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

ConditionsHealthy VolunteersSafetyTolerabilityPharmacokinetics
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorRNATICS GmbH

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able and willing to give written informed consent.

Male or female aged 18 to 64 years (inclusive).

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Placebo (SAD)

    Drug

    Inhalation of a single dose.

  • RCS-21 (SAD)

    Drug

    Inhalation of a single dose.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Single ascending dose (SAD) - PlaceboPlacebo comparator 1 intervention
Group B: Single ascending dose (SAD) - RCS-21Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

SAD: Frequency and severity of AEs, frequency and severity of ARs.

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

SAD: Cmax (maximum observed plasma concentration)

Time frame
up to 3 days after dosing
2

SAD: tmax (time of Cmax after dosing)

Time frame
up to 3 days after dosing
3

SAD: AUC0-t last (area under the time course of the plasma concentrations up to the last quantifiable plasma concentration)

Time frame
up to 3 days after dosing
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RNATICS GmbH

Lead sponsor

LungenClinic Grosshansdorf

Collaborator

Source ClinicalTrials.gov
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