Healthy VolunteerPhase 1NCT01620931
A Single-Ascending-Dose Study of RO5469754 in Healthy Volunteers
A Phase 1 study testing RO5469754 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RO5469754
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Nov 2011to 3 Sep 2012
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Volunteer
- Being tested
- Placebo, RO5469754
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Single doses, iv or sc
RO5469754Drug
Single ascending doses, iv or sc
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| RO5469754 | Experimental | Not described Receives: Drug: RO5469754 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: approximately 1 year
Secondary outcomes (1)
Pharmacokinetics: Area under the concentration-time curve (AUC)
Measured: Pre-dose and up to 72/120 hours post-dose, and at follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study start7 Nov 2011
- Primary completion3 Sep 2012
- Study completion3 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620931
- Sponsor's protocol ID
- NP27885
- Status last verified
- Aug 2025
- First submitted
- 6 Jun 2012
- Last updated
- 28 Aug 2025
- Results posted
- No