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

NCT ID: NCT02528903

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-18
• Study Completion Date: 2016-01-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Cohort A

Group Type: EXPERIMENTAL

MHAB5553A

Intervention Type: DRUG

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

Matching placebo

Intervention Type: DRUG

Single intravenous dose

Cohort B

Group Type: EXPERIMENTAL

MHAB5553A

Intervention Type: DRUG

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

Matching placebo

Intervention Type: DRUG

Single intravenous dose

Cohort C

Group Type: EXPERIMENTAL

MHAB5553A

Intervention Type: DRUG

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

Matching placebo

Intervention Type: DRUG

Single intravenous dose

Cohort D

Group Type: EXPERIMENTAL

MHAB5553A

Intervention Type: DRUG

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

Matching placebo

Intervention Type: DRUG

Single intravenous dose

Cohort E

Group Type: EXPERIMENTAL

MHAB5553A

Intervention Type: DRUG

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

Matching placebo

Intervention Type: DRUG

Single intravenous dose

Interventions

MHAB5553A

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

Intervention Type: DRUG

Matching placebo

Single intravenous dose

Intervention Type: DRUG

Eligibility Criteria

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

• 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, , Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28559255 (View on PubMed)

Other Identifiers

GV29827

Identifier Type: -

Identifier Source: org_study_id