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

NCT01620931 | Completed Phase 1

• 1 other identifier: NP27885
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of adverse events

  approximately 1 year

Secondary Outcomes (1)

• Pharmacokinetics: Area under the concentration-time curve (AUC)

  Pre-dose and up to 72/120 hours post-dose, and at follow-up

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

RO5469754

EXPERIMENTAL

Drug: RO5469754

Interventions

Placebo DRUG

Single doses, iv or sc

Placebo

RO5469754 DRUG

Single ascending doses, iv or sc

RO5469754

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Groningen, 9728 NZ, Netherlands

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 15, 2012
• Study Start: November 7, 2011
• Primary Completion: September 3, 2012
• Study Completion: September 3, 2012
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

NL (1)