Healthy VolunteersPhase 1NCT06607484

Study Investigating the Safety, Tolerability and Blood Concentration of the Substance SR-878

A Phase 1 study testing SR-878 in people with Healthy Volunteers, run by SciRhom GmbH at 1 site in Austria.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: SR-878
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteAustria
Study dates: 8 Oct 2024to 27 Feb 2025
Phase: Phase 1
Are there results?: None posted in the registry

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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or female subjects aged 18 to 40 years inclusive on the day of informed fonsent form (ICF) signature and with a body weight ≥ 45 kg and body mass index (BMI) ≤ 30 kg/m2;
Subjects willing to sign a written informed consent and able to comply with the study protocol for the duration of the study, including the inpatient confinement for about 24 or 32 hours;
Has adequate venous access for blood collection;
In female subjects of childbearing potential, a negative serum pregnancy test at screening;
Females of childbearing potential agreeing to use highly effective methods of contraception for the duration of the study; Males agreeing to use highly effective methods of contraception and not to donate sperm until 90 days after the study drug administration.

Who cannot join

Treatment with an investigational drug within one month or two half-lives prior to screening, whichever is longer;
Abnormal findings in medical history and physical examination that the investigator considers to be a clinically relevant abnormality;
Clinically significant abnormal screening laboratory tests, including but not limited to:
Haemoglobin (HGB) < 120 g/L for males or < 110 g/L for females
White Blood Cells (WBC) > 1.5 upper limit of normal (ULN)
C-reactive Protein (CRP) > 1.5 ULN

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Serum Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) or Alkaline Phosphatase (ALP) > 1.5 ULN
Estimated Glomerular Filtration Rate (eGFR) < 55 mL/min/1.73 m2
Subjects infected with human immunodeficiency virus (HIV), hepatitis B and C viruses (HBV and HCV);
Clinically relevant ECG (12 leads) abnormalities;
Subjects with acute infectious diseases within 2 weeks prior to screening;
History of any autoimmune diseases or any chronic inflammation;
Relevant history of other renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory, chronic infectious, or neurological diseases;
History of anaphylaxis to drugs or major allergic reactions in general, which in the view of the investigator may compromise the safety of the subjects;
Known hypersensitivity to the active substance or to any of the excipients of the investigational medicinal products or auxiliary medicinal products;
Drug abuse, alcohol >1 drink/day, defined according to the Food-based Dietary Guidelines in Europe;
Females who are pregnant, breastfeeding, or planning to become pregnant during the study.

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of Vienna
Vienna, State of Vienna, 1090

Other trials in Austria

About this study

Official title: Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of SR-878 in Healthy Volunteers

SR-878 is a newly developed medicine that aims to treat autoimmune disorders. It inhibits a protein (iRhom2), that regulates enzymes that are involved in the production of cytokines (small proteins that are crucial in controlling the activity of immune system cells). This is the first study in humans, and SR-878 will be administered once to each participant in 6 different doses to establish a safe dosage and investigate, what are potential side effects.

This clinical trial includes six study groups, called cohorts, and each cohort includes 8 participants. In each cohort, 6 participants will receive SR-878 and 2 participants will receive a placebo, a dummy drug with no active ingredients that looks identical. The comparison with placebo will be used to better assess the side effects of SR-878. The dose of SR-878 will be gradually increased between cohorts. Participants in the first cohort will receive the lowest dose, and if this is considered safe 10 days after dosing, the next cohort will be initiated at a higher dose. Participants visit the hospital regularly over the next 12 weeks after receiving SR-878 or placebo. During these visits, medical condition will be checked and blood will be taken.

Participants in the third to sixth cohort will be injected with a product called LPS 24 hours after the infusion of the investigational product, which may stimulate the immune system and cause a temporary inflammatory response in the body. During this time, participants may have mild "flu-like" symptoms. 12 weeks after dose of investigational product, the LPS injection and saline infusion will be repeated.

Read the detailed description

Rationale: SR-878 is a newly developed medicine that aims to treat autoimmune disorders. It works by blocking a protein called iRhom2, which controls the production of small proteins called cytokines. Cytokines are the drivers that keep the inflammatory process ongoing in autoimmune diseases important for regulating the activity of cells in the immune system. This is the first study in humans, and SR-878 will be administered once to each participant in 6 different doses to investigate potential side effects.

