Bioavailability Study of MLDL1278A After Subcutaneous and... | NCT01486823

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

NCT01486823

Sponsor

BioInvent International AB

Status

Completed

Last Update Posted

Dec 11, 2012Estimated

Enrollment

22Actual

Phase

Phase 1

Conditions

Healthy

Interventions

MLDL1278A
MLDL1278A

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Nov 22, 2011

First Submission Date that Met QC Criteria

Dec 6, 2011

First Posted Date

Dec 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2012

Last Update Posted Date

Dec 11, 2012Estimated

Name	Class
Genentech, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort A	Experimental		Drug: MLDL1278A
Cohort B	Experimental		Drug: MLDL1278A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MLDL1278A	Drug	Single intravenous dose of 360 mg MLDL1278A followed by a single subcutaneous dose of 360 mg MLDL1278A.	Cohort A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the plasma concentration versus time curve (AUC) of MLDL1278A.		Up to 70 days post administration.

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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;

Exclusion Criteria:

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;

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Darren Wilbraham, MD	Quintiles, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Quintiles Drug Research Unit at Guy's Hospital		London		SE1 1YHR	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
C000604072	MLDL1278A

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided