A Study of the Safety, Tolerability, Pharmacokinetics, and Bioavailability of IV and SC MABT5102A in Healthy Volunteers

NCT00997919 | Completed Phase 1

• 1 other identifier: ABE4662g
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Phase I, single-dose, randomized, parallel-group, open-label study will evaluate the safety, tolerability, and pharmacokinetics of MABT5102A following subcutaneous (SC) and intravenous (IV) administration in healthy volunteers.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Safety (adverse events, laboratory abnormalities, physical and neurological examination findings, vital signs, electrocardiogram (ECG) results)

  Until study discontinuation

Secondary Outcomes (1)

• Pharmacokinetic/Pharmacodynamic (area under the concentration-time curve, volume of distribution, clearance [CL] and apparent CL, terminal half-life)

  Until study discontinuation

Study Arms (2)

A

EXPERIMENTAL

Drug: MABT5102A

B

EXPERIMENTAL

Drug: MABT5102A

Interventions

MABT5102A DRUG

single SC dose

A

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects aged 18-50 years and female subjects aged 18-50 years who are not of childbearing potential and who are in good general health at the screening visit
• Body weight between 50 and 100 kg
• For male subjects of reproductive potential, a reliable means of contraception must be used (e.g., abstinence or a condom) for the duration of the study

You may not qualify if:

• Female subjects with reproductive potential.
• Subjects with evidence of clinically significant neurologic, psychiatric, hepatic, renal, hematologic, pulmonary, respiratory, immunologic system abnormalities, acute infection, or other unstable medical disease
• Subjects with any malignancy (with the exception of completely excised basal cell or squamous cell carcinoma of the skin)
• History of alcohol, drug, or substance abuse within 6 months prior to randomization that, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study
• Past history of seizures, with the exception of childhood febrile seizures
• Clinically significant laboratory or ECG abnormalities
• Hospitalization during the 4 weeks prior to screening

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Interventions

crenezumab

Study Officials

• Robert Paul, Ph.D., M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2009
• First Posted: October 20, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: May 30, 2017

Record last verified: 2017-05