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Completed

NCT Number: NCT01877785

A Study of MHAA4549A to Assess Safety And Pharmacokinetics in Healthy Volunteers

This randomized, double-blind, placebo-controlled, single-ascending dose study will assess the safety, tolerability and pharmacokinetics of ascending doses of MHAA4549A in healthy volunteers. Volunteers will be randomized to receive a single dose of MHAA4549A or matching placebo.

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Key information

Conditions

Healthy Volunteer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Québec, Quebec, G1P 0A2, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers
  • Body mass index (BMI) between 18 and 32 kg/m2, inclusive
  • Weight 40 to 100 kg
  • In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
  • Clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor
  • Volunteers agree to use acceptable contraceptive measures

Exclusion criteria

  • History or clinically significant manifestations of disorders
  • History of anaphylaxis, hypersensitivity or drug allergies
  • History or presence of an abnormal ECG
  • History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit
  • History of significant drug abuse within 1 year prior to screening
  • Current tobacco smokers
  • Positive drug screen at screening or at check-in
  • Positive pregnancy test result at screening or Day -1 or breast feeding during the study

Treatment and study plan

MHAA4549A

Drug

Single-ascending dose of MHAA4549A

Placebo

Drug

Placebo to MHAA4549A

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 120 days

Secondary outcomes

  1. Incidence of anti-therapeutic antibodies

    Time frame: 120 days

  2. Pharmacokinetics: Serum concentration-time profile of MHAA4549A

    Time frame: Pre-dose on day 1 to day 120 post-dose

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAA4549A in Healthy Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 14, 2013
Registry last updated
Nov 2, 2016

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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