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Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration

NCT02083666 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-07-28

No results posted yet for this study

Summary

The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.

Conditions

  • Healthy

Interventions

DRUG

SOBI002

Test Product

DRUG

Placebo

Reference product

Sponsors & Collaborators

  • Richmond Pharmacology Limited

    collaborator INDUSTRY

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • Erik Brouwer, MD · Swedish Orphan Biovitrum AB (publ)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-11-30
Completion
2015-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02083666 on ClinicalTrials.gov