The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have approved Kanna Health’s Investigational New Drug (IND) application and Clinical Trial Application (CTA), respectively, to start participant enrollment in a Phase 1 first-in-human clinical trial investigating the Safety and Pharmacokinetics of KH-001 Besylate (KH-001) in Healthy Male Subjects.
KH-001 is a unique, proprietary on-demand drug being developed as the first FDA-approved treatment for premature ejaculation. These regulatory approvals signify a potential breakthrough in the management of a widespread condition, impacting up to 20% of men and their partners worldwide.
The Phase 1 study will be conducted in the UK by Simbec-Orion, an experienced full-service Contract Research Organization (CRO).
Dr Ryan Protzko, Kanna Health’s President, stated: “Our clinical trial approval on both sides of the Atlantic represents a critical milestone as we officially become a clinical stage company. The study marks the start of a journey towards understanding the therapeutic potential of KH-001 in humans, in cooperation with regulatory bodies in our priority markets.”
“This approval allows Kanna Health to advance our understanding of how KH-001 may provide patients with a potentially transformative therapy, where no drug treatments are approved in the US and few treatment options exist worldwide”, said Dr Hans-Juergen Gruss, Kanna Health’s Chief Medical Officer.
