Healthy VolunteersPhase 1AMIR-21NCT06752122
Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.
A Phase 1 study testing RCS-21 (SAD) and RCS-21 (MD) in people with Healthy Volunteers and Safety, run by RNATICS GmbH at 1 site in Germany.
Trial summary
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 or multiple doses of RCS-21 and their health status will be constantly monitored. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Safety, Tolerability
- What is being tested?
- RCS-21 (SAD) and RCS-21 (MD)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 18 Feb 2025to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to 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:
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- 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 medication:
- 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 30 days after the last administration of study medication.
- 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 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.
Who cannot join
- 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.
- 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).
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- 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 virus antibody (HCV-Ab).
- 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 elimination half-life of the respective drug, or the duration of the pharmacodynamic effect, whatever is longer.
- 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 duration of the pharmacodynamic effect or 10 times the half-life of the respective drug whatever is longer before inclusion in this study.
- Fort Part B (MD), previous dosing in Part A (SAD) of this clinical study.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM)
Hanover, 30625
Jens Hohlfeld, Prof. Dr. med., +49511 - 5350 - 8101, jens.hohlfeld@item.fraunhofer.de
Jens Hohlfeld, Prof. Dr. med.
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Single-ascending and Multiple Doses of RCS-21 in Healthy Volunteers. A Double Blind, Randomized, Placebo Controlled Phase I Study.
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 or multiple doses of RCS-21 and their health status will be constantly monitored.
- Conditions
- Healthy Volunteers, Safety, Tolerability, Pharmacokinetics
- Being tested
- Placebo (SAD), RCS-21 (SAD), Placebo (MD), RCS-21 (MD)
- Keywords
- RCS-21, Phase I, Healthy volunteers, Inhalation, ASO
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (SAD)Drug
Also called 0.9% saline solution
Inhalation of a single dose.
RCS-21 (SAD)Drug
Inhalation of a single dose.
Placebo (MD)Drug
Also called 0.9% saline solution
Inhalation of five doses at 72-hour intervals.
RCS-21 (MD)Drug
Inhalation of five doses at 72-hour intervals.
| Study group | Role | What they receive |
|---|---|---|
| Single ascending dose (SAD) - Placebo | Placebo comparator | In the single ascending dose (SAD) study, healthy volunteers receive a single inhaled dose of placebo, of the same volume as the active treatment. Receives: Drug: Placebo (SAD) |
| Single ascending dose (SAD) - RCS-21 | Experimental | In the single ascending dose (SAD) study, healthy volunteers will receive a single inhaled dose of 0.5 mg/participant in dose group (DG) I, 1.5 mg/participant in DG II, 4.5 mg/participant in DG III and DG IV. Receives: Drug: RCS-21 (SAD) |
| Multiple doses (MD) - Placebo | Placebo comparator | In the multiple dose study, healthy volunteers receive a total of five inhaled doses of placebo, each administered every 72 hours, with each dose matching the volume of the active treatment. Receives: Drug: Placebo (MD) |
| Multiple doses (MD) - RCS-21 | Experimental | In the multiple dose (MD) study, healthy volunteers will receive a total of five inhaled doses of RCS-21, administered at 72-hour intervals. In this DG V, the dose per administration will be 0.5, 1.5, or 4.5 mg, depending on the safety and tolerability data obtained from the single ascending dose (SAD) part. Receives: Drug: RCS-21 (MD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAD: Frequency and severity of AEs, frequency and severity of ARs.
Measured: Through study completion, an average of 9 months
MD: Frequency and severity of AEs, frequency and severity of ARs.
