NCT03853421

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Modus Therapeutics AB · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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).

Conditions

• Safety and Tolerability

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-06
• Primary completion: 2019-05-06
• Completion: 2019-05-06
• First posted: 2019-02-25
• Last updated: 2019-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study