A Study of MHAA4549A to Assess Safety And Pharmacokinetic... | NCT01877785

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

NCT01877785

Sponsor

Genentech, Inc.

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

21Actual

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

MHAA4549A
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Jun 12, 2013

First Submission Date that Met QC Criteria

Jun 12, 2013

First Posted Date

Jun 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MHAA4549A Arm	Experimental		Drug: MHAA4549A
Placebo Arm	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MHAA4549A	Drug	Single-ascending dose of MHAA4549A	MHAA4549A Arm
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trials	Genentech, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Québec	Quebec	G1P 0A2	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27381392	Derived	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.