Objectives:

To assess the safety and tolerability of a single dose of SR-878;
To select the optimal dose that is safe and tolerable;
To explore any effects of a single dose of SR-878 in the human body;
To investigate the connection between the concentration of SR-878 and potential side effects;
To assess the amount of immune response against SR-878. Trial design: This clinical study will have six treatment groups, so called cohorts, and each cohort will include 8 participants. In each cohort 6 participants will receive SR-878, and 2 participants will receive a placebo, that is a dummy treatment without active ingredients. The comparison with the placebo is used to better assess the side effects of SR-878. The dose of SR-878 will be gradually increased between cohorts.

After the screening period, participants will be randomly assigned to receive SR-878 or placebo. This is a double-blind study, which means neither the participant nor the study staff, including the study doctor, will know which study medication was used.

The study medication will be administered in a 1-hour long infusion. The participants will be requested to stay 24 hours in the hospital after the infusion, and their medical condition will be monitored, and they will undergo several blood draws.

24 hours after the study medication infusion, participants in the 3rd-6th cohorts, will be injected with a product, called lipopolysaccharide (LPS). It has the ability to boost the body's immune response, even without causing an actual infection. LPS might trigger slight flu-like symptoms (i.e. uneasiness, little fever). Participants will be requested to stay an additional 8 hours in the hospital, and they will undergo several blood samplings and their body's reaction will be monitored. In the first 6 hours, they will receive a saline infusion to keep them hydrated, and in case they find the potential symptoms of the provoked inflammation unbearable, the study doctor will provide a medication (paracetamol) to relieve them.

In the following 12 weeks, participants will be requested to return regularly to the hospital, 10 times in total. During these visits, their medical status will be examined, and blood will be collected. For participants in the 3rd-6th cohorts, 12 weeks after their study medication dose, the LPS injection and the saline infusion will be repeated, and they will stay 8 hours again on the site. They will undergo several blood draws, and their medical condition will be monitored. They will also be requested to return to the site on the next day to repeat these assessments.

Interventions:

Participants will receive SR-878 in a 1-hour long infusion once. The dose will depend on the cohort;
Participants in the 3rd-6th cohorts will receive LPS injections twice, in a dose of 2 ng/kg body weight.

Conditions: Healthy Volunteers
Being tested: SR-878, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SR-878Drug
Intravenous infusion
PlaceboDrug
Intravenous infusion

Study groups in NCT06607484
Study group	Role	What they receive
SR-878	Experimental	Solution for infusion, administered intravenously once Receives: Drug: SR-878
Placebo	Placebo comparator	Solution for infusion, administered intravenously once Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of treatment-emergent adverse event (TEAE)
The number and proportion of subjects with TEAE overall and before the LPS challenge will be calculated by cohort and by arm.
Measured: Day 1 to Day 85 in Cohorts 1-2 and Day 1 to 86 in Cohorts 3-6

Secondary outcomes (43)

