Status:
COMPLETED
Placebo-controlled Study to Determine the Safety and Tolerability of Subcutaneous Doses of Sevuparin
Lead Sponsor:
Modus Therapeutics AB
Conditions:
Safety and Tolerability
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
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 healt...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03853421
Start Date
February 6 2019
End Date
May 6 2019
Last Update
July 16 2019
Active Locations (1)
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1
Clinical Pharmacology of Miami (CPMI)
Miami, Florida, United States, 33014