A Study of High Dose MHAA4549A in Healthy Volunteers

NCT ID: NCT02284607

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-03
• Study Completion Date: 2015-03-13

Brief Summary

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

MHAA4549A higher dose

Group Type: EXPERIMENTAL

MHAA4549A

Intervention Type: DRUG

MHAA4549A single, intravenous dose administration, higher dose level

MHAA4549A lower dose

Group Type: EXPERIMENTAL

MHAA4549A

Intervention Type: DRUG

MHAA4549A single, intravenous dose administration, lower dose level

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo to MHAA4549A administration

Interventions

MHAA4549A

MHAA4549A single, intravenous dose administration, lower dose level

Intervention Type: DRUG

MHAA4549A

MHAA4549A single, intravenous dose administration, higher dose level

Intervention Type: DRUG

Placebo

Matching placebo to MHAA4549A administration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

inVentiv Health Clinique

Québec, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 27381392 (View on PubMed)

Other Identifiers

GV29609

Identifier Type: -

Identifier Source: org_study_id