M5049 Study in Healthy Japanese and Caucasian participants

• Research type

  Research Study

• Full title

  A Phase I, Open-label, Single-dose, Sequential Dose Group Study of Orally Administered M5049 Tablet Formulation in Healthy Japanese and Caucasian Participants to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics.

• IRAS ID

  291492

• Contact name

  Hamzah Malik

• Contact email

  Hamzah.Malik@Labcorp.com

• Sponsor organisation

  Merck Healthcare KGaA

• Eudract number

  2020-005408-20

• Clinicaltrials.gov Identifier

  NCT04880213

• Clinicaltrials.gov Identifier

  Rec Reference , 21/NE/0001

• Duration of Study in the UK

  0 years, 3 months, 15 days

• Research summary

  Summary of Research
  M5049 is a novel orally administered small molecule dual toll-like receptor 7 and 8 (TLR7 and TLR8) antagonist (a class of proteins that play a key role in the non-specific immune system response).

  It specifically inhibits the activation of TLR7/8 (a class of proteins that play a key role in the non-specific immune system response). M5049 may have the potential to inhibit the pathological activity of ribonucleic acid (RNA)-containing immune complexes (a complex of proteins thought to cause the immune system to attack its own cells) and to decrease disease flares and progression in patients suffering from systemic lupus erythematosus (SLE) (a disease that affects multiple organ systems where the person’s immune system reacts to their own cells) and other autoimmune disorders involving TLR7/8. This mechanism of action may also reduce the severe immune response occurring in moderate to severe forms of coronavirus disease 2019 (COVID-19).

  This is a single-center, open-label, single-dose, 3 sequential ascending dose groups Phase I study of orally administered M5049 tablet formulation in healthy Japanese and matched Caucasian participants to evaluate the safety, tolerability, PK (what the body does to the drug) and PD (what the drug does to the body).

  36 participants (18 Japanese and 18 Caucasian) will be enrolled to the study. Each group will contain 6 Japanese and 6 Caucasian subjects, the first group will receive 100mg, the second, 200mg and the third group will receive 300mg of M5048.

  Summary of Results
  Lay Summary not available

• REC name

  North East - York Research Ethics Committee

• REC reference

  21/NE/0001

• Date of REC Opinion

  23 Mar 2021

• REC opinion

  Further Information Favourable Opinion