Careseng 1370 for Healthy Volunteers (NCT03974516) | Clinical Trial Compass
TerminatedPhase 1
Careseng 1370 for Healthy Volunteers
Stopped: This study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19.
Taiwan13 participantsStarted 2020-08-10
Plain-language summary
This study will be performed in healthy volunteers in a conventional 3+3 dose-escalation design.
Who can participate
Age range20 Years – 40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult aged between 20-40 years old (inclusive)
✓. Physically and mentally healthy volunteer as confirmed by an interview, medical history, clinical examination, chest X-rays, and electrocardiogram. Volunteer with non-clinically significant signs or symptoms may be eligible at investigator's discretion.
✓. Body Mass Index (BMI) between 18.5 and 24, inclusive (BMI will be calculated as weight in kilogram \[kg\]/(height in meters)2 \[m2\])
✓. Clinically normal hematology, biochemistry and urinalysis determinations based on investigator's discretion. Volunteer with non-clinically significant signs or symptoms may be eligible at investigator's discretion.
✓. Volunteer is willing and able to comply with study procedures and sign informed consent prior to initiation of any study-mandated procedures.
Exclusion criteria
✕. Volunteer who has a history or evidence of a medical condition that would expose them to a risk of a significant adverse event or interfere with the assessments of safety or pharmacodynamics variables during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, musculoskeletal or hematological disease as determined by the clinical judgment of the investigator
✕. Volunteer has received any other investigational agent within 28 days prior to the first dose of study drug
✕. Volunteer has taken or potentially takes any herbal medication/supplements/medicinal food, prescription medication and/or over-the-counter medication within 2 weeks prior to the first dose of study drug
What they're measuring
1
Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs)