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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620931
• Other study ID #: NP27885
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2012
• Last updated: February 4, 2013
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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. In-clinic period will be from Day -1 to Day 4, with a safety follow-up of 15 weeks after dosing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO5469754
Single ascending doses, iv or sc
• Placebo
Single doses, iv or sc

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		approximately 1 year	No
Secondary	Pharmacokinetics: Area under the concentration-time curve (AUC)		Pre-dose and up to 72/120 hours post-dose, and at follow-up	No