An adaptive, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to examine the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of RGH-338 in healthy male volunteers. - First-in-Human study of RGH-338

Gedeon Richter Plc.0 个研究点目标入组 200 人开始时间: 待定最近更新: 2024年6月11日

研究概览

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•1. Clinically relevant abnormal history, physical finding,12-lead safety ECG,
•or laboratory value at screening that could interfere with the objectives of
•the trial or the safety of the volunteer.
•2. Family history of seizures or a clinically significant psychiatric disorder.
•5. Risk of suicide, as judged by an Investigator, based upon available source
•information * including the C-SSRS or family history of suicide * indicating
•current suicidal ideation or a history of active suicidal ideation or suicide
•28. Positive SARS-CoV-2 PCR analysis prior to first dosing.
•29. Any current, clinically significant, known medical condition in particular
•any existing conditions that would affect sensitivity to cold (such as
•atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism) or pain (such as
•disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia,
•neuropathy).
•30. Participants indicating pain tests intolerable at screening. Participants
•achieving tolerance at >80% of maximum input intensity for cold pressor and
•electrical pain tests are to be excluded. If pressure pain test tolerance is
•>80% of maximum input intensity they may be enrolled as per PI judgement.

发起方