Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MGGM LLC
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Written informed consent.
2. Male or female participant, aged 18 to 65 years, inclusive, at Screening.
3. Body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive, at Screening.
4. Participant understands the study requirements, is willing and able to commit to meet all study requirements, adhere to both approved ADT and study drug regimen, and complete all assessments and all scheduled visits, per Investigator judgment.
You may not be if
1. History or presence of clinically significant abnormality as assessed by physical examination, medical history, 12-lead ECG, vital signs, or laboratory values, which in the opinion of the Investigator would jeopardize the safety of the participant or the validity of the study results, including established QT prolongation, long QT syndrome, torsades de pointes, bradyarrhythmia, ventricular tachycardia, uncompensated heart failure (greater than NYHA Class 1 CHF), uncontrolled hypokalemia, or uncontrolled hypomagnesemia.
2. Any medical, psychiatric condition, or social context that, in the opinion of the Investigator, is likely to unfavourably alter the risk-benefit of participant, to interfere with protocol compliance, or to confound safety or efficacy assessments.
3. Triplicate 12-lead ECG with average QTcF ≥450 msec, and/or a QRS interval ≥120 msec at Screening.
4. Poorly controlled diabetes as defined by a glycosylated hemoglobin (HbA1c) \>8.5% (69 mmol/mol), despite standard care. (Note: re-screening of patients who has failed the screening process due to not meeting this exclusion criterion is allowed after diabetes treatment adjustment and level of glycosylated hemoglobin (HbA1c) back to \<8.5%)
Clareo Health | A Study to Evaluate the Efficacy and Safety of REL-1017 As Adjunctive Treatment of Major Depressive Disorder (MDD)
