An Open-label, Single-center, 4-week Phase I Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of GRT6019 in Healthy Male Participants
The purpose of this trial is to assess the safety, tolerability, and PK of 3 doses of GRT6019 in healthy male participants. This Phase I trial will be a multiple dose trial in healthy male participants with administration of GRT6019 in 3 cohorts. For each participant, the trial consists of a Screening Period of up to 28 days, a 4 week Treatment Period (including a 2-week clinic stay and 2 weeks in an outpatient setting), and a 5 week Follow-up Period.
• Participant must be male, 18 to 55 years of age (inclusive) at the time of signing the informed consent form and affiliated to the social security system.
• Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Participant must sign the informed consent form before any trial-related assessments.
• The participant is in good health as determined by the medical history, physical examination, 12-lead ECG, vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure \[BP\]), body temperature, and clinical laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis) without clinically relevant (per investigator judgement) deviations from reference ranges unless further specified in the exclusion criteria. The population of this clinical trial is healthy volunteer participants.