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

Safety and Tolerability Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03853421
Study type Interventional
Source Modus Therapeutics AB
Contact
Status Completed
Phase Phase 1
Start date February 6, 2019
Completion date May 6, 2019
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