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

NCT01877785 | Completed Phase 1

• 1 other identifier: GV28916
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of adverse events

  120 days

Secondary Outcomes (2)

• Incidence of anti-therapeutic antibodies

  120 days

• Pharmacokinetics: Serum concentration-time profile of MHAA4549A

  Pre-dose on day 1 to day 120 post-dose

Study Arms (2)

MHAA4549A Arm

EXPERIMENTAL

Drug: MHAA4549A

Placebo Arm

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MHAA4549A DRUG

Single-ascending dose of MHAA4549A

MHAA4549A Arm

Placebo DRUG

Placebo to MHAA4549A

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Unknown Facility

Québec, Quebec, G1P 0A2, Canada

Location

Related Publications (1)

• 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.

  PMID: 27381392 DERIVED

MeSH Terms

Interventions

gedivumab

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 14, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

CA (1)