NCT04630366

A Phase 1, First Time in Humans Study of NST-1024

A Phase 1, First Time in Man Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NST-1024 in Healthy Subjects and Otherwise Healthy Subjects With Elevated Triglycerides

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: NorthSea Therapeutics B.V. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

A first time in man study of NST-1024

Detailed description

A Phase 1, First Time in Man Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NST-1024 in Healthy Subjects and Otherwise Healthy Subjects with Elevated Triglycerides. This will be a double-blind, randomised, placebo-controlled, single and multiple oral dose study conducted in 2 parts. In part A up to 6 cohorts of 8 healthy volunteers will receive single ascending doses of NST-1024 or matching placebo. I part B up to 4 cohorts of 10 otherwise healthy volunteers, with elevated triglycerides will receive daily multiple ascending doses of NST-1024 for 14 days

Conditions

• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	NST-1024	NST-1024
DRUG	Placebo	Matching placebo to NST-1024

Timeline

• Start date: 2020-10-27
• Primary completion: 2022-06-20
• Completion: 2022-06-20
• First posted: 2020-11-16
• Last updated: 2022-12-02

Locations

1 site across 1 country: United Kingdom