in cohorts to receive single ascending intravenous or subcutaneous doses of RO5469754 or placebo. In-clinic period will be from Day -1 to Day 4, with a safety follow-up of 15 weeks after dosing.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Healthy Volunteer
  • Drug: RO5469754
    Single ascending doses, iv or sc
  • Drug: Placebo
    Single doses, iv or sc
  • Experimental: RO5469754
    Intervention: Drug: RO5469754
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or female volunteers, 18 to 64 years of age, inclusive
  • Body mass index (BMI) 18 to 32 kg/m2
  • Women of child-bearing potential and their partners must be willing to use two highly effective forms of contraception, one of which must be a barrier method, for the entire duration of the study (through study discharge) or for up to five half-lives after the last dose
  • Male subjects with female partners of child-bearing potential must be willing to use a condom during sexual activity for the duration of the study (through study discharge) or for up to five half-lives after the last dose

Exclusion Criteria:

  • Pregnant or lactating women
  • Positive test for drugs of abuse (including ethanol) as per local standards
  • Willing to comply with a non-smoking policy during the in-clinic part of the study (Day -1 until discharge on Day 4)
  • Positive for hepatitis B, hepatitis C or HIV infection
  • History or presence of clinically significant disease or condition
  • Participation in an investigational drug or device study within 60 days prior to dosing
  • Current (or previous history of) exposure to therapeutic or investigational monoclonal antibody or chimeric biomolecule
  • Any confirmed clinically significant previous allergic drug reaction, or history of anaphylaxis
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01620931
NP27885
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP