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Tests treatment safety and results for Healthy Volunteers
Official title Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.
ClinicalTrials.gov ID: NCT06752122
What this study is testing
What is RCS-21 (SAD)?
RCS-21 (SAD) is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function or ECG at...
- 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...
- 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.
- History of allergic reactions to any active or inactive component of the study medication (including medication for bronchoscopy, e.g. salbutamol...
- 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...
See the full eligibility criteria
Who can join
- 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:
- oral
- intravaginal
- transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation:
- oral
- injectable
- implantable
- 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...
- Inform any and all partner(s) of their participation in a clinical drug study and the need to comply with contraception instructions as directed by the investigator.
- Male participants are required to use a condom during treatment and until 30 days after the last administration of study medication.
- Female partners of male participants who have not undergone a vasectomy with the absence of sperm confirmed or a bilateral orchiectomy should consider use of effective methods of contraception during treatment and until...
- Sperm donation is not allowed during treatment and until 30 days after the last administration 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...
- 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.
What rules you out
- 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...
- 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...
- 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.
- 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).
- 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).
- Proneness to orthostatic dysregulation, fainting, or blackouts.
- History or presence of any malignancy except for basalioma.
- Chronic or acute infections or history of an acute infection during the four weeks before the first screening visit.
- 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...
- Positive drug screen (amphetamines, barbiturates, benzodiaze- pines, cannabinoids, cocaine, methadone, methamphetamine, opiates, phencyclidine, or tricyclic antidepressants).
- History of previous administration of any registered or investiga- tional oligonucleotide-based drug.
- History or presence of alcohol or drug abuse.
- 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...
- Positive breath alcohol test.
- Planned donation of oocytes, blood, organs, bone marrow dur- ing the course of the study or within 6 months after the last screening visit.
- 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...
- Blood donation of more than 250 ml within the last 30 days before the first screening visit.
- Anticipated non-availability for study visits/procedures.
- Anticipated lack of willingness or inability to cooperate adequately.
- Vulnerable participants, except WOCBP.
The study team makes the final eligibility decision.
Where it's taking place
- Hanover, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanover, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.