The goal of this clinical trial is to assess the safety, tolerability and pharmacokinetics of ATL-001 (ciclopirox olamine) in healthy volunteers
Participants will receive either the investigational drug (ATL-001) or Placebo (inactive substance). Neither the participant nor the Investigator will know to which of these study drug groups each participant has been assigned. In case of an emergency, however, the Investigator can get this information. After a 30-day Screening period to confirm the eligibility, the prticipants will be treated for 5 days (the treatment period) and followed by 30 days of observation and assessment of treatment outcomes (the follow-up period).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
42
On the morning of Day 1 to Day 5, each participant will receive a single oral dose of ATL-001 or placebo
On the morning of Day 1 to Day 5, each participant will receive a single oral dose of ATL-001 or placebo
Hassman Research Institute, LLC
Berlin, New Jersey, United States
Incidence of adverse events (AEs)
Incidence of adverse events (AEs) and of clinically relevant changes in vital signs values, electrocardiogram (ECG) data, physical examination and laboratory safety data for four different doses of ATL-001
Time frame: 3.5 months, with up to 66 days per participant
Derived pharmacokinetic parameters for ATL-001
Area under the plasma drug concentration
Time frame: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Time curve (AUC(0-last), AUC(0-12), AUC(0-24))
Time frame: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Maximum observed plasma drug concentration (Cmax)
Time frame: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Time to maximum observed plasma drug concentration (tmax)
Time frame: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Apparent terminal half-life (t1/2)
Time frame: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Apparent total body clearance (CL/F)
Time frame: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Apparent volume of distribution (Vz/F)
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Time frame: 6 days per participant