Measured: Through study completion, an average of 6 months
Secondary outcomes (16)
SAD: Cmax (maximum observed plasma concentration)
Measured: up to 72 hours after dosing
SAD: tmax (time of Cmax after dosing)
Measured: up to 72 hours after dosing
SAD: AUC0-t last (area under the time course of the plasma concentrations up to the last quantifiable plasma concentration)
Measured: up to 72 hours after dosing
SAD: AUC0-24 (area under the time course of the plasma concentrations up to 24 h after dosing, i.e. over the course of the intended dosage interval for future repeated dosing)
Measured: up to 24 h after dosing
SAD: AUC0-inf (total area under the time course of the analyte in plasma concentrations extrapolated to infinity)
Measured: up to 72 hours after dosing
SAD: AUC extrapolated (relative extent of extrapolation)
Measured: up to 72 hours after dosing
SAD: t½ (apparent terminal disposition half-life) and lz (apparent terminal elimination rate constant)
Measured: up to 72 hours after dosing
MD: Cmax,1 (maximum observed plasma concentration after the first dose)
Measured: up to 24 hours after the first dose
MD: tmax,1 (time of Cmax after the first dose)
Measured: up to 24 hours after the first dose
MD: AUC0-tlast,1 (area under the time course of the plasma concentrations up to the last quantifiable plasma concentration after the first dose)
Measured: up to 72 hours after the first dose
MD: AUC0-24,1 (area under the time course of the plasma concentrations up to 24 h after the first dose)
Measured: up to 24 hours after the first dose
MD: Ctrough (trough concentration shortly before the next of the repeated doses)
Measured: shortly before the next dose
MD: Cmax,last (maximum observed plasma concentration after the last dose)
Measured: up to 24 hours after the last dose
MD: tmax,last (time of Cmax after the last dose)
Measured: up to 24 hours after the last dose
MD: AUC0-24,last (area under the time course of the plasma concentrations up to 24 h after the last dose)
Measured: up to 24 hours after the last dose
MD: By combining data from the last dose with the data from the first dose: ACRCmax (accumulation ratio for Cmax); ACRAUC (accumulation ratio based on AUC0-24)
Measured: based on PK profiles obtained up to 24 hours after the first and the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start18 Feb 2025
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A double blind, randomized, placebo controlled phase 1 study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RNATICS GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LungenClinic Grosshansdorf
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752122
- Sponsor's protocol ID
- RNATICS-2401
- Other IDs
- 2024-512351-21-00
- Acronym
- AMIR-21
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participants' data that underlie the results reported in a research article will be available to researchers upon request up to 5 years after publication. Interested researchers must submit a methodologically sound proposal to amir-21@rnatics.com. Proposals will be reviewed by the sponsor to ensure that they comply with confidentiality obligations. Data will be made available within 3 months of approval of the proposal in a deidentified format in accordance with applicable privacy laws, data protection standards and consent requirements. Data requestors will need to sign a data access agreement and data will be made available through a dedicated platform.
Publications
Beck C, Ramanujam D, Vaccarello P, Widenmeyer F, Feuerherd M, Cheng CC, Bomhard A, Abikeeva T, Schadler J, Sperhake JP, Graw M, Safi S, Hoffmann H, Staab-Weijnitz CA, Rad R, Protzer U, Frischmuth T, Engelhardt S. Trimannose-coupled antimiR-21 for macrophage-targeted inhalation treatment of acute inflammatory lung damage. Nat Commun. 2023 Jul 28;14(1):4564. doi: 10.1038/s41467-023-40185-1.
PubMed 37507393
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Single-ascending and Multiple Doses of RCS-21 in Healthy Volunteers. A Double Blind, Randomized, Placebo Controlled Phase I Study.
- ClinicalTrials.gov ID
- NCT06752122
- Acronym / sponsor ID
- AMIR-21 / RNATICS-2401
- Conditions
- Healthy Volunteers, Safety, Tolerability, Pharmacokinetics
- Keywords
- RCS-21, Phase I, Healthy volunteers, Inhalation, ASO
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- RNATICS GmbHIndustry (pharma, biotech, devices)
- Collaborators
- LungenClinic Grosshansdorf
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 or multiple doses of RCS-21 and their health status will be constantly monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A double blind, randomized, placebo controlled phase 1 study
| Arm | Type | Receives |
|---|---|---|
| Single ascending dose (SAD) - Placebo | Placebo comparator | Drug: Placebo (SAD)In the single ascending dose (SAD) study, healthy volunteers receive a single inhaled dose of placebo, of the same volume as the active treatment. |
| Single ascending dose (SAD) - RCS-21 | Experimental | Drug: RCS-21 (SAD)In the single ascending dose (SAD) study, healthy volunteers will receive a single inhaled dose of 0.5 mg/participant in dose group (DG) I, 1.5 mg/participant in DG II, 4.5 mg/participant in DG III and DG IV. |
| Multiple doses (MD) - Placebo | Placebo comparator | Drug: Placebo (MD)In the multiple dose study, healthy volunteers receive a total of five inhaled doses of placebo, each administered every 72 hours, with each dose matching the volume of the active treatment. |
| Multiple doses (MD) - RCS-21 | Experimental | Drug: RCS-21 (MD)In the multiple dose (MD) study, healthy volunteers will receive a total of five inhaled doses of RCS-21, administered at 72-hour intervals. In this DG V, the dose per administration will be 0.5, 1.5, or 4.5 mg, depending on the safety and tolerability data obtained from the single ascending dose (SAD) part. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (30 listed)
- 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:
- 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.
