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

NCT02528903 | Completed Phase 1

• 1 other identifier: GV29827
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• 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

Study Arms (5)

Cohort A

EXPERIMENTAL

Drug: MHAB5553A; Drug: Matching placebo

Cohort B

EXPERIMENTAL

Drug: MHAB5553A; Drug: Matching placebo

Cohort C

EXPERIMENTAL

Drug: MHAB5553A; Drug: Matching placebo

Cohort D

EXPERIMENTAL

Drug: MHAB5553A; Drug: Matching placebo

Cohort E

EXPERIMENTAL

Drug: MHAB5553A; Drug: Matching placebo

Interventions

MHAB5553A DRUG

Single intravenous administration, at various doses, depending on the cohort

Cohort A; Cohort B; Cohort C; Cohort D; Cohort E

Matching placebo DRUG

Single intravenous dose

Cohort A; Cohort B; Cohort C; Cohort D; Cohort E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

inVentiv Health Clinique

Québec, G1P 0A2, Canada

Location

Related Publications (1)

• 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.

  PMID: 28559255 DERIVED

MeSH Terms

Interventions

lesofavumab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 19, 2015
• Study Start: August 18, 2015
• Primary Completion: January 26, 2016
• Study Completion: January 26, 2016
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

CA (1)