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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528903
• Other study ID #: GV29827
• Status: Completed
• Phase: Phase 1
• Start date: August 18, 2015
• Est. completion date: January 26, 2016

Study information

• Verified date: September 2019
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 26, 2016
• Est. primary completion date: January 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

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

Locations

Country	Name	City	State
Canada	inVentiv Health Clinique	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events, graded by severity		Until study discontinuation/termination, up to 120 days
Primary	Changes in vital signs during and following MHAB5553A administration		Throughout the study, up to 120 days
Primary	Changes in physical examination finding during and following MHAB5553A administration		Throughout the study, up to 120 days
Primary	Changes in clinical laboratory results during and following MHAB5553A administration		Throughout the study, up to 120 days
Primary	Changes in electrocardiogram (ECG) findings during and following MHAB5553A		Throughout the study, up to 120 days
Primary	Incidence of serum anti-MHAB5553A antibodies		Until study discontinuation/termination, up to 120 days
Secondary	Maximum serum concentration (Cmax) of MHAB5553A		Up to 120 days
Secondary	Time to Cmax (tmax) of MHAB5553A		Up to 120 days
Secondary	Area under the concentration-time curve up to last measurable time point (AUC0-last) of MHAB5553A		Up to 120 days
Secondary	Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of MHAB5553A		Up to 120 days
Secondary	Clearance (CL) of MHAB5553A		Up to 120 days
Secondary	Volume of distribution at steady-state (Vss) of MHAB5553A		Up to 120 days
Secondary	Terminal elimination half-life (t1/2) of MHAB5553A		Up to 120 days
Secondary	Mean Residence Time (MRT) of MHAB5553A		Up to 120 days