CTH120 First-in-Human Study: Single and Multiple Ascending Doses and Potential Food Interaction

Safety and Tolerability of CTH120, First-in-human Phase I Study Encompassing Three Parts: Single and Multiple Ascending Doses and Potential Food Interaction

The purpose of this First-in-Human Phase I study is to investigate the safety, tolerability and pharmacokinetics of CTH120 in adult healthy volunteers.

This trial is divided in three parts: FIH-CTH120-SAD (Single Ascending Doses), FIH-CTH120-MAD (Multiple Ascending Doses) and FIH-CTH120-FI (Food Interaction). FIH-CTH120-SAD will start first. The start of FIH-CTH120-MAD will await the results of at least three cohorts from the FIH-CTH120-SAD study before initiated. The starting dose of the FIH-CTH120-MAD will have been shown to be well tolerated in FIH-CTH120-SAD. FIH-CTH120-FI will be the last to start.

Inclusion Criteria:

• Healthy male subjects: As the effect of the study drug on sperm is still unknown, male subjects should refrain from donating sperm or plan a pregnancy with their partner throughout the study and after 90 days after the trial and must report immediately to the study doctor if its partner becomes pregnant during the study and during 90 days after the study. The male subject will have to use double- barrier contraceptive methods: male condoms and spermicide.
• Healthy female subjects of non-child-bearing potential: females may be accepted if they are documented to be surgically sterile i.e., hysterectomy, tubal ligation or post-menopausal with a negative pregnancy test.
• Age ≥ 18 and ≤ 55 years.
• Weight ≥ 50 kg and ≤ 100 kg.
• Body mass index (BMI) ≥ 18 and ≤ 30.
• Negative serum pregnancy test (women only).
• Non-smoking.
• No history of or ongoing clinically relevant diseases or conditions.
• No clinically relevant findings in physical examination, vital signs (blood pressure, heart rate and body temperature), ECG and safety laboratory parameters that should be within normal ranges or considered as non-clinically relevant by the investigator.
• Able/willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine containing items during the duration of the trial including when out of CRU.
• Able to read Spanish or Catalan and adhere to study requirements.
• Not under any administrative or legal supervision.
• Signed informed consent prior to any study-mandated procedure.

Exclusion Criteria:

• Women of child-bearing potential.
• Life-time substance use disorders (SUD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
• Recreational use of drugs of abuse within the last month prior to study drug administration (verified by hair testing).
• Positive blood or urine test for drugs of abuse or alcohol breath test prior to study drug administration.
• Life-time history of mental diseases.
• History of anxiety or depression not completely recovered within 12 months prior to study drug administration, as assessed by the Dual Diagnosis Screening Interview (DDSI).
• Clinically relevant cognitive impairment preventing the administration of the psychometric tests.
• Any other clinically relevant disease or condition that in the judgment of the investigator might interfere with the subject's ability to comply with study procedures or requirements and/or bias the interpretation of the study results and/or jeopardize the subject's safety.
• Ongoing gastrointestinal diseases or history of gastrointestinal surgery affecting absorption.
• Subjects with a clinically significant disease within one month prior to study drug administration.
• Any clinically relevant findings in physical examination, vital signs, ECG and safety laboratory parameters.
• A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms).
• A history of additional risk factors for TdP (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome).
• The use of concomitant medications that prolong the QT/QTc interval.
• Positive hepatitis or HIV test.
• Known hypersensitivity to drug or drug excipients.
• Use of drugs known to induce or inhibit hepatic drug metabolism within one month prior to study administration or during the study and use of citrus juice during the study.
• Any prescription or over-the-counter (OTC) product including herbal, homeopathic, vitamins, minerals and nutritional supplements within 2 weeks (or more, considering the elimination half-life of the product) prior to study drug administration.
• Donation of blood or plasma within one month prior to study drug administration or transfusion of blood or plasma for medical/surgical reasons or intention to donate blood or plasma within one month after study drug administration.
• History of inadequate venous access and/or experience of difficulty donating blood.
• Not able/not willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine containing items when out of CRU.
• Subject included in a clinical study within 3 months prior to study drug administration.
• Subject already included in other parts of this study.