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

NCT03853421 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PKSC01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety and Tolerability

Outcome Measures

Primary Outcomes (1)

• To determine the safety and tolerability of single ascending subcutaneous doses of sevuparin in healthy male and female subjects.

  Number of participants with treatment-related adverse events as assessed by CTCAE

  From baseline until day 28

Secondary Outcomes (2)

• PK characteristics of sevuparin during and after administration of sevuparin as a single subcutanous injection (3 dose co-horts).

  Pre dose until day 3

• PK characteristics of sevuparin during and after administration of sevuparin as a single subcutanous injection (3 dose co-horts).

  Pre dose until day 3

Study Arms (3)

Dose cohort 3 mg/kg sevuparin

EXPERIMENTAL

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

Dose cohort 6 mg/kg sevuparin

EXPERIMENTAL

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

Dose cohort 9 mg/kg sevuparin

EXPERIMENTAL

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

Interventions

Sevuparin DRUG

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.

Dose cohort 3 mg/kg sevuparin; Dose cohort 6 mg/kg sevuparin; Dose cohort 9 mg/kg sevuparin

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Modus Therapeutics AB: lead

Study Sites (1)

Clinical Pharmacology of Miami (CPMI)

Miami, Florida, 33014, United States

Location

MeSH Terms

Interventions

sevuparin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: February 15, 2019
• First Posted: February 25, 2019
• Study Start: February 6, 2019
• Primary Completion: May 6, 2019
• Study Completion: May 6, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-02

Locations

US (1)