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

Momenta Pharmaceuticals, Inc.0 sites70 target enrollmentFebruary 19, 2019

ConditionsImmune thrombocytopenic purpura MedDRA version: 20.1Level: PTClassification code 10074667Term: Immune thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disorders Therapeutic area: Diseases [C] - Immune System Diseases [C20]

DrugsPrivigen®

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Immune thrombocytopenic purpura
Sponsor: Momenta Pharmaceuticals, Inc.
Enrollment: 70
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 19, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Momenta Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Participant must be \= 18 and \= 55 years of age inclusive, at the time of signing the informed consent form (ICF).
•2\. Good health as indicated by medical history (without hemolysis or thrombosis that may impact current study), physical examination, vital signs (with systolic blood pressure below 140 mmHg), clinical laboratory tests, and 12\-lead electrocardiogram, and all abnormal findings are assessed as not clinically significant by the Investigator.
•3\. Body weight must be between 50 and 110 kg, inclusive, and body mass index (BMI) between 18\.5 and 30 kg/m2, inclusive, at screening.
•4\. Healthy male and females are eligible.
•a.Male participants:
•If male, surgically or biologically sterile. If not sterile, agreement to use an acceptable form of birth control with sexual partner or abstain from sexual relations for 100 days following the last treatment.
•b. Female participants:
•A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
•? Not a woman of childbearing potential (WOCBP) (Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or of non\-childbearing potential (i.e., postmenopausal for at least 1 year).
•? A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 90 days after the last dose of study intervention.

Exclusion Criteria

•1\. Previously received M254\.
•2\. History of any drug allergy, hypersensitivity, or intolerance to any drug product that in the opinion of the Investigator would place the subject at particular risk and compromise the safety of the subject in the
•3\. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, psychiatric disease, or any other condition, that in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
•4\. History of splenectomy, asthma (with the exception of childhood asthma that has resolved), chronic obstructive pulmonary disease, or recurrent or current gastrointestinal or respiratory infections.
•5\. Any illness within 5 days, or clinically significant airway infections within 30 days, prior to first study drug dosing.
•6\. On fluid restriction.
•7\. Any prescription medication(s) within 14 days of dose administration (or 5 half\-lives, whichever is longer) or any non\-prescribed systemic or topical medication (including any herbal product) within 7 days prior to dose administration.
•8\. Plans to participate in another clinical trial while enrolled in this study and/or received an investigational drug and/or device within 60 days prior to dose administration.
•9\. Positive urine drug screen at screening.
•10\. Positivity for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at screening.