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Placebo-controlled Study to Determine the Safety and Tolerability of Subcutaneous Doses of Sevuparin

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ClinicalTrials.gov Identifier: NCT03853421
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Modus Therapeutics AB

Brief Summary:
A Double-blind, Placebo-controlled study in Healthy Volunteers to Determine the Safety and Tolerability of Single, Ascending Subcutaneous Doses of Sevuparin

Condition or disease Intervention/treatment Phase
Safety and Tolerability Drug: Sevuparin Phase 1

Detailed Description:
This is a randomized, double-blind, placebo-controlled, sequential cohort, single escalating dose study to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of sevuparin in healthy volunteer adult male and female subjects. The study will consist of three subcutaneous dose cohorts (3, 6 and 9 mg/kg sevuparin). Each dosing cohort will consist of 8 subjects who will be randomized to receive either a single dose of sevuparin or matching placebo in a 3:1 ratio (6 active/2 placebo).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The clinical study will be performed in a double-blind manner. Only the site pharmacy personnel, who are responsible for preparing the study drug, will have knowledge of the treatment assigned
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study in Healthy Volunteers to Determine the Safety and Tolerability of Single, Ascending Subcutaneous Doses of Sevuparin
Actual Study Start Date : February 6, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : August 30, 2019

Arm Intervention/treatment
Experimental: Dose cohort 3 mg/kg sevuparin
The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1.
Drug: Sevuparin
The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1.

Experimental: Dose cohort 6 mg/kg sevuparin
The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1.
Drug: Sevuparin
The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1.

Experimental: Dose cohort 9 mg/kg sevuparin
The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1.
Drug: Sevuparin
The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1.




Primary Outcome Measures :
  1. To determine the safety and tolerability of single ascending subcutaneous doses of sevuparin in healthy male and female subjects. [ Time Frame: From baseline until day 28 ]
    Number of participants with treatment-related adverse events as assessed by CTCAE


Secondary Outcome Measures :
  1. PK characteristics of sevuparin during and after administration of sevuparin as a single subcutanous injection (3 dose co-horts). [ Time Frame: Pre dose until day 3 ]
    Maximum Plasma Concentration [Cmax],

  2. PK characteristics of sevuparin during and after administration of sevuparin as a single subcutanous injection (3 dose co-horts). [ Time Frame: Pre dose until day 3 ]
    Area Under the Curve [AUC]).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed consent form is signed and dated
  • Adult male or female subjects, aged ≥18 to ≤65 years of age inclusive;
  • Body mass index ≥19.0 to ≤29.0 kg/m2 and a body weight 50.0-100.0 kg
  • Subjects must have a negative pregnancy test and subjects of childbearing potential must either be surgically sterile or be willing to practice a highly effective method of contraception
  • Subjects must be in good health, as determined by a medical history, physical examination
  • Subjects with no clinically significant and relevant history that could affect the conduct of the study.

Exclusion Criteria:

  • Recent trauma or injury or history of clinically significant bleeding.
  • Clinical evidence of significant or unstable medical illness
  • Subjects who have received any prescribed systemic or topical medication
  • Subjects who have received aspirin, anti-platelet therapy, anticoagulant therapy and prophylactic and therapeutic LMWH or un-fractioned heparin.
  • Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies)
  • Subjects who have received any medications known to chronically alter drug absorption or elimination processes
  • Subjects who are still participating in a clinical study
  • Subjects who have donated any blood, plasma or platelets
  • Subjects with a significant history of drug allergy
  • Subjects who have any clinically significant allergic disease
  • Subjects who have a supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively
  • Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as QTcF interval > 470 ms, or with sinus rhythm with PR interval <110 ms or >210 ms, confirmed by a repeat ECG.
  • Screening transaminases (AST, ALT, GGT) ≥ 1.5 times the ULN; estimated glomerular filtration rate (GFR, MDRD equation) < 60 mL/min; APTT above the normal range, INR above 1.4; absolute platelet count <150,000/μL.
  • Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.
  • Subjects with a positive urine drug screen/alcohol test result
  • Subjects who smoke more than 6 cigarettes
  • Subjects who have positive hepatitis B or hepatitis C antibody or HIV antibodies.
  • Subjects who test positive for HIT antibodies at Screening.
  • Any relevant condition, behavior, laboratory value or concomitant medication which, in the opinion of the investigator, makes the subject unsuitable for entry into the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853421


Contacts
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Contact: John Öhd, MD, PhD +46705082291 john.ohd@modus.com

Locations
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United States, Florida
Clinical Pharmacology of Miami (CPMI) Recruiting
Miami, Florida, United States, 33014
Contact: Maria Bermudez, MD    305-817-2900    mbermudez@ergclinical.com   
Sponsors and Collaborators
Modus Therapeutics AB

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Responsible Party: Modus Therapeutics AB
ClinicalTrials.gov Identifier: NCT03853421     History of Changes
Other Study ID Numbers: PKSC01
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action