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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877785
• Other study ID #: GV28916
• Status: Completed
• Phase: Phase 1
• First received: June 12, 2013
• Last updated: November 1, 2016
• Start date: July 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• MHAA4549A
Single-ascending dose of MHAA4549A
• Placebo
Placebo to MHAA4549A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		120 days	No
Secondary	Incidence of anti-therapeutic antibodies		120 days	No
Secondary	Pharmacokinetics: Serum concentration-time profile of MHAA4549A		Pre-dose on day 1 to day 120 post-dose	No