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
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: RO5469754
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RO5469754 Drug: RO5469754
Single ascending doses, iv or sc
Placebo Comparator: Placebo Drug: Placebo
Single doses, iv or sc

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620931

Locations
Netherlands
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01620931     History of Changes
Other Study ID Numbers: NP27885
Study First Received: June 6, 2012
Last Updated: February 4, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on July 22, 2014