Status:
TERMINATED
Study Investigating the Safety, Tolerability and Blood Concentration of the Substance SR-878
Lead Sponsor:
SciRhom GmbH
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
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 th...
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....
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06607484
Start Date
October 8 2024
End Date
February 27 2025
Last Update
June 3 2025
Active Locations (1)
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1
Medical University of Vienna
Vienna, Vienna, Austria, 1090