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Purpose

This is a Phase 1b, double-blind (participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with acute submassive pulmonary embolism.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male or female subjects, age 18 to 75 years admitted to hospital with a clinical diagnosis of acute pulmonary embolism (PE) categorized as low risk or intermediate-risk or submassive PE and for whom catheter-based therapy is not planned; - Subjects must have a computed tomography angiography (CTA) scan confirming the PE diagnosis and with at least one measurable index lesion in a segmental or larger pulmonary artery prior to randomization; - Subjects should be in otherwise satisfactory health in the opinion of the Investigator; - Subjects must be able to provide written informed consent.

Exclusion Criteria

  • Subjects with acute PE categorized as high-risk or massive, or who are hemodynamically unstable, evidenced by a heart rate > 120 /min and a systolic blood pressure (SBP) of < 90 mmHg for more than 15 consecutive minutes or a drop in SBP of > 40 mmHg since presentation; - Subjects for whom use of a thrombolytic, either systemic or via catheter, is planned; - Subjects with PE lesions only in the sub-segmental or smaller arteries; - Subjects receiving any vitamin K antagonists (VKAs) prior to randomization or receiving more than 36 hours treatment with low molecular weight (LMW) Heparin in therapeutic doses prior to randomization; - Subjects who had a prior intracranial hemorrhage, known arteriovenous malformation or aneurysm, head trauma, or evidence of active bleeding; - Subjects who within 48 hours of randomization have used an anti-Factor IIa agent such as dabigatran or an anti-FXa agent such as rivaroxaban, apixaban, or edoxaban; - Subjects who within 21 days prior to randomization have had gastrointestinal or genitourinary bleeding; - Subjects who within 14 days prior to randomization have had major surgery or a lumbar puncture (or epidural steroid injection); - Subjects with diagnosed active liver disease or with elevation of liver enzymes/bilirubin.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
DS-1040b 		Participants who are randomized to receive DS-1040b as a single, continuous intravenous infusion (initial loading dose 3-6 mg). All participants will also receive standard of care anticoagulation enoxaparin therapy during the study drug infusion.
  • Drug: DS-1040b
    Single, continuous intravenous infusion over 12 to 24 hours (depending on cohort)
  • Drug: Enoxaparin
    Subcutaneous injection 1 mg/kg twice daily
Placebo Comparator
Placebo 		Participants who are randomized to receive placebo as a single, continuous intravenous infusion. All participants will also receive standard of care anticoagulation enoxaparin therapy during the study drug infusion.
  • Drug: Placebo
    Single, continuous intravenous infusion of 0.9% sodium chloride over 12 to 24 hours
  • Drug: Enoxaparin
    Subcutaneous injection 1 mg/kg twice daily

More Details

Status
Completed
Sponsor
Daiichi Sankyo

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.