Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.
Trial Parameters
Brief Summary
The goal of this clinical trial is to evaluate the safety and tolerability of RCS-21 in healthy volunteers. Participants will be asked to inhale a single dose of RCS-21 and their health status will be constantly monitored.
Eligibility Criteria
Inclusion Criteria: 1. Able and willing to give written informed consent. 2. Male or female aged 18 to 64 years (inclusive). 3. Women will be considered for inclusion if they are: * Not pregnant, as confirmed by pregnancy test (see assess- ment schedule), and not breastfeeding. AND * WOCBP must use one of the following highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly * according to recommendations by the European Heads of Medicines Agencies - from at least 14 days before the first administration of study medication until 30 days after the last administration of study medication: * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: * oral * intravaginal * transdermal * progestogen-only hormonal contraception associated with inhibition of ovulation: * oral * injectable * implantable * intrauterine device (IUD) * intrauterine hormone-releasin