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

NCT ID: NCT01486823

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Cohort A

Group Type EXPERIMENTAL

MLDL1278A

Intervention Type DRUG

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

Cohort B

Group Type EXPERIMENTAL

MLDL1278A

Intervention Type DRUG

Single subcutaneous dose of 360 mg MLDL1278A.

Interventions

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MLDL1278A

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

Intervention Type DRUG

MLDL1278A

Single subcutaneous dose of 360 mg MLDL1278A.

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

BioInvent International AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Darren Wilbraham, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

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Quintiles Drug Research Unit at Guy's Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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11-BI-204-02

Identifier Type: -

Identifier Source: org_study_id