Phase
Condition
N/ATreatment
Point-of-Care Coagulometer (investigational device)
Ciraparantag
Placebo
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provide written informed consent.
18 to 75 years of age.
Be in generally good health
BMI 18 to 32 kg/m2, inclusive, at Screening.
If female, be surgically sterile or post-menopausal or if of child-bearingpotential, using an acceptable method of contraception (other than a combinationestrogen/progestin hormonal contraceptive) for at least 1 month prior to Day 1.
If male, be surgically sterile, or agree to use appropriate contraception.
Have suitable venous access for multiple venipunctures.
Exclusion
Exclusion Criteria:
Have any of the following findings at Screening:
Hemoglobin or hematocrit value outside the normal range
Platelet count outside the normal range
PT or aPTT outside the normal range
Plasma fibrinogen outside the normal range
Serum triglycerides or total cholesterol outside the normal range
Serum creatinine >1.5 mg/dL (133 μmol/L) or known renal disease
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x theupper limit of normal, or known liver disease
Total bilirubin outside the normal range
Positive viral screen for hepatitis B virus, hepatitis C virus (HCV), or humanimmunodeficiency virus (HIV)
Positive pregnancy test (females)
Positive drug, tobacco or alcohol screen
Any clinically significant findings on 12-lead ECG or urinalysis
Have a personal or family history of clotting disorder or hematologic abnormality.
Have a history of unexplained syncope.
Have a history within 6 months prior to Screening of major bleeding, trauma,surgical procedure of any type, or vaginal delivery
Have a history within 6 months prior to Screening of peptic ulcer orgastrointestinal bleeding.
Have received any blood product or anticoagulant within 3 months prior to Screening.
Have donated blood or blood products within 3 months prior to Screening
Have a history of minor bleeding episodes within 1 month prior to Screening, or along-standing history of such bleeding.
If female, have a history of excessive or dysfunctional uterine bleeding (unless thesubject had a subsequent hysterectomy).
Have used any tobacco or nicotine-containing products within 3 months prior toScreening.
Have used any systemic prescription or non-prescription drugs within 14 days priorto Day 1 (except for permitted contraceptives).
If female, be pregnant, breastfeeding, or planning to become pregnant during thestudy.
Have received ciraparantag in any prior clinical study.
Have received another investigational drug within 5 half-lives or 30 days, whicheveris longer, prior to Day 1.
Known allergy to edoxaban, apixaban or rivaroxaban.
Have any other condition that, in the opinion of the Investigator, would interferewith a subject's ability to adhere to the protocol, interfere with assessment of theinvestigational product, or compromise the safety of the subject or the quality ofthe data.
Study Design
Study Description
Connect with a study center
Qps-Mra, Llc.
South Miami, Florida 33143
United StatesSite Not Available
Frontage Clinical Services
Secaucus, New Jersey 07094
United StatesSite Not Available
ICON Early Phase Services, LLC
San Antonio, Texas 78209
United StatesSite Not Available
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