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

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ClinicalTrials.gov Identifier: NCT01877785
Recruitment Status : Completed
First Posted : June 14, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: MHAA4549A Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official 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
Study Start Date : July 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: MHAA4549A Arm Drug: MHAA4549A
Single-ascending dose of MHAA4549A

Placebo Comparator: Placebo Arm Drug: Placebo
Placebo to MHAA4549A

Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: 120 days ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877785

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Quebec, Canada, G1P 0A2
Sponsors and Collaborators
Genentech, Inc.
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Study Director: Clinical Trials Genentech, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01877785    
Other Study ID Numbers: GV28916
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016