A 4-part Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 in healthy volunteers and in patients with immune thrombocytopenic purpura.

Phase 2

Completed

Conditions: immune thrombocytopenia
10035534

Registration Number: NL-OMON49624

Lead Sponsor: Momenta Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

healthy male or female subjects
18 - 55 years of age
Weight: body weight must be within a range that allows for the planned M254
infusion time to be completed in * 4 hours.
BMI 18.5 - 30 kilograms/meter2
Patients:
male or female diagnosed with ITP for at least 3 months
18 years and older

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of
participation in another drug study within 90 days before the start of this
study or being a blood donor within 30 days from the start of the study. In
case of donating more than 1.5 liters of blood in the 10 months prior the start
of this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part A: To assess the safety and tolerability of a single ascending dose of<br /><br>intravenous administration of M254 in healthy volunteers.<br /><br>Part B: To assess the safety and tolerability of a single intravenous<br /><br>administration of M254 in immune thrombocytopenia<br /><br>patients compared to 1000 mg/kg intravenous Privigen<br /><br>Part C: To assess the safety of a single intravenous administration of M254<br /><br>compared to 1000 mg/kg of Privigen<br /><br>To characterize the PD of single intravenous administration of M254 compared to<br /><br>1000 mg/kg Privigen<br /><br>Part D: To assess the safety and tolerability of repeated intravenous<br /><br>administration of M254 in ITP patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part A: To characterize the pharmacokinetics (PK) of a single intravenous<br /><br>administration of M254 at different doses in healthy volunteers<br /><br>Part B: To characterize the PK of a single intravenous administration of M254<br /><br>at different doses in ITP patients<br /><br>Part C: To characterize the PK of a single intravenous administration of M254<br /><br>at different doses.<br /><br>Part D: To characterize the PK of repeated intravenous doses of M254 in ITP<br /><br>patients and to assess PD of repeated intravenous doses of M254 in ITP patients</p><br>