NCT02780752

A Study of Oral Hymecromone and Hyaluronan Synthesis

Dose Ranging Studies of Oral Hymecromone on Hyaluronan Synthesis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Paul Bollyky · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to add further understanding to the doses of hymecromone that effectively and safely lead to the inhibition of hyaluronan synthesis. In this study we will investigate both circulating hyaluronan in the serum, as well as tissue hyaluronan, using sputum samples as a non-invasive surrogate. This is a parallel, open-label, single-center, dose-response study of hymecromone in healthy adults 18 years of age or older. Up to 18 participants will be enrolled. Participants will be treated for 4 days with study drug. Safety as well as biomarkers of pharmacokinetic and pharmacodynamic response will be monitored during therapy.

Conditions

• Healthy
• Respiratory Disease

Interventions

Type	Name	Description
DRUG	hymecromone	Oral Hymecromone

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-05-10
• Completion: 2021-05-10
• First posted: 2016-05-23
• Last updated: 2021-06-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study