Key exclusion criteria (22 listed)
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo (SAD)Also: 0.9% saline solutionInhalation of a single dose. | Drug | Single ascending dose (SAD) - Placebo |
| RCS-21 (SAD)Inhalation of a single dose. | Drug | Single ascending dose (SAD) - RCS-21 |
| Placebo (MD)Also: 0.9% saline solutionInhalation of five doses at 72-hour intervals. | Drug | Multiple doses (MD) - Placebo |
| RCS-21 (MD)Inhalation of five doses at 72-hour intervals. | Drug | Multiple doses (MD) - RCS-21 |
Primary outcome
SAD: Frequency and severity of AEs, frequency and severity of ARs.
Time frame: Through study completion, an average of 9 months
MD: Frequency and severity of AEs, frequency and severity of ARs.
Time frame: Through study completion, an average of 6 months
16 secondary outcomes
SAD: Cmax (maximum observed plasma concentration)
Time frame: up to 72 hours after dosing
SAD: tmax (time of Cmax after dosing)
Time frame: up to 72 hours after dosing
SAD: AUC0-t last (area under the time course of the plasma concentrations up to the last quantifiable plasma concentration)
Time frame: up to 72 hours after dosing
SAD: AUC0-24 (area under the time course of the plasma concentrations up to 24 h after dosing, i.e. over the course of the intended dosage interval for future repeated dosing)
Time frame: up to 24 h after dosing
SAD: AUC0-inf (total area under the time course of the analyte in plasma concentrations extrapolated to infinity)
Time frame: up to 72 hours after dosing
SAD: AUC extrapolated (relative extent of extrapolation)
Time frame: up to 72 hours after dosing
SAD: t½ (apparent terminal disposition half-life) and lz (apparent terminal elimination rate constant)
Time frame: up to 72 hours after dosing
MD: Cmax,1 (maximum observed plasma concentration after the first dose)
Time frame: up to 24 hours after the first dose
MD: tmax,1 (time of Cmax after the first dose)
Time frame: up to 24 hours after the first dose
MD: AUC0-tlast,1 (area under the time course of the plasma concentrations up to the last quantifiable plasma concentration after the first dose)
Time frame: up to 72 hours after the first dose
MD: AUC0-24,1 (area under the time course of the plasma concentrations up to 24 h after the first dose)
Time frame: up to 24 hours after the first dose
MD: Ctrough (trough concentration shortly before the next of the repeated doses)
Time frame: shortly before the next dose
MD: Cmax,last (maximum observed plasma concentration after the last dose)
Time frame: up to 24 hours after the last dose
MD: tmax,last (time of Cmax after the last dose)
Time frame: up to 24 hours after the last dose
MD: AUC0-24,last (area under the time course of the plasma concentrations up to 24 h after the last dose)
Time frame: up to 24 hours after the last dose
MD: By combining data from the last dose with the data from the first dose: ACRCmax (accumulation ratio for Cmax); ACRAUC (accumulation ratio based on AUC0-24)
Time frame: based on PK profiles obtained up to 24 hours after the first and the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 37507393Beck C, Ramanujam D, Vaccarello P, Widenmeyer F, Feuerherd M, Cheng CC, Bomhard A, Abikeeva T, Schadler J, Sperhake JP, Graw M, Safi S, Hoffmann H, Staab-Weijnitz CA, Rad R, Protzer U, Frischmuth T, Engelhardt S. Trimannose-coupled antimiR-21 for macrophage-targeted inhalation treatment of acute inflammatory lung damage. Nat Commun. 2023 Jul 28;14(1):4564. doi: 10.1038/s41467-023-40185-1.
- Individual participant dataSharing planned: Yes. Individual participants' data that underlie the results reported in a research article will be available to researchers upon request up to 5 years after publication. Interested researchers must submit a methodologically sound proposal to amir-21@rnatics.com. Proposals will be reviewed by the sponsor to ensure that they comply with confidentiality obligations. Data will be made available within 3 months of approval of the proposal in a deidentified format in accordance with applicable privacy laws, data protection standards and consent requirements. Data requestors will need to sign a data access agreement and data will be made available through a dedicated platform.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RCS-21 (SAD) and RCS-21 (MD) in people with Healthy Volunteers and Safety, run by RNATICS GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Beck, Dr. (+49 89 200006040, amir-21@rnatics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAD: Frequency and severity of AEs, frequency and severity of ARs. (time frame: Through study completion, an average of 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06752122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.