A first-in-human, single-centre, placebo-controlled, randomized, double-blind study in healthy subjects to evaluate safety, tolerability, pharmacokinetics and food effect after oral single and multiple ascending dosing of KAND567

A first-in-human, single-centre, placebo-controlled, randomized, double-blind study in healthy subjects to evaluate safety, tolerability, pharmacokinetics and food effect after oral single and multiple ascending dosing of KAND567 - KAN0001 (CS0276)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44294

Enrollment

Registered

2018-01-09

Start date

2017-05-22

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS Multiple sclerosis

Interventions

The study will start with a screening. At the screening a physical examination will take place and a few other standard medical assessments will be performed (ECG,vital signs). Furthermore a blood a

First-in-human

healthy subjects

Pharmacokinetics

Safety

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Healthy male and female

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities at medical research

Design outcomes

Primary

Measure	Time frame
The safety endpoint parameters are frequency and severity of adverse events, vital signs, electrocardiography (ECG), safety laboratory tests and urinalysis.	—

Secondary

Measure	Time frame
The pharmacokinetic parameters.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)