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Trial record 1 of 3 for:    sevuparin
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Placebo-controlled Study to Determine the Safety and Tolerability of Subcutaneous Doses of Sevuparin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03853421
Recruitment Status : Completed
First Posted : February 25, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Modus Therapeutics AB

Tracking Information
First Submitted Date  ICMJE February 15, 2019
First Posted Date  ICMJE February 25, 2019
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE February 6, 2019
Actual Primary Completion Date May 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
  • 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],
  • 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]).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Placebo-controlled Study to Determine the Safety and Tolerability of Subcutaneous Doses of Sevuparin
Official Title  ICMJE A Double-blind, Placebo-controlled Study in Healthy Volunteers to Determine the Safety and Tolerability of Single, Ascending Subcutaneous Doses of Sevuparin
Brief Summary A Double-blind, Placebo-controlled study in Healthy Volunteers to Determine the Safety and Tolerability of Single, Ascending Subcutaneous Doses of Sevuparin
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Safety and Tolerability
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Sevuparin
  • 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.
    Intervention: Drug: Sevuparin
  • 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.
    Intervention: Drug: Sevuparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 6, 2019
Actual Primary Completion Date May 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03853421
Other Study ID Numbers  ICMJE PKSC01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Modus Therapeutics AB
Study Sponsor  ICMJE Modus Therapeutics AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Modus Therapeutics AB
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP