RecruitingPHASE1INTERVENTIONAL

Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.

This research study, called RCS-21, is looking for healthy volunteers aged 18 to 64 to help us understand a new investigational inhaled medicine. The main goal is to find out if RCS-21 is safe and well-tolerated when given as a single dose. We also want to learn how the medicine behaves in the body. If you join, you'll inhale one dose of RCS-21 (or a dummy treatment called a placebo) and your health will be closely watched by our medical team. This type of early study is crucial to help us learn more about new medicines before they can be tested in people who are unwell.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

RNATICS GmbH

Enrolment target

Start

18 Feb 2025

Estimated completion

01 Aug 2026

Healthy Volunteers Safety Tolerability Pharmacokinetics

What is this study about?

This study is a very early stage of testing for a new potential medicine called RCS-21. Think of it like the first step in introducing a new car to the world – we first check how it runs under controlled conditions before putting it out on the general road. In this case, we're giving a single dose of RCS-21 as an inhaled treatment, or a placebo (a dummy treatment with no active medicine), to healthy people. This helps us see if the new medicine is safe and if there are any immediate side effects or reactions.

The main aim is to understand how your body reacts to RCS-21. This includes looking at things like how much of the medicine gets into your system, how long it stays there, and how your body processes it. This information, called 'pharmacokinetics', is really important for scientists to decide the right dose and how often it might need to be taken in future studies.

Studies like this, called Phase 1 trials, are vital for developing new medicines. By testing in healthy volunteers first, we can make sure a medicine is broadly safe before moving on to test it in people who might benefit from it for a specific illness. Your participation helps pave the way for potential new treatments in the future, even though this study doesn't aim to treat any existing health condition you might have.

Key takeaways

This is an early study testing a new inhaled medicine (RCS-21) in healthy people.
The main goals are to check safety, how well it's tolerated, and how it acts in the body.
Participants will receive a single dose of RCS-21 or a placebo.
Your health will be closely monitored throughout your participation.
Participation helps future medical research and potential new treatments.
You can withdraw from the study at any time without fuss.

Who may be eligible?

To join this study, you need to be a healthy man or woman between 18 and 64 years old. You must be happy to read and sign a consent form, which explains everything about the study in detail.

If you are a woman, you cannot be pregnant or breastfeeding. If you could potentially become pregnant, you need to agree to use a highly effective method of contraception (birth control) that has a very low chance of failing, and continue using it for at least 30 days after your last dose of the study medicine. This is to make sure you don't become pregnant during the study. If you have had your fallopian tubes tied (bilateral tubal occlusion), have an IUD or IUS fitted, or are sure you won't have sex with men for the whole study period and for two weeks before, you could also be eligible. If you've been through menopause or had a hysterectomy your eligibility will also be considered.

If you are a man and your partner could potentially become pregnant, you must agree to tell them about your involvement in the study and use effective contraception during the study and for 30 days after your last dose of the study medicine. This is to ensure the safety of any potential future child.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 64 years old?
Are you generally in good health?
If you are a woman, are you not pregnant or breastfeeding?
If you are a woman who could become pregnant, are you willing to use highly effective contraception?
If you are a man, are you willing to inform your partner and use contraception if they could become pregnant?
Are you willing to give your written permission to join the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to make sure you're suitable. Once you're confirmed as eligible, you will come to our study clinic and be given a single dose of RCS-21 or a placebo (a dummy treatment). You will inhale this medicine. After taking the dose, your health will be regularly checked by our medical team. This will involve various assessments like blood tests, urine tests, and checks of your vital signs (like heart rate and blood pressure). You will be monitored closely for a period of time to see how you react to the medicine and how it moves through your body. The total duration of your participation in the study, including all visits and follow-ups, will be clearly explained to you.

Potential risks and benefits

Taking part in any clinical study involves potential risks and benefits. A potential benefit of this study is contributing to medical science and helping to develop new treatments that could benefit others in the future, though there is no direct personal medical benefit to you as a healthy volunteer. Potential risks include possible side effects from the study medicine, even though it's given in a controlled environment and you'll be closely monitored. There are also risks associated with the required tests, like slight discomfort from blood draws. You will be given a detailed explanation of all known or potential risks before you decide to join. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM)
Verified postcode
Hanover, Germany· Recruiting

Common questions

What is RCS-21?

RCS-21 is a new medicine we are testing for the very first time in people. We don't know yet what it might be used for, as this study is just about checking its safety and how it works in the body.

What is a 'healthy volunteer'?

A healthy volunteer is someone who does not have any significant ongoing illnesses and is generally in good health. We check this with various medical tests during the screening process.

Will I definitely get the new medicine?

No, you might receive the new medicine RCS-21, or you might receive a placebo, which looks identical but contains no active medicine. This helps us accurately compare the effects of the new medicine.

What is 'pharmacokinetics'?

This is a fancy word for how the medicine travels through your body – how it's absorbed, distributed, broken down, and removed. It helps us figure out the right dose to use in future studies.

Will I be paid for taking part?

The study will clearly explain if any payment or compensation is offered for your time and inconvenience. This will be discussed during the consent process.

How to find out more

Christina Beck, Dr.

amir-21@rnatics.com +49 89 200006040 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.