Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects

NCT01486823 | Completed Phase 1 DMC

• 1 other identifier: 11-BI-204-02
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study in healthy volunteers designed to investigate the PK following intravenous and subcutaneous administration of MLDL1278A (also known as BI-204). The bioavalialbility of MLDL1278A after subcutaneous administration will be determined.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration versus time curve (AUC) of MLDL1278A.

  Up to 70 days post administration.

Secondary Outcomes (4)

• Peak plasma concentration (Cmax) of MLDL1278A.

  Up to 70 days post administration.

• Plasma clearance (CL) of MLDL1278A.

  Up to 70 days post administration.

• Number of participants with an anti therapeutic antibody (ATA) response.

  Up to 140 days post administration.

• Number of participants with adverse events.

  Up to 140 days post administration.

Study Arms (2)

Cohort A

EXPERIMENTAL

Drug: MLDL1278A

Cohort B

EXPERIMENTAL

Drug: MLDL1278A

Interventions

MLDL1278A DRUG

Single intravenous dose of 360 mg MLDL1278A followed by a single subcutaneous dose of 360 mg MLDL1278A.

Cohort A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult males/females aged 18 to 55 years inclusive at screening;
• Subjects who are between 18.0 and 30.0 kg/m2 body mass index (BMI) inclusive and weigh between 55.0 and 100.0 kg inclusive;

You may not qualify if:

• Any clinically relevant disease or disorder (past or present), which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study;
• Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, coagulation, urinalysis, vital signs or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk because of his participation in the study;

Sponsors & Collaborators

• BioInvent International AB: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Quintiles Drug Research Unit at Guy's Hospital

London, SE1 1YHR, United Kingdom

Location

MeSH Terms

Interventions

MLDL1278A

Study Officials

• Darren Wilbraham, MD

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: December 7, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

GB (1)