Terminal half-life (T1/2) of SR-878
Time it takes for the blood plasma concentration of SR-878 to halve its steady-state
Measured: Day 1 until Day 85
Area under the blood concentration-time curve 0-85 days (AUC0-85)
Area under the serum SR-878 concentration versus time curve
Measured: Day 1 until Day 85
AUC0-inf
The area under the plasma SR-878 concentration-time curve extrapolated to infinity
Measured: Day 1 until Day 85
Maximum concentration (Cmax)
Maximum concentration of SR-878 in blood serum
Measured: Day 1 until Day 85
Reference-adjusted area under the effect curve 0-24 hours (AUEC0-24)
The effect of lipopolysaccharide is measured as serum concentrations of tumour necrosis factor-alpha (TNF-alpha).
Measured: 0-24 hours
Maximum effect (Emax) for tumour necrosis factor-alpha (TNF-alpha) after lipopolysaccharide (LPS) challenges
The maximum effect of lipopolysaccharide is measured as the maximum serum concentrations of tumour necrosis factor-alpha (TNF-alpha).
Measured: Day 2-3 and Day 85-86
Safety Measurement Assessment - Adverse Events, including Serious Adverse Events
Reports about Adverse Events, including Serious Adverse Events, are collected, standard terms are recorded
Measured: Day 1 until Day 85 or until day 85 (cohorts 3-6)
Safety Measurement Assessment - Physical Examination
Assessment of the head (external), eyes, ears, nose, throat, lungs, cardiovascular system, abdomen, musculoskeletal system, skin, lymph nodes, central nervous system, and, where appropriate, other body systems. Results of assessments are noted as descriptions. There are no units of measurements. There are no individual parameters, the description provides an overall assessment.
Measured: Day 1 until Day 85 or until day 86 (cohorts 3-6)
Safety Measurement Assessment - Vital signs - Respiratory rate
Breaths per minute
Measured: Screening, Day 1 to day 85 (cohorts 1-2) or to day 86 (cohorts 3-6)
Safety Measurement Assessment - Vital signs - Blood pressure
Pressure or force of blood inside arteries, measured in millimeters of mercury (mmHg).
Measured: Screening, Day 1 to day 85 (cohorts 1-2) or to day 86 (cohorts 3-6)
Safety Measurement Assessment - Vital signs - Heart rate
Frequency of heart beats per minute
Measured: Screening, Day 1 to day 85 (cohorts 1-2) or to day 86 (cohorts 3-6)
Safety Measurement Assessment - Vital signs - Body temperature
Body temperature is measured °C.
Measured: Screening, Day 1, 2, 3, 4, 8, 11, and 86 (cohorts 3-6).
Safety Measurement Assessment - Vital signs - Oxygen saturation
The unit for oxygen saturation is per cent (%).
Measured: Day 2, day 85
Safety Measurement Assessment - Electrocardiogram (ECG) recording
ECG (12-leads) measuement is used to determine the time intervals for periods of the heartbeat called QRS, QT, and QT interval corrected by Frederic's formula (QTcF)
Measured: Screening, Day 1, 2, 3, 11, 85, and 86 (cohorts 3-6).
Safety Measurement Assessment - Urinalysis - Protein concentration
Protein concentration in urine [mg/dL]
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and 86 (cohorts 3-6)
Safety Measurement Assessment - Urinalysis - Blood
Blood concentration is measured as concentration of hemoglobin
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and 86 (cohorts 3-6)
Safety Measurement Assessment - Urinalysis - Glucose concentration
Glucose concentration in urine as mg/dL
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and 86 (cohorts 3-6)
Safety Measurement Assessment - Monitoring of local tolerability
Assessment of degree of local tolerability in terms of erythema and swelling at the injection site immediately and 1.5 hours after the start of IMP and LPS administration.
Measured: Day 1, 2 and 85
Safety Measurement Assessment - Coagulation parameters - INR
INR = international normalised ratio (which has no dimension)
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3-6).
Safety Measurement Assessment - Coagulation parameters - aPTT
aPTT = Activated partial thromboplastin time
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3-6).
Safety Measurement Assessment - Coagulation parameters - Fibrinogen
Concentration of the protein fibrinogen is measured in mg/dL.
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3-6).
Safety Measurement Assessment - Haematology - Haemoglobin
Haemoglobin concentration in blood in g/dL
Measured: Screening, Day 1, 2, 3, 11, 29, 85, and 86 (cohorts 3 - 6)
Safety Measurement Assessment - Haematology - Haematocrit
Percentage of cellular ingredients of blood, measured in per cent (%)
Measured: Screening, Day 1, 2, 3, 11, 29, 85, and 86 (cohorts 3 - 6)
Safety Measurement Assessment - Haematology - Red blood cell count
Number of red blood cells per blood volume
Measured: Screening, Day 1, 2, 3, 11, 29, 85, and 86 (cohorts 3 - 6)
Safety Measurement Assessment - Haematology - White blood cell count
Number of white blood cells per volume blood
Measured: Screening, Day 1, 2, 3, 11, 29, 85, and 86 (cohorts 3 - 6)
Safety Measurement Assessment - Haematology - Platelets
Number of platelets per blood volume
Measured: Screening, Day 1, 2, 3, 11, 29, 85, and 86 (cohorts 3 - 6)
Safety Measurement Assessment - Haematology - Differential blood cell count
Number of neutrophils, eosinophils, basophils, monocytes, lymphocytes per volume blood
Measured: Screening, Day 1, 2, 3, 11, 29, 85, and 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Potassium
Blood serum concentration of potassium in mmol/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Calcium
Blood serum concentration of calcium in mmol/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Chloride
Blood serum concentration of chloride in mmol/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Sodium
Blood serum sodium concentration in mmol/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Uric acid
Blood serum concentration of uric acid in mmol/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Urea
Blood serum concentration of urea in mmol/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Creatinine
Blood serum concentration of creatinine in μmol/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Total bilirubin
Blood serum concentration of total bilirubin in μmol/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Total protein
Blood serum concentration of total protein in g/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Lactate dehydrogenase
Blood serum concentration of lactate dehydrogenase in U/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Glucose
Blood serum concentration of glucose in mmol/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - CRP
Blood serum concentration of CRP = C-reactive Protein in mg/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Alkaline Phosphatase
Blood serum concentration of alkaline phosphatase in U/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Gamma-glutamyl Transferase
Blood serum concentration of gamma-glutamyl transferase in U/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Alanine Aminotransferase
Blood serum concentration of alanine aminotransferase in U/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Aspartate Aminotransferase
Blood serum concentration of aspartate aminotransferase in U/L
Measured: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 202427 Feb 2025

