Systemic Lupus Erythematosus (SLE) Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Characteristics of SG301 SC Injection in Single-dose Healthy Subjects and Multiple-dose Systemic Lupus Erythematosus (SLE) Subjects
This is a randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single dose in healthy volunteers and multiple doses of SG301 SC injection in participants with systemic lupus erythematosus (SLE).
This is a phase I single ascending dose (SAD) study in healthy volunteers and multiple ascending dose (MAD) study in participants with mild or moderate SLE, which consists of Parts A and B. Part A adopts a single-center, open-label, dose escalation trial design, and Part B adopts a multi-center, randomized, double-blind, placebo-controlled trial design to evaluate the safety, tolerability, PK, and immunogenicity, preliminary efficacy of SG301 SC Injection in patients with mild to moderate SLE. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04461158 -
CCCR Lupus Patient Navigator Program
|
N/A | |
| Completed |
NCT02006784 -
Pilot Study to Assess Flares Following Inactivated Influenza Vaccine in Children With Systemic Lupus Erythematosus (SLE)
|
N/A | |
| Completed |
NCT01072734 -
Auto-immunity in Lupus Patients After Influenza Vaccine
|
Phase 2 | |
| Completed |
NCT03626311 -
Omega-3 Replacement With Krill Oil in Disease Management of SLE
|
N/A | |
| Withdrawn |
NCT02779153 -
Acthar SLE (Systemic Lupus Erythematosus)
|
Phase 4 | |
| Completed |
NCT01992666 -
GENetic & Immunologic Abnomalies in Systemic Lupus Erythematosus
|
N/A | |
| Completed |
NCT00779194 -
Prospective Study of Rapamycin for the Treatment of SLE
|
Phase 2 | |
| Recruiting |
NCT00582881 -
Characteristics and Disease Progression of Mixed Connective Tissue Disease and Systemic Lupus Erythematosus
|
||
| Terminated |
NCT02811094 -
LUMIER² Study : LUpus Molecular Immunomonitoring to Evaluate the Risk of Relapse
|
N/A | |
| Recruiting |
NCT05458622 -
3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erithematosus Study Protocol
|
Phase 3 | |
| Completed |
NCT03031925 -
Detection of Annexin A2 in Systemic Lupus Erythematosus
|
N/A | |
| Not yet recruiting |
NCT06420154 -
The Safety and Efficacy of Anti-CD19 CAR-T Cells in Patients With Relapsed/Refractory Autoimmune Diseases
|
Early Phase 1 | |
| Recruiting |
NCT05859997 -
Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases
|
N/A | |
| Recruiting |
NCT02782039 -
Register of Patients With Anti-Phospholipids Syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)
|
||
| Recruiting |
NCT05567198 -
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
|
||
| Recruiting |
NCT05747651 -
3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2
|
||
| Recruiting |
NCT03030976 -
A Study of CD19 Redirected Autologous T Cells for CD19 Positive Systemic Lupus Erythematosus (SLE)
|
Phase 1 | |
| Recruiting |
NCT06249438 -
A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
|
Phase 1 | |
| Not yet recruiting |
NCT05724940 -
Comparison of Clinical and Serological Differences Among Juvenile, Adult, and Late-onset Systemic Lupus Erythematosus
|
||
| Recruiting |
NCT06032923 -
Double-blind Placebo Controlled Study to Evaluate the Effect of NAD+ Boosting With Nicotinamide Riboside on Immunometabolism and Immunity in Systemic Lupus Erythematosus
|
