Actively Recruiting
Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.
Led by RNATICS GmbH · Updated on 2025-11-20
24
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
Sponsors
R
RNATICS GmbH
Lead Sponsor
L
LungenClinic Grosshansdorf
Collaborating Sponsor
AI-Summary
What this Trial Is 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 dose of RCS-21 and their health status will be constantly monitored.
CONDITIONS
Official Title
Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to give written informed consent
- Male or female aged 18 to 64 years (inclusive)
- Women must not be pregnant or breastfeeding and must use highly effective birth control or practice sexual abstinence during the study
- Male participants with female partners of childbearing potential must use condoms and follow contraception guidelines during and for 30 days after treatment
- Healthy according to medical history, physical exam, vital signs, ECG, lung function, and lab tests
- Body Mass Index (BMI) between 18.5 and 31.9 kg/m2 (inclusive)
- Ability to properly inhale using the PARI eFlow® device
- Non-smokers or ex-smokers with less than 10 pack years who quit at least 5 years ago
- Normal lung function with FEV1 ≥ 80% of predicted normal
You will not qualify if you...
- Clinically relevant abnormal findings in physical exam, labs, vital signs, lung function, or ECG that may risk safety or affect study results
- Past or present diseases affecting study outcome including cardiovascular, malignancy, liver (except Gilbert syndrome), kidney, blood, neurological, endocrine (except stable hypothyroidism), or lung diseases
- Vaccination within 2 weeks before screening
- History or current relevant allergies or drug/food idiosyncrasies
- Allergic reactions to study medication components or bronchoscopy medications
- Blood pressure or pulse outside specified ranges
- Prone to fainting, orthostatic dysregulation, or blackouts
- History or presence of malignancy except basalioma
- Recent or chronic infections within 4 weeks prior to screening
- Positive tests for HIV, hepatitis B or C
- Positive drug screen for listed substances
- Previous use of oligonucleotide-based drugs
- History or presence of alcohol or drug abuse
- Medication use not allowed within specified washout periods
- Positive breath alcohol test
- Planned donation of blood, organs, or bone marrow during or within 6 months after study
- Participation in another clinical study with investigational drug/device within last 3 months (6 months for biologics)
- Blood donation over 250 ml within 30 days before screening
- Anticipated unavailability for study visits or lack of cooperation
- Vulnerable participants except women of childbearing potential
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM)
Hanover, Germany, 30625
Actively Recruiting
Research Team
C
Christina Beck, Dr.
CONTACT
T
Thomas Frischmuth, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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