Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.

Exclusion Criteria

• •1. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function or ECG at screening visit, which, in the opinion of the investigator, may either put the participant at risk because of participation in the study or may influence the results of the study, or the participant's ability to participate in the study.
• •2. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, he- patic disease (asymptomatic Gilbert syndrome is allowed), renal disease, hematological disease, neurological disease, endo- crine disease (stable and asymptomatic hypothyroidism with or without Hormone Replacement Therapy (HRT) is allowed) or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
• •3. Having received any vaccination within the last 2 weeks before the first screening visit.
• •4. History or current evidence of clinically relevant allergies or idiosyncrasy to any drug or food.
• •5. History of allergic reactions to any active or inactive component of the study medication (including medication for bronchoscopy, e.g. salbutamol, lidocaine, midazolam or propofol).
• •6. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm).
• •7. Proneness to orthostatic dysregulation, fainting, or blackouts.
• •8. History or presence of any malignancy except for basalioma.
• •9. Chronic or acute infections or history of an acute infection during the four weeks before the first screening visit.
• •10. Positive results in any of the following virology tests: human im- munodeficiency virus (HIV) antibodies and antigen, Anti-hepati- tis B-core antibody (HBc-Ab), hepatitis B-surface antigen (HBs- Ag) and anti-hepatitis C virus antibody (HCV-Ab).
• •11. Positive drug screen (amphetamines, barbiturates, benzodiaze- pines, cannabinoids, cocaine, methadone, methamphetamine, opiates, phencyclidine, or tricyclic antidepressants).
• •12. History of previous administration of any registered or investiga- tional oligonucleotide-based drug.
• •13. History or presence of alcohol or drug abuse.
• •14. Use of any medication (including over-the-counter medication, herbal products) except allowed concomitant medication within 2 weeks (for biologics: 6 months) before administration of IMP or within \< 10 times the elimination half-life of the respective drug, or the duration of the pharmacodynamic effect, whatever is longer.
• •15. Positive breath alcohol test.
• •16. Planned donation of oocytes, blood, organs, bone marrow dur- ing the course of the study or within 6 months after the last screening visit.
• •17. Participation in another clinical study with an investigational drug or device within the last 3 months or during the course of the study. For biologics, the minimum exclusion period is at least 6 months or the time of duration of the pharmacodynamic effect or 10 times the half-life of the respective drug whatever is longer before inclusion in this study.
• •18. Blood donation of more than 250 ml within the last 30 days before the first screening visit.
• •19. Anticipated non-availability for study visits/procedures.
• •20. Anticipated lack of willingness or inability to cooperate adequately.
• •21. Vulnerable participants, except WOCBP.