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

NCT06607484 | Terminated Phase 1 DMC

• 2 other identifiers: SR-878-01-0012023-507753-15-00
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Day 1 until Day 85

• Area under the blood concentration-time curve 0-85 days (AUC0-85)

  Day 1 until Day 85

• AUC0-inf

  Day 1 until Day 85

• Maximum concentration (Cmax)

  Day 1 until Day 85

• Reference-adjusted area under the effect curve 0-24 hours (AUEC0-24)

  0-24 hours

Other Outcomes (2)

• Levels of tumour necrosis factor-alpha, and their ratios to baseline after SR-878 administration in Cohorts 1-6

  Day 1 until Day 22

• Development of anti-drug antibodies

  Day 1 - Day 85

Study Arms (2)

SR-878

EXPERIMENTAL

Solution for infusion, administered intravenously once

Drug: SR-878

Placebo

PLACEBO COMPARATOR

Solution for infusion, administered intravenously once

Drug: Placebo

Interventions

SR-878 DRUG

Intravenous infusion

SR-878

Placebo DRUG

Intravenous infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• SciRhom GmbH: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Links

• Link to the website of the sponsor of the clinical trial.

Study Officials

• Jürgen Reeß, Dr.

  SciRhom GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 23, 2024
• Study Start: October 8, 2024
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)