Investigating the safety and tolerability of SR-878 in healthy volunteers

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

This study is testing a new medication called SR-878 to see if it's safe and how well it works in healthy volunteers before it’s used for treating autoimmune disorders.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: SciRhom GmbH (Industry-sponsored)
• Locations: 1 site (Vienna)
• Trial ID: NCT06607484 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates SR-878, a new medication designed to treat autoimmune disorders by inhibiting the protein iRhom2, which regulates cytokine production. The study involves healthy volunteers who will receive a single dose of SR-878 in one of six cohorts, with each cohort consisting of 8 participants—6 receiving the drug and 2 receiving a placebo. The primary objectives are to assess the safety and tolerability of SR-878, determine the optimal dosage, and explore any effects on the human body. The trial is double-blind, ensuring that neither participants nor study staff know who receives the active drug versus the placebo.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 18 to 40 with a BMI of 30 or less.

Not a fit: Patients with existing autoimmune disorders or those who have recently participated in other investigational drug studies may not benefit from this trial.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients with autoimmune disorders.

How similar studies have performed: While this is the first study of SR-878 in humans, similar approaches targeting cytokine regulation have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

1. 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;
2. 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;
3. Has adequate venous access for blood collection;
4. In female subjects of childbearing potential, a negative serum pregnancy test at screening;
5. 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 Criteria:

1. Treatment with an investigational drug within one month or two half-lives prior to screening, whichever is longer;
2. Abnormal findings in medical history and physical examination that the investigator considers to be a clinically relevant abnormality;
3. 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
4. Subjects infected with human immunodeficiency virus (HIV), hepatitis B and C viruses (HBV and HCV);
5. Clinically relevant ECG (12 leads) abnormalities;
6. Subjects with acute infectious diseases within 2 weeks prior to screening;
7. History of any autoimmune diseases or any chronic inflammation;
8. Relevant history of other renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory, chronic infectious, or neurological diseases;
9. 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;
10. Known hypersensitivity to the active substance or to any of the excipients of the investigational medicinal products or auxiliary medicinal products;
11. Drug abuse, alcohol \>1 drink/day, defined according to the Food-based Dietary Guidelines in Europe;
12. Females who are pregnant, breastfeeding, or planning to become pregnant during the study.

Where this trial is running

Vienna

• Medical University of Vienna — Vienna, Austria (Recruiting)

Study contacts

• Study coordinator: Jürgen Reeß, Dr.

Conditions Healthy Volunteers