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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 26, 2016

Interventions

  • Drug: MHAB5553A
    • Single intravenous administration, at various doses, depending on the cohort
  • Drug: Matching placebo
    • Single intravenous dose

Arms, Groups and Cohorts

  • Experimental: Cohort A
  • Experimental: Cohort B
  • Experimental: Cohort C
  • Experimental: Cohort D
  • Experimental: Cohort E

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Genentech, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Hoffmann-La Roche

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