Single-Ascending Dose Study in Chinese adults to evaluate ABT-333

• Research type

  Research Study

• Full title

  A Blinded, Randomized, Placebo-Controlled Phase 1 Study in Healthy Chinese Adults to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Doses of ABT-333

• IRAS ID

  56655

• Contact name

  Daryl Bendel

• Sponsor organisation

  Abbott Laboratories, Inc.

• Eudract number

  2010-020777-17

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The primary objective of this study is to assess the safety, tolerability, and pharmacokinetics of ABT-333 in healthy Han Chinese adults in single-ascending doses for the treatment of Hepatitis C infection. This is a Phase 1, single center, single-ascending dose, blinded, placebo-controlled, non-fasting study. The study will be conducted in 3 sequential groups, 400, 800, and 1200 mg, in which escalating doses of ABT-333 will be assessed. Up to 24 first generation Han Chinese adult male and female subjects in good health will be selected to participate in the study. Safety, tolerability, and pharmacokinetics will be assessed in each group prior to dose escalation. Subjects will be randomly assigned to receive single oral doses of ABT-333 or matching placebo in a dose escalation fashion. There will be 3 groups and each group will consist of 8 healthy subjects. 6 subjects will be randomly assigned to receive 1 oral dose of ABT-333 and 2 subjects will be randomly assigned to receive matching placebo. The subjects will be admitted to the unit on Day -2 and remain in the unit until Day 5 and they will return for follow-up on Day 10. In the event of that a subject withdraws or is discontinued from the study prior to Day5, he/she will need to attend the Discontinuation Visit within 7 days of dosing. During the study, blood samples will be collected to assess the pharmacokinetics of ABT-333 according to the schedule in the protocol. Also, as safety assessment, physical examination, vital signs, ECG, Continuous Cardiac Monitoring, Clinical Laboratory Tests and Adverse Event Assessment are schedule in the protocol.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/53

• Date of REC Opinion

  25 Aug 2010

• REC opinion

  Further Information Favourable Opinion