Condition: Olmsted Syndrome · Sponsor: Orvida Pharma (formerly Kamari Pharma)
The trial is conducted in order to assess the safety of KM-023 and to observe what effects, both beneficial and adverse, it has on the body, and the way the body absorbs and eliminates KM-023, first in healthy participants, then in Olmsted Syndrome patients. In addition, the study will examine the presence of KM-023 in the different layers of the skin. Finally, the efficacy of KM-023 will be investigated in Olmsted Syndrome patients. The first part of this trial will be conducted with healthy participants in France, then after its completion, the second part of the trial will be conducted with Olmsted Syndrome patients in France and the United Kingdom. The first part of the trial is itself divided in two parts: first, a series of single doses will be given to groups of healthy participants, then other groups of healthy participants will be given repeated doses of KM-023 twice daily for 5 days. The participants will be hospitalized approximately 2 days for the investigation of single doses, and approximately 8 days for the investigation of the multiple doses. Some participants will receive the KM-023, and other will receive a placebo, which is a non-active product. Four (4) different dose levels will be given in the trial part studying single administration, and 3 different dose levels in the trial part studying repeated administrations. The trial will start with the lowest doses, and the dose levels will be gradually increased after the safety and tolerability of the pre…
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| Northwestern University, Department of Dermatology | Chicago, Illinois, United States | Recruiting |
| Paris Descartes Necker Cochin, Hôpital Necker-Enfants Malades Bat Imagine RDC | Paris, France | Recruiting |
| Biotrial | Rennes, France | Recruiting |
| Royal London Hospital | London, United Kingdom | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07090889