Status and phase
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Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of KW-6356 in healthy volunteers
Full description
The study will have 3 parts:
Enrollment
Sex
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Volunteers
Inclusion criteria
Individuals who provided freely-given written consent for participating in this study
Men aged 20 ≥ and < 45 at the time of informed consent;
Individuals with BMI ≥ 18.5 and < 30.0
Individuals with screening results of; resting pulse rate: 40 to 100 bpm, systolic blood pressure: 91 to 140 mmHg, diastolic blood pressure: 40 to 90 mmHg
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
48 participants in 7 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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