Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2025-12-24 @ 4:33 PM
NCT ID:
NCT02083666
Brief Summary:
The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.
Detailed Description:
This is a double-blind, placebo-controlled, randomized within dose cohort single and repeated dose study with sequential dose escalation.
Eligible volunteers will be divided into dose cohorts and for each cohort, a new panel of 8 volunteers will be randomized to receive either SOBI002 (n=6) or placebo (n=2). SOBI002 will either be administered subcutaneously or intravenously.
Study:
NCT02083666
Study Brief:
Protocol Section:
NCT02083666