Skip to main content
MedPathMedPath Home
Clinical Trials/NCT02194400
NCT02194400
Completed
Phase 1

A Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus Erythematosus

Resolve Therapeutics4 sites in 1 country32 target enrollmentJuly 2014
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsSystemic Lupus Erythematosus

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Systemic Lupus Erythematosus
Sponsor
Resolve Therapeutics
Enrollment
32
Locations
4
Primary Endpoint
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

A one month multi-dose study will evaluate the safety and tolerability of 3 intravenous infusions of RSLV-132 in subjects with inactive to mild SLE.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
November 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Stable SLE with no anticipated change in medications for the next 60 days

Exclusion Criteria

  • •Other biologic drugs

Outcomes

Primary Outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame: 30 days

Study Sites (4)

Loading locations...

Similar Trials

Completed
Phase 3
Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic SurgeryPostoperative PainHysterectomy
NCT00399568Mallinckrodt331
Completed
Phase 1
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ION547Healthy Volunteers
NCT04934891Ionis Pharmaceuticals, Inc.48
Completed
Phase 1
Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle GlaucomaOcular Hypertension (OHT)Mild Open Angle-glaucoma (OAG)
NCT01670266Ono Pharma USA Inc60
Completed
Phase 1
MED Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous WCK 5222 (Zidebactam and Cefepime) in Healthy VolunteersSerious Gram-negative Infections
NCT02707107Wockhardt20
Completed
Phase 1
Safety and Tolerability of Single and Multiple Doses of ISIS 353512 in Healthy VolunteersInflammatory Diseases
NCT00734240Ionis Pharmaceuticals, Inc.103