Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorRNATICS GmbH
About this trial
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
Qualifiers
Able and willing to give written informed consent.
Male or female aged 18 to 64 years (inclusive).
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
Disqualifiers
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.
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).
Having received any vaccination within the last 2 weeks before the first screening visit.
History or current evidence of clinically relevant allergies or idiosyncrasy to any drug or food.
Trial design
Treatments tested in this trial
- Placebo (SAD)
- RCS-21 (SAD)
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
RNATICS GmbH
Lead sponsor
LungenClinic Grosshansdorf
Collaborator
Source ClinicalTrials.gov