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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral hymecromone 400mg po three times per day | Active Comparator | Participants will be administered oral hymecromone 400mg po three times per day (1200 mg) |
|
| Oral hymecromone 800 mg po three times per day (2400 mg) | Active Comparator | Participants will be be administered oral hymecromone 800 mg po three times per day (2400 mg) |
|
| Oral hymecromone 1200 mg three times per day (3600 mg) | Active Comparator | Participants will be administered oral hymecromone 1200 mg three times per day (3600 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hymecromone | Drug | Oral Hymecromone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in sputum hyaluronan concentration over the study period | From baseline to day 4 | |
| Change in serum hyaluronan concentration over the study period | From baseline to day 4 | |
| Change in serum hymecromone concentration over the study period | From baseline to day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability (as codified by Common Terminology Criteria for Adverse Events (CTCAE) v5.0) of oral hymecromone over the study period | Through study completion, an average of 11 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Bollyky, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37055910 | Derived | Salman L, Martinez L, Faddoul G, Manning C, Ali K, Salman M, Vazquez-Padron R. Hyaluronan Inhibition as a Therapeutic Target for Diabetic Kidney Disease: What Is Next? Kidney360. 2023 Jun 1;4(6):e851-e860. doi: 10.34067/KID.0000000000000126. Epub 2023 Apr 14. | |
| 35499083 | Derived | Rosser JI, Nagy N, Goel R, Kaber G, Demirdjian S, Saxena J, Bollyky JB, Frymoyer AR, Pacheco-Navarro AE, Burgener EB, Rajadas J, Wang Z, Arbach O, Dunn CE, Kalinowski A, Milla CE, Bollyky PL. Oral hymecromone decreases hyaluronan in human study participants. J Clin Invest. 2022 May 2;132(9):e157983. doi: 10.1172/JCI157983. |
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| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D006923 | Hymecromone |
| ID | Term |
|---|---|
| D014468 | Umbelliferones |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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Participants will be assigned to one of three treatment groups, each including up to 6 participants, with treatment over 4 days of different doses of oral hymecromone. Following a wash-out period, participants are allowed to re-enroll into different treatment groups to provide intra-patient dose comparisons.
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|
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |