A Study of High Dose MHAA4549A in Healthy Volunteers

Genentech

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: Placebo

Drug: MHAA4549A

Study type

Interventional

Funder types

Industry

Identifiers

NCT02284607

GV29609

Details and patient eligibility

About

This Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of two, single intravenous (IV) high doses of MHAA4549A as compared to placebo when administered to healthy volunteers.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 18 years and older
Body mass index (BMI) between 18 and 32 kg/m2, inclusive
Weight 40 - 100 kg
In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations
Willing to use acceptable contraceptive measures as defined by the protocol
Agreeable to, and deemed able to by the investigator, to comply with the requirements of the study, including the follow-up period
Willing to abstain from the use of drugs of abuse while enrolled in the study

Exclusion criteria

History or clinically significant manifestations of disorders
History of acute allergic reaction 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
Males who have a pregnant female partner
Donation of plasma within 7 days prior to study drug administration
Donation or loss of whole blood
Receipt of blood products within 2 months before initiation of dosing on Day 1
History of malignancy within 10 years of screening except completely excised basal cell carcinoma or squamous cell carcinoma of the skin
History of severe systemic bacterial, fungal, or parasitic infections associated with more than two hospitalizations per year or more than two courses of intravenous (IV) antibiotics within 1 year
Received oral antibiotics within 4 weeks before initiation of dosing on Day 1, or IV antibiotics within 8 weeks before initiation of dosing
Hospitalization within 4 weeks before initiation of dosing on Day 1
Use of any over the counter or prescription medications/products within 7 days prior to Day 1 and unwilling to abstain from the use of such drugs up until at least the Day 29 study visit, unless deemed acceptable by the investigator and Sponsor
Participation in a clinical trial within 4 weeks
Received any vaccine within 14 days prior to screening
Positive blood test for chronic viral infections