First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects

Inclusion Criteria

• Willing and able to give written informed consent for participation in the trial.
• Healthy males and females of non-childbearing potential aged 18-65 years inclusive.
• Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2
• Clinically normal medical history, physical findings, vital signs, ECG, and laboratory values at the time of screening, as judged by the Investigator
• Women of non-childbearing potential, defined as pre-menopausal females who are sterilized (tubal ligation or permanent bilateral occlusion of fallopian tubes); or females who have undergone hysterectomy or bilateral oophorectomy; or post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with simultaneous detection of follicle stimulating hormone [FSH] ≥ 25 IU/L is confirmatory).

Male subjects must be willing to use condom or be vasectomised 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 (last) dosing with the IMP. Their female partner of child-bearing potential must use highly effective contraceptive methods with a failure rate of 140 mmHg, or

• Diastolic blood pressure 90 mmHg, or
• Pulse 90 bpm
• Prolonged QTcF (>450 ms), PR interval 240 ms, QRS>115 ms, clinically significant cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to C106.
• Regular use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins and minerals within 2 weeks prior to the (first) administration of IMP, at the discretion of the Investigator.
• Planned treatment or treatment with another investigational drug within 3 months prior to Day -1. Subjects consented and screened but not dosed in previous clinical trials are not excluded.
• Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than three times per week is allowed before screening visit.
• Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the IMP.
• History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
• Presence or history of drug abuse, as judged by the Investigator.
• History of, or current use of, anabolic steroids.
• Excessive caffeine consumption defined by a daily intake of >5 cups of caffeine containing beverages.
• Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
• Investigator considers the subject unlikely to comply with trial procedures, restrictions, and requirements.