The study was planned to consist of 24 healthy subjects in 3 dosing cohorts receiving a continuous i.v. infusion of KAND567 or placebo for 6 h (6 subjects on active and 2 subjects on placebo per cohort), with the option of two additional cohorts of the same size and group composition.
The 3 planned dose levels of KAND567 were based on preliminary data from previous i.v. infusions and were chosen to obtain approximate Css levels of 0.5, 1.0 and 2.0 μM. The dose levels were 33.8 mg/6 h (cohort 1), 67 mg/6 h (cohort 2), or 134 mg/6 h (cohort 3). Each cohort of participants was planned to consist of 8 subjects (2 on placebo and 6 on active drug), i.e. a total of 24 subjects. A sentinel approach was used for all three cohorts, starting dosing with two subjects (one on active drug, one on placebo). If safe and tolerable, an additional two or three subjects will be administered. If safe and tolerable, the remaining three or four subjects of the cohort were dosed. There was an evaluation of safety and tolerability from the previous cohort prior to proceeding to the next cohort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
Clinical Research Services Turku (CRST)
Turku, Finland
Safety and tolerability after continuous infusion of KAND567, as measured by adverse events (AEs)
Measured by the occurrence of AEs and serious adverse events (SAEs)
Time frame: From the first IMP administration (Day 1) until the last follow-up visit (Day 30)
Safety and tolerability after continuous infusion of KAND567, as measured by vital signs
Measured by the occurrence of clinically abnormal vital signs
Time frame: From the first IMP administration (Day 1) until the last follow-up visit (Day 30)
Safety and tolerability after continuous infusion of KAND567, as measured by ECG
Measured by the occurrence of clinically abnormal electrocardiography (ECG)
Time frame: From the first IMP administration (Day 1) until the last follow-up visit (Day 30)
Safety and tolerability after continuous infusion of KAND567, as measured by lab safety tests
Measured by the occurrence of clinically abnormal lab test results (routine clinical chemistry, haematology, and urinalysis)
Time frame: From the first IMP administration (Day 1) until the last follow-up visit (Day 30)
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by Css
Measured by plasma drug concentration at steady state (Css)
Time frame: From the first IMP administration (Day 1) until Day 2
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by AUC
Measured by the area under the plasma concentration-time curve (AUC)
Time frame: From the first IMP administration (Day 1) until Day 2
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by t1/2z
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Measured by terminal half-life (t1/2z)
Time frame: From the first IMP administration (Day 1) until Day 2
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by Vss
Measured by the apparent volume of distribution at steady state (Vss)
Time frame: From the first IMP administration (Day 1) until Day 2
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by CL
Measured by the systemic clearance (CL)
Time frame: From the first IMP administration (Day 1) until Day 2