Safety, PK and food effect of RV521 in healthy male volunteers

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, single and multiple ascending dose study of orally administered RV521 to evaluate the safety, tolerability, pharmacokinetics, and food effect in healthy adult male volunteers.

• IRAS ID

  208558

• Sponsor organisation

  ReViral Ltd

• Eudract number

  2016-002091-28

• Duration of Study in the UK

  0 years, 6 months, 8 days

• Research summary

  We are conducting a first-in-human clinical study in RV521 in healthy Caucasian and Japanese male volunteers. RV521 is being developed by ReViral Ltd as a treatment for Respiratory Syncitial Virus (RSV), which can cause severe (and often fatal) chest infections in small children, adults with heart, lung and immune system conditions and elderly people. This study will be the first time RV521 has been administered to humans. \nThere are currently no vaccines to prevent RSV infection and treatment options are limited to two drugs: Ribavirin is approved for the treatment of RSV but not widely used due to its toxicity and limited efficacy. Paluvizimab is approved for RSV prevention in infants at high risk of disease, but not used in adults due to limited efficacy data and cost. \nIn this study we will assess the safety and tolerability of orally-administered RV521 when it is given as a single dose (SAD) in Part A of the study (Part Ai: up to 48 healthy Caucasian volunteers in 6 – 8 cohorts; Part Aii: up to 12 healthy Japanese volunteers in 2 - 3 cohorts) and placebo-controlled multiple doses (MAD) in Part B (up to 40 healthy Caucasian volunteers in 3 – 5 cohorts). We will also measure how much RV521 is found in the blood after oral dosing (i.e. pharmacokinetics). In Parts A and B, we plan to increase the dose from one cohort to the next, subject to no safety issues being identified. The potential food effect on RV521 will be assessed in Part C; 8 volunteers will receive RV521 as a single dose on two separate occasions (once after a high fat breakfast, and once fasted). \nWe will assess safety parameters including physical examination, vital sign measurements, laboratory evaluations, electrocardiogram (ECG) and monitoring of adverse events (AEs).\n

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  16/SC/0303

• Date of REC Opinion

  24 Aug 2016

• REC opinion

  Favourable Opinion