NCT06030375

Safety, Tolerability and Pharmacokinetics After Continuous Infusion of KAND567

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Novakand Pharma AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	KAND567	Continuous intravenous infusion for 6 hours
OTHER	Placebo	Continuous intravenous infusion for 6 hours

Timeline

• Start date: 2020-02-17
• Primary completion: 2020-04-27
• Completion: 2020-04-27
• First posted: 2023-09-11
• Last updated: 2023-09-11

Locations

1 site across 1 country: Finland