Safety, Tolerability, PK and PD of EXS21546 (QSC204481)

• Research type

  Research Study

• Full title

  A 3-part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single (Part 1) and Multiple (Part 2) Ascending Oral Doses of EXS21546, and to Evaluate the Relative Bioavailability of a Solid Dose Formulation Compared to a Powder for Oral Suspension (Part 3), in Healthy Male Subjects

• IRAS ID

  289516

• Contact name

  Andrew Payne

• Contact email

  apayne@exscientia.co.uk

• Sponsor organisation

  Exscientia Limited

• Eudract number

  2020-004456-15

• Duration of Study in the UK

  0 years, 7 months, 5 days

• Research summary

  Summary of Research
  The Sponsor is developing the test medicine, EXS21546, for potential use in cancer immunotherapy. Cancer immunotherapy is a type of cancer treatment that uses your own body’s immune system to help fight cancer. The test medicine blocks a specific site present on many cells, blocking this site should allow an increase in the activity of immune cells and thus help to fight the cancer.

  Summary of Results
  Given that this is a Phase I trial, no lay summary of results has been provided for reasons of commercial confidentiality

  The study will try to identify the safety and tolerability of single and multiple ascending doses of the test medicine. It will also try to identify how the test medicine is taken up by the body (pharmacokinetics). It may try to compare the proportion of the test medicine that enters the bloodstream (relative bioavailability) when given in two different forms.

  The study will consist of up to three parts involving healthy male volunteers.

  Sentinel dosing will be used in Parts 1 and 2, meaning two volunteers will be dosed 72-hours before the rest of the group, so that their safety data can be reviewed before dosing the rest. One will receive test medicine and the other will receive the placebo (dummy medicine).

  In Part 1, up to 64 volunteers in up to 8 groups will receive a single dose of the test medicine or placebo. One group will receive two doses (with and without food).

  In Part 2, up to 40 volunteers in up to 5 groups will receive multiple doses of the test medicine or placebo for 14 days, either once or twice daily. One group will also receive an approved medicine to assess any effects on the test medicine.

  Optional Part 3 will enrol 12 volunteers in 1 group to receive a single dose of the test medicine on three occasions.

  Volunteers will return to the clinic 3-7 days after discharge for follow-up safety assessments.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  20/LO/1181

• Date of REC Opinion

  9 Nov 2020

• REC opinion

  Favourable Opinion