Pharmacokinetics, Tolerability and Safety of NEX-18a

Inclusion Criteria

• •1. Provision of written informed consent prior to any study specific procedures.
• •2. Female and male patients ≥ 18 years of age.
• •3. Body Mass Index (BMI) \> 19 and \< 30 kg/m2 BSA at screening.
• •4. Treatment with azacitidine corresponding to 100 mg/m2 BSA x 5 per treatment cycle for at least six cycles for:
• •1. intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS)
• •2. chronic myelomonocytic leukemia (CMML) with 10-29 % marrow blasts
• •3. acute myeloid leukemia (AML) according to World Health Organization (WHO) classification
• •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• •6. Recovery of Hematology and Clin. Chemistry assessment according to clinical praxis at the start of the last azacitidine treatment cycle before the screening visit.
• •7. Female subject must be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy or bilateral oophorectomy; or as post-menopausal females defined as 12 months' amenorrhoea \[in questionable cases a blood sample with simultaneous follicle stimulation hormone 25-140 IE/L and estradiol \< 200 pmol/L is confirmatory\])
• •8. Male patients must agree to use an adequate method of contraception. Male patients who are sexually active must use, with their partner, a condom AND one of the following methods of highly effective contraception from the time of IMP administration until 90 days after the last dose of IMP.
• •1. oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable or implanted hormonal contraceptives
• •2. intrauterine device
• •3. intrauterine system (for example progestin-releasing coil)
• •4. vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
• •5. bilateral tubal occlusion or hysterectomy
• •9. Willingness and ability to comply with study procedures, visit schedules, study restrictions, and requirements.