Phase 1 SAD/MAD Study with Subcutaneous ISIS 696844

• Research type

  Research Study

• Full title

  A Masked, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of ISIS 696844 Administered Subcutaneously to Healthy Volunteers.

• IRAS ID

  181566

• Contact name

  Adrian/J Stewart

• Contact email

  adrian.stewart@celerion.com

• Sponsor organisation

  Isis Pharmaceuticals, Inc.

• Eudract number

  2015-001837-25

• Duration of Study in the UK

  1 years, 0 months, 6 days

• Research summary

  This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD), and multiple ascending dose (MAD) study conducted at a single clinical site within the UK. Seventy-Eight Healthy male and female subjects (of non-child bearing potential) will be enrolled to investigate single subcutaneous doses of ISIS 696844 at 5 dose levels (Part 1) and multiple subcutaneous doses of ISIS 696844 at 5 dose levels (Part 2). In the multiple ascending dose regimens participants will receive 6 subcutaneous doses staggered over a 22 days period. The clinical indication for ISIS 696844age-related macular degeneration.

• REC name

  HSC REC B

• REC reference

  15/NI/0097

• Date of REC Opinion

  29 Jul 2015

• REC opinion

  Further Information Favourable Opinion