NCT03542435

Randomized, Double-Blind, Placebo-Controlled, MAD Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023 When Administered Orally to Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Promentis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	SXC-2023	Oral capsule
DRUG	Placebo	Placebo

Timeline

• Start date: 2018-04-26
• Primary completion: 2018-08-08
• Completion: 2018-09-10
• First posted: 2018-05-31
• Last updated: 2018-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study