Study oversight
PD, SAD
BLIND
The present study is a phase 1, first‐in‐human double blind, randomized, placebo‐controlled trial, in male healthy volunteers, consisting of a single ascending dose (SAD) adaptive design with a food interaction (FI) arm, and a multiple ascending dose (MAD) design, to evaluate the safety, tolerability, PK and pharmacodynamics (PD) of KCL‐286. (Trial ID: The trial, protocol amendments, informed consent forms, investigator's brochure and any other relevant information were reviewed and approved by the London‐Surrey Borders Research Ethics Committee. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.The trial was conducted from July 2018 to December 2021 at 2 sites in the UK. All participants provided written informed consent.