Phase 1 SAD/MAD Study of AF-130 in Healthy Subjects (QCL117572)

• Research type

  Research Study

• Full title

  A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of AF-130 in Healthy Subjects

• IRAS ID

  188511

• Contact name

  Michael Kitt

• Contact email

  Michael.Kitt@afferentpharma.com

• Eudract number

  2015-003571-30

• Clinicaltrials.gov Identifier

  NCT02652936

• Duration of Study in the UK

  0 years, 5 months, 14 days

• Research summary

  The Sponsor is developing the study drug, AF-130, for the potential treatment of hypertension.

  This two-part study will look at the safety, tolerability and pharmacokinetics (what the body does to the drug) of different formulations and dose levels of AF-130, compared to a placebo (dummy drug). The effect of the drug on taste may also be assessed.

  Part 1 will look at the drug when given as a single ascending dose, and Part 2 will look at the drug when given as a multiple ascending dose to healthy volunteers.

• REC name

  Wales REC 1

• REC reference

  15/WA/0346

• Date of REC Opinion

  23 Oct 2015

• REC opinion

  Further Information Favourable Opinion