Status and phase
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Study type
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About
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 or multiple doses of RCS-21 for a maximum of 7 days and their health status will be constantly monitored.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Able and willing to give written informed consent.
Male or female aged 18 to 64 years (inclusive).
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:
progestogen-only hormonal contraception associated with inhibition of ovulation:
intrauterine device (IUD)
intrauterine hormone-releasing system (IUS)
bilateral tubal occlusion
vasectomized partner (provided that this partner is the sole sexual partner of the WOCBP participant and that the vasectomized partner has received medical as- sessment of the surgical success)
sexual abstinence (defined as refraining from hetero- sexual intercourse during the entire study period, be- ginning 2 weeks prior to the screening visit) OR
Of non-childbearing potential defined according to the Clinical Trial Facilitation Group (CTFG) document "Recommendations related to contraception and pregnancy testing in clinical trials"
Male participants with female partner(s) of childbearing potential are eligible to participate in the study if they agree to the following during treatment and until 30 days after the last administra- tion of study medication:
Healthy participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead Electrocardiogram (ECG), pulmonary function testing and clinical laboratory tests.
Body Mass Index (BMI) of 18.5 to 31.9 kg/m2 (inclusive).
Ability to inhale in an appropriate manner (e.g. as confirmed in the inhalation training using the PARI eFlow® device with a pla- cebo medication at the screening visit).
Non-smokers (including e-cigarette) or ex-smokers (with less than 10 pack years and stopped smoking for at least 5 years prior to screening visit).
Normal pulmonary function with Forced Expiratory Volume in the first second (FEV1) ≥ 80 % of predicted normal at screening visit. Calculations will be based on the Global Lung Function Initiative (GLI 2012) formula.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
48 participants in 4 patient groups, including a placebo group
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Central trial contact
Johannes Schmidt, Dr.; Christina Beck
Data sourced from clinicaltrials.gov
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