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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: MHAA4549A; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1P 0A2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Arm	Drug: Placebo; Placebo to MHAA4549A
Experimental: MHAA4549A Arm	Drug: MHAA4549A; Single-ascending dose of MHAA4549A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events	120 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of anti-therapeutic antibodies	120 days
Pharmacokinetics: Serum concentration-time profile of MHAA4549A	Pre-dose on day 1 to day 120 post-dose

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Publications and helpful links

General Publications

• Lim JJ, Deng R, Derby MA, Larouche R, Horn P, Anderson M, Maia M, Carrier S, Pelletier I, Burgess T, Kulkarni P, Newton E, Tavel JA. Two Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Studies To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza A Virus Monoclonal Antibody, MHAA4549A, in Healthy Volunteers. Antimicrob Agents Chemother. 2016 Aug 22;60(9):5437-44. doi: 10.1128/AAC.00607-16. Print 2016 Sep.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: June 12, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (Estimate): June 14, 2013

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: GV28916