First posted23 Sep 2024
Study start8 Oct 2024
Primary completion27 Feb 2025
Study completion27 Feb 2025

Why it stopped: Sponsor decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06607484
Sponsor's protocol ID: SR-878-01-001
Other IDs: 2023-507753-15-00, 2023
Status last verified: May 2025
First submitted: 4 Sep 2024
Last updated: 3 Jun 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of SR-878 in Healthy Volunteers
ClinicalTrials.gov ID: NCT06607484
Acronym / sponsor ID: SR-878-01-001
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision
Enrolment: 18 participants (actual)
Lead sponsor: SciRhom GmbHIndustry (pharma, biotech, devices)
Study start: 8 Oct 2024 (actual)
Primary completion: 27 Feb 2025 (actual)
Study completion: 27 Feb 2025 (actual)
First posted: 23 Sep 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.

Detailed description

Objectives:

To assess the safety and tolerability of a single dose of SR-878;
To select the optimal dose that is safe and tolerable;
To explore any effects of a single dose of SR-878 in the human body;
To investigate the connection between the concentration of SR-878 and potential side effects;
To assess the amount of immune response against SR-878. Trial design: This clinical study will have six treatment groups, so called cohorts, and each cohort will include 8 participants. In each cohort 6 participants will receive SR-878, and 2 participants will receive a placebo, that is a dummy treatment without active ingredients. The comparison with the placebo is used to better assess the side effects of SR-878. The dose of SR-878 will be gradually increased between cohorts.

Interventions:

Participants will receive SR-878 in a 1-hour long infusion once. The dose will depend on the cohort;
Participants in the 3rd-6th cohorts will receive LPS injections twice, in a dose of 2 ng/kg body weight.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SR-878	Experimental	Drug: SR-878Solution for infusion, administered intravenously once
Placebo	Placebo comparator	Drug: PlaceboSolution for infusion, administered intravenously once

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy male or female subjects aged 18 to 40 years inclusive on the day of informed fonsent form (ICF) signature and with a body weight ≥ 45 kg and body mass index (BMI) ≤ 30 kg/m2;
Subjects willing to sign a written informed consent and able to comply with the study protocol for the duration of the study, including the inpatient confinement for about 24 or 32 hours;
Has adequate venous access for blood collection;
In female subjects of childbearing potential, a negative serum pregnancy test at screening;
Females of childbearing potential agreeing to use highly effective methods of contraception for the duration of the study; Males agreeing to use highly effective methods of contraception and not to donate sperm until 90 days after the study drug administration.

Key exclusion criteria (17 listed)

Treatment with an investigational drug within one month or two half-lives prior to screening, whichever is longer;
Abnormal findings in medical history and physical examination that the investigator considers to be a clinically relevant abnormality;
Clinically significant abnormal screening laboratory tests, including but not limited to:
Subjects infected with human immunodeficiency virus (HIV), hepatitis B and C viruses (HBV and HCV);
Clinically relevant ECG (12 leads) abnormalities;

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
SR-878Intravenous infusion	Drug	SR-878
PlaceboIntravenous infusion	Drug	Placebo

Primary outcome

Occurrence of treatment-emergent adverse event (TEAE)
Time frame: Day 1 to Day 85 in Cohorts 1-2 and Day 1 to 86 in Cohorts 3-6
The number and proportion of subjects with TEAE overall and before the LPS challenge will be calculated by cohort and by arm.

