A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
Study identifier:D6080C00001
ClinicalTrials.gov identifier:NCT02780674
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1, Randomized, Blinded, Single-Dose, Dose escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
Medical condition
Dermatomyositis, polymyositis, Sjogren's, SLE, SSc
Phase
Phase 1
Healthy volunteers
No
Study drug
MEDI7734 1 mg, Placebo, MEDI7734 5 mg, MEDI7734 15 mg, MEDI7734 50 mg, MEDI7734 150 mg
Sex
All
Actual Enrollment
36
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 26 Aug 2016
Primary Completion Date: 23 Oct 2017
Study Completion Date: 27 Nov 2017
Study design
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2018 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI7734 1 mg Participants received a single dose of 1 milligram (mg) MEDI7734 subcutaneously on Day 1. | Drug: MEDI7734 1 mg Participants received a single dose of 1 milligram (mg) MEDI7734 subcutaneously on Day 1. |
| Placebo Comparator: Placebo Participants received a single dose of placebo matching with MEDI7734 subcutaneously on Day 1. | Drug: Placebo Participants received a single dose of placebo matching with MEDI7734 subcutaneously on Day 1. |
| Experimental: MEDI7734 5 mg Participants received a single dose of 5 mg MEDI7734 subcutaneously on Day 1. | Drug: MEDI7734 5 mg Participants received a single dose of 5 mg MEDI7734 subcutaneously on Day 1. |
| Experimental: MEDI7734 15 mg Participants received a single dose of 15 mg MEDI7734 subcutaneously on Day 1. | Drug: MEDI7734 15 mg Participants received a single dose of 15 mg MEDI7734 subcutaneously on Day 1. |
| Experimental: MEDI7734 50 mg Participants received a single dose of 50 mg MEDI7734 subcutaneously on Day 1. | Drug: MEDI7734 50 mg Participants received a single dose of 50 mg MEDI7734 subcutaneously on Day 1. |
| Experimental: MEDI7734 150 mg Participants received a single dose of 150 mg MEDI7734 subcutaneously on Day 1. | Drug: MEDI7734 150 mg Participants received a single dose of 150 mg MEDI7734 subcutaneously on Day 1. |
Contacts
Investigators
Principal Investigator
MedImmune LLC
MedImmune
