The purpose of this Phase IIa study is to evaluate the safety, tolerability, and effectiveness of CTH120 in adult males with Fragile X syndrome.
Age range
18 Years – 45 Years
Sex
MALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Treatment-emergent adverse events (TEAEs).
Timeframe: From Day 1 to End-of-study: EOS will be on Day 56 (±2 days).
Treatment-emergent potentially clinically significant abnormalities (PSCAs) in blood pressure (mmHg).
Timeframe: From Day 1 to End-of-study (EOS): on Day 56 (±2 days).
Treatment-emergent potentially clinically significant abnormalities (PSCAs) in pulse rate (bpm).
Timeframe: From Day 1 to End-of-study (EOS): on Day 56 (±2 days).
Treatment-emergent potentially clinically significant abnormalities (PSCAs) in body temperature (ºC).
Timeframe: From Day 1 to End-of-study (EOS): on Day 56 (±2 days).
Treatment-emergent potentially clinically significant abnormalities (PSCAs) in electrocardiogram (ECG) values: heart rate (bpm).
Timeframe: From Day 1 to End-of-study (EOS): on Day 56 (±2 days).
Treatment-emergent potentially clinically significant abnormalities (PSCAs) in electrocardiogram (ECG) values: rhythm.
Timeframe: From Day 1 to End-of-study (EOS): on Day 56 (±2 days).
Treatment-emergent potentially clinically significant abnormalities (PSCAs) in electrocardiogram (ECG) values: PQ/PR interval (ms).
Timeframe: From Day 1 to End-of-study (EOS): on Day 56 (±2 days).
Treatment-emergent potentially clinically significant abnormalities (PSCAs) in electrocardiogram (ECG) values: QRS duration (ms).
Timeframe: From Day 1 to End-of-study (EOS): on Day 56 (±2 days).
Treatment-emergent potentially clinically significant abnormalities (PSCAs) in electrocardiogram (ECG) values: QT (ms).
Timeframe: From Day 1 to End-of-study (EOS): on Day 56 (±2 days).
Treatment-emergent potentially clinically significant abnormalities (PSCAs) in electrocardiogram (ECG) values: QTcF (ms).
Timeframe: From Day 1 to End-of-study (EOS): on Day 56 (±2 days).
Treatment-emergent potentially clinically significant abnormalities (PSCAs) in safety laboratory parameters: haematology.
Timeframe: Screening visit (From Day -28 to Day -1), on Day 15, on Day 28, on Day 42 and Day 56 (± 2 days) (End-of-study (EOS)).
Treatment-emergent potentially clinically significant abnormalities (PSCAs) in safety laboratory parameters: serum chemistry.
Timeframe: Screening visit (From Day -28 to Day -1), on Day 15, on Day 28, on Day 42 and Day 56 (± 2 days) (End-of-study (EOS)).
Treatment-emergent potentially clinically significant abnormalities (PSCAs) in safety laboratory parameters: coagulation.
Timeframe: Screening visit (From Day -28 to Day -1), on Day 15, on Day 28, on Day 42 and Day 56 (± 2 days) (End-of-study (EOS)).
Treatment-emergent potentially clinically significant abnormalities (PSCAs) in safety laboratory parameters: urinalysis.
Timeframe: Screening visit (from Day -28 to Day -1).
Treatment-emergent potentially clinically significant abnormalities (PSCAs) in safety laboratory parameters: viral serology and detection.
Timeframe: Screening visit (from day -28 to Day -1).