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OpenTrials
Completed

NCT Number: NCT01486823

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quintiles Drug Research Unit at Guy's Hospital

London, SE1 1YHR, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

MLDL1278A

Drug

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

Primary outcomes

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

    Time frame: Up to 70 days post administration.

Secondary outcomes

  1. Peak plasma concentration (Cmax) of MLDL1278A.

    Time frame: Up to 70 days post administration.

  2. Plasma clearance (CL) of MLDL1278A.

    Time frame: Up to 70 days post administration.

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

    Time frame: Up to 140 days post administration.

  4. Number of participants with adverse events.

    Time frame: Up to 140 days post administration.

Sponsors and collaborators

Lead sponsor

BioInvent International AB

Industry

Collaborators

  • Genentech, Inc.

Registry information

Official study title

An Open-label, Single-dose Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 7, 2011
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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