A study to assess the safety of HF1020 in healthy male subjects

• Research type

  Research Study

• Full title

  A Randomised, Double-blind Placebo Controlled Study to Assess the Safety of Four Single Ascending Oral Doses of HF1020 in Healthy Male Subjects

• IRAS ID

  71789

• Contact name

  Dave Singh

• Sponsor organisation

  Trident Pharmaceuticals (c/o Advent Healthcare Ventures)

• Eudract number

  2010-023005-34

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a single-centre, randomised, double-blind, placebo-controlled, single ascending oral dose study, which aims to establish the safety and tolerability of HF1020 using parameters such as adverse events, changes in vital signs, ECG, telemetry and clinical laboratory tests. Total of 32 healthy male subjects will be randomised. Subjects will be enrolled sequentially into Cohort 1 - 4 (each with 8 subjects). Within cohorts, subjects will be randomised to either receive study drug (n=6) or placebo (n=2). HF1020/Placebo will be administered orally. The study treatments are as follows: 1. Cohort 1: Dose 1 (500 mg) 2. Cohort 2: Dose 2 (2.5 mg) 3. Cohort 3: Dose 3 (10 mg) 4. Cohort 4: Dose 4 (25 mg). Safety parameters will be reviewed at the Study Review Committee (SRC) meeting prior to dose escalation in the next cohort. Each subject may only participate in one cohort. This is a First in Human study of HF1020 therefore, in order to minimise the risk, within each cohort subjects 1 and 2 will be dosed at least 24 hours before subjects 3 and 4. Subjects 5-8 will then be dosed at least 24 hours after subject 4.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IEC07/1

• Date of REC Opinion

  14 Feb 2011

• REC opinion

  Further Information Favourable Opinion