Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus

Resolve Therapeutics

Status and phase: Completed; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: RSLV-132

Study type: Interventional

Funder types: Industry

Identifiers

NCT02194400

132-02

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Other biologic drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

32 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Saline infusion

Treatment:

Biological: RSLV-132

RSLV-132

Experimental group

Description:

0.3 - 10 mg/kg experimental drug

Treatment:

Biological: RSLV-132