A Trial to Evaluate the Effect of Delgocitinib on the Heart Rhythm of Healthy People

The trial will be performed in two parts.

• Part 1: Group 1 (dose 1 or placebo) and Group 2 (dose 2 or placebo)
• Part 2: Group 3 (dose 3 or placebo) and Group 4 (dose 4 or placebo)

The doses in Part 2 may be adjusted depending on the results of Part 1.

Participants will be screened within 28 days of their dose. Participants will stay in the clinic from Day -1 to Day 2 (1 day postdose) and will be dosed on Day 1. A follow up phone call will take place 2 week (±2 days) after dosing.

Inclusion criteria

• Body mass index of ≥18.0 and <30.0 kg/m2.
• In good health, as judged by the investigator based on: medical history, physical examination, vital sign assessment, clinical laboratory evaluations .
• ECG without any clinically relevant abnormal findings at both screening and baseline
• No history of additional risk factors for torsades de pointes (for example, heart failure, hypokalaemia, family history of long QT syndrome).
• Female subjects of childbearing potential and male subjects with a female partner of childbearing potential must be willing to use highlly effective methods of contraception.

Exclusion criteria

• Any disorder which is not stable and could:

• Affect the safety of the subject throughout the trial.
• Influence the findings of the trial.
• Impede the subject's ability to complete the trial.
• Use of any medication known to prolong the QT/QTc interval within 3 months or 5 half-lives of the drug, whichever is longer, prior to randomisation.
• Any medications, including St. John's wort, known to chronically alter drug absorption or elimination processes within 30 days prior to dosing.
• Current use of combined hormone contraceptives or combined hormonal replacement therapy.
• Subjects who have smoked (use of any type of tobacco and nicotine containing products) within the last 3 months prior to screening.
• History of chronic alcohol or drug abuse within 12 months prior to screening.
• Receipt of any vaccine approved for SARS-CoV-2 within 4 weeks prior to baseline and/or 2 weeks after dose.
• Receipt of live, attenuated vaccines within 4 weeks prior to baseline.