Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics

A Phase I, Double-Blind, Placebo-controlled, Randomized Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics in Healthy Adults

The SAD design of the study is based on the aim to study safety, tolerability and PK of selected doses of ACD856 in a limited number of healthy volunteers. ACD856 will be administered orally.

Inclusion Criteria:

• Signed and dated informed consent prior to any study-mandated procedure.´
• Willing and able to comply with study requirements.
• Healthy males and healthy women of non-childbearing potential aged ≥18 and <65 years at screening.
• BMI ≥18.0 and ≤30.0 kg/m2 at screening.
• Males and females of non-childbearing potential may be included in the study. Male subjects must be willing to use condom or be vasectomized or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP.
• Clinically acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.

Exclusion Criteria:

• Planned treatment or treatment with another investigational drug within 3 months prior to randomization.
• Positive screen for drugs of abuse or a positive alcohol result at screening or admission to the clinic.
• Clinically relevant findings in laboratory parameters, ECG or vital signs at screening
• Current smokers or users of nicotine products.
• History of alcohol abuse or excessive intake of alcohol.
• Presence or history of drug abuse.
• History of, or current use of, anabolic steroids.
• Excessive caffeine consumption.
• Plasma donation within one month of screening or blood donation prior to screening.