Healthy Volunteer
Conditions
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.
Interventions
DRUGPlacebo
Single doses, iv or sc
DRUGRO5469754
Single ascending doses, iv or sc
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events | approximately 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Area under the concentration-time curve (AUC) | Pre-dose and up to 72/120 hours post-dose, and at follow-up |
Countries
Netherlands
Outcome results
None listed