A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- MHAB5553A
- Conditions
- Healthy Volunteer
- Sponsor
- Genentech, Inc.
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events, graded by severity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Arms & Interventions
Cohort A
Intervention: MHAB5553A
Cohort A
Intervention: Matching placebo
Cohort B
Intervention: MHAB5553A
Cohort B
Intervention: Matching placebo
Cohort C
Intervention: MHAB5553A
Cohort C
Intervention: Matching placebo
Cohort D
Intervention: MHAB5553A
Cohort D
Intervention: Matching placebo
Cohort E
Intervention: MHAB5553A
Cohort E
Intervention: Matching placebo
Outcomes
Primary Outcomes
Incidence of adverse events, graded by severity
Time Frame: Until study discontinuation/termination, 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 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
Changes in vital signs 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
Secondary Outcomes
- Clearance (CL) of MHAB5553A(Up to 120 days)
- Maximum serum concentration (Cmax) of MHAB5553A(Up to 120 days)
- Volume of distribution at steady-state (Vss) 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)
- Terminal elimination half-life (t1/2) 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 extrapolated to infinity (AUC0-inf) of MHAB5553A(Up to 120 days)