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

Healthy Volunteer Clinical Trial

Official title:

A Phase I, Single-Dose, Randomized, Parallel-Group, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Bioavailability of IV and SC MABT5102A in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997919
• Other study ID #: ABE4662g
• Status: Completed
• Phase: Phase 1
• First received: October 19, 2009
• Last updated: May 25, 2017
• Start date: October 2009
• Est. completion date: February 2010

Study information

• Verified date: May 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• MABT5102A
single SC dose
• MABT5102A
single IV dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (adverse events, laboratory abnormalities, physical and neurological examination findings, vital signs, electrocardiogram (ECG) results)		Until study discontinuation
Secondary	Pharmacokinetic/Pharmacodynamic (area under the concentration-time curve, volume of distribution, clearance [CL] and apparent CL, terminal half-life)		Until study discontinuation