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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: MLDL1278A

• Registration Number: NCT01486823
• Lead Sponsor: BioInvent International AB

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 available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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;

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A	MLDL1278A	-
Cohort B	MLDL1278A	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants with an anti therapeutic antibody (ATA) response.	Up to 140 days post administration.
Plasma clearance (CL) of MLDL1278A.	Up to 70 days post administration.
Peak plasma concentration (Cmax) of MLDL1278A.	Up to 70 days post administration.
Number of participants with adverse events.	Up to 140 days post administration.

Trial Locations

Locations (1)

Quintiles Drug Research Unit at Guy's Hospital; 🇬🇧 London, United Kingdom