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

• ClinicalTrials.gov Identifier: NCT03853421
• Recruitment Status: Completed
• First Posted: February 25, 2019
• Last Update Posted: July 16, 2019
• Sponsor: Modus Therapeutics AB
• Information provided by (Responsible Party): Modus Therapeutics AB

Tracking Information

• First Submitted Date: February 15, 2019
• First Posted Date: February 25, 2019
• Last Update Posted Date: July 16, 2019
• Actual Study Start Date: February 6, 2019
• Actual Primary Completion Date: May 6, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Placebo-controlled Study to Determine the Safety and Tolerability of Subcutaneous Doses of Sevuparin
• Official Title: 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: Interventional
• Study Phase: Phase 1

Study Design

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: Safety and Tolerability

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 22, 2019): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 6, 2019
• Actual Primary Completion Date: May 6, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03853421
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Modus Therapeutics AB
• Study Sponsor: Modus Therapeutics AB
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Modus Therapeutics AB
• Verification Date: February 2019