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OpenTrials
Completed

NCT Number: NCT01620931

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Single doses, iv or sc

RO5469754

Drug

Single ascending doses, iv or sc

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 15, 2012
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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