A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers

This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of MHAB5553A.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: MHAB5553A; Drug: Matching placebo

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1P 0A2
    • inVentiv Health Clinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed informed consent form (ICF)
• 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, and vital signs
• Clinical laboratory evaluations should be within reference range for the test, unless deemed not clinically significant by the investigator and sponsor at screening
• Willing to abstain from using drugs of abuse while enrolled in the study
• Willing and able to comply with protocol-specified criteria in regard to contraceptive protection
• Able to comply with the study protocol, in the investigator's judgment

Exclusion Criteria:

• History or clinically significant manifestations of metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders
• History of anaphylaxis, hypersensitivity or drug allergies, unless approved by the investigator and sponsor
• History or presence of an abnormal ECG, which, in the investigator's or sponsor's opinion, is clinically significant (including evidence of previous acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block)
• 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 or use of soft drugs (such as marijuana) within 3 months prior to screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening
• Current tobacco smokers (positive history within 3 months before initiation of dosing on Day 1), or those with positive cotinine test at check-in
• Positive drug screen at screening or at check-in
• Positive pregnancy test result at screening or Day -1 or breast feeding during the study
• Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe enrollment in and completion of the study
• Unwillingness to comply or other conditions that, in the opinion of the investigator, would interfere with the ability to comply with the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort B	Drug: MHAB5553A; Single intravenous administration, at various doses, depending on the cohort; Drug: Matching placebo; Single intravenous dose
Experimental: Cohort A	Drug: MHAB5553A; Single intravenous administration, at various doses, depending on the cohort; Drug: Matching placebo; Single intravenous dose
Experimental: Cohort C	Drug: MHAB5553A; Single intravenous administration, at various doses, depending on the cohort; Drug: Matching placebo; Single intravenous dose
Experimental: Cohort D	Drug: MHAB5553A; Single intravenous administration, at various doses, depending on the cohort; Drug: Matching placebo; Single intravenous dose
Experimental: Cohort E	Drug: MHAB5553A; Single intravenous administration, at various doses, depending on the cohort; Drug: Matching placebo; Single intravenous dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events, graded by severity	Until study discontinuation/termination, up to 120 days
Changes in vital signs during and following MHAB5553A administration	Throughout the study, up to 120 days
Changes in physical examination finding during and following MHAB5553A administration	Throughout the study, up to 120 days
Changes in clinical laboratory results during and following MHAB5553A administration	Throughout the study, up to 120 days
Changes in electrocardiogram (ECG) findings during and following MHAB5553A	Throughout the study, up to 120 days
Incidence of serum anti-MHAB5553A antibodies	Until study discontinuation/termination, up to 120 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum serum concentration (Cmax) of MHAB5553A	Up to 120 days
Time to Cmax (tmax) of MHAB5553A	Up to 120 days
Area under the concentration-time curve up to last measurable time point (AUC0-last) of MHAB5553A	Up to 120 days
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of MHAB5553A	Up to 120 days
Clearance (CL) of MHAB5553A	Up to 120 days
Volume of distribution at steady-state (Vss) of MHAB5553A	Up to 120 days
Terminal elimination half-life (t1/2) of MHAB5553A	Up to 120 days
Mean Residence Time (MRT) of MHAB5553A	Up to 120 days

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Publications and helpful links

General Publications

• Lim JJ, Derby MA, Zhang Y, Deng R, Larouche R, Anderson M, Maia M, Carrier S, Pelletier I, Girard J, Kulkarni P, Newton E, Tavel JA. A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza B Virus Monoclonal Antibody, MHAB5553A, in Healthy Volunteers. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00279-17. doi: 10.1128/AAC.00279-17. Print 2017 Aug.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2015
• Primary Completion (Actual): January 26, 2016
• Study Completion (Actual): January 26, 2016

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: GV29827