43 secondary outcomes

Terminal half-life (T1/2) of SR-878
Time frame: Day 1 until Day 85
Area under the blood concentration-time curve 0-85 days (AUC0-85)
Time frame: Day 1 until Day 85
AUC0-inf
Time frame: Day 1 until Day 85
Maximum concentration (Cmax)
Time frame: Day 1 until Day 85
Reference-adjusted area under the effect curve 0-24 hours (AUEC0-24)
Time frame: 0-24 hours
Maximum effect (Emax) for tumour necrosis factor-alpha (TNF-alpha) after lipopolysaccharide (LPS) challenges
Time frame: Day 2-3 and Day 85-86
Safety Measurement Assessment - Adverse Events, including Serious Adverse Events
Time frame: Day 1 until Day 85 or until day 85 (cohorts 3-6)
Safety Measurement Assessment - Physical Examination
Time frame: Day 1 until Day 85 or until day 86 (cohorts 3-6)
Safety Measurement Assessment - Vital signs - Respiratory rate
Time frame: Screening, Day 1 to day 85 (cohorts 1-2) or to day 86 (cohorts 3-6)
Safety Measurement Assessment - Vital signs - Blood pressure
Time frame: Screening, Day 1 to day 85 (cohorts 1-2) or to day 86 (cohorts 3-6)
Safety Measurement Assessment - Vital signs - Heart rate
Time frame: Screening, Day 1 to day 85 (cohorts 1-2) or to day 86 (cohorts 3-6)
Safety Measurement Assessment - Vital signs - Body temperature
Time frame: Screening, Day 1, 2, 3, 4, 8, 11, and 86 (cohorts 3-6).
Safety Measurement Assessment - Vital signs - Oxygen saturation
Time frame: Day 2, day 85
Safety Measurement Assessment - Electrocardiogram (ECG) recording
Time frame: Screening, Day 1, 2, 3, 11, 85, and 86 (cohorts 3-6).
Safety Measurement Assessment - Urinalysis - Protein concentration
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and 86 (cohorts 3-6)
Safety Measurement Assessment - Urinalysis - Blood
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and 86 (cohorts 3-6)
Safety Measurement Assessment - Urinalysis - Glucose concentration
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and 86 (cohorts 3-6)
Safety Measurement Assessment - Monitoring of local tolerability
Time frame: Day 1, 2 and 85
Safety Measurement Assessment - Coagulation parameters - INR
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3-6).
Safety Measurement Assessment - Coagulation parameters - aPTT
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3-6).
Safety Measurement Assessment - Coagulation parameters - Fibrinogen
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3-6).
Safety Measurement Assessment - Haematology - Haemoglobin
Time frame: Screening, Day 1, 2, 3, 11, 29, 85, and 86 (cohorts 3 - 6)
Safety Measurement Assessment - Haematology - Haematocrit
Time frame: Screening, Day 1, 2, 3, 11, 29, 85, and 86 (cohorts 3 - 6)
Safety Measurement Assessment - Haematology - Red blood cell count
Time frame: Screening, Day 1, 2, 3, 11, 29, 85, and 86 (cohorts 3 - 6)
Safety Measurement Assessment - Haematology - White blood cell count
Time frame: Screening, Day 1, 2, 3, 11, 29, 85, and 86 (cohorts 3 - 6)
Safety Measurement Assessment - Haematology - Platelets
Time frame: Screening, Day 1, 2, 3, 11, 29, 85, and 86 (cohorts 3 - 6)
Safety Measurement Assessment - Haematology - Differential blood cell count
Time frame: Screening, Day 1, 2, 3, 11, 29, 85, and 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Potassium
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Calcium
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Chloride
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Sodium
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Uric acid
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Urea
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Creatinine
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Total bilirubin
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Total protein
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Lactate dehydrogenase
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Glucose
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - CRP
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)
Safety Measurement Assessment - Blood chemistry - Alkaline Phosphatase
Time frame: Screening, Day 1, 2, 3, 11, 29, 85 and day 86 (cohorts 3 - 6)

Results and safety

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
Link to the website of the sponsor of the clinical trial.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
Screening Protocol
Pain

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. This study is not recruiting at the moment.

Jürgen Reeß, Dr. study chair

SciRhom GmbH

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 SR-878 in people with Healthy Volunteers, run by SciRhom GmbH at 1 site in Austria.

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 5 inclusion and 17 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: stopped early, as of the sponsor's last update on 3 Jun 2025. 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 Austria. 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?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of treatment-emergent adverse event (TEAE) (time frame: Day 1 to Day 85 in Cohorts 1-2 and Day 1 to 86 in Cohorts 3-6). 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 NCT06607484.

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 3 Jun 2025.