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Safety, Tolerability and Pharmacokinetics After Continuous Infusion of KAND567

Healthy Clinical Trial

Official title:
Safety, Tolerability and Pharmacokinetics After Continuous Infusion of KAND567. A Single-centre, Placebo-controlled, Randomised, Double-blind Study in Healthy Subjects

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06030375
Study type Interventional
Source Kancera AB
Contact
Status Completed
Phase Phase 1
Start date February 17, 2020
Completion date April 27, 2020
View Details
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