Healthy Volunteer
Conditions
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.
Interventions
DRUGMHAB5553A
Single intravenous administration, at various doses, depending on the cohort
DRUGMatching placebo
Single intravenous dose
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Terminal elimination half-life (t1/2) of MHAB5553A | Up to 120 days |
| Maximum serum concentration (Cmax) of MHAB5553A | Up to 120 days |
| Mean Residence Time (MRT) 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 |
Countries
Canada
Outcome results
None listed