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Clinical Trials/NL-OMON49624
NL-OMON49624
Completed
Phase 2

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. - Safety and tolerability of M254 in HV and ITP patients.

Momenta Pharmaceuticals, Inc.0 sites30 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Momenta Pharmaceuticals, Inc.
Enrollment
30
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

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
  • •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.

Outcomes

Primary Outcomes

Not specified

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