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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01620931
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : February 5, 2013
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO5469754 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
Experimental: RO5469754 Drug: RO5469754
Single ascending doses, iv or sc

Placebo Comparator: Placebo Drug: Placebo
Single doses, iv or sc

Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: approximately 1 year ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 72/120 hours post-dose, and at follow-up ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01620931

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

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Responsible Party: Hoffmann-La Roche Identifier: NCT01620931    
Other Study ID Numbers: NP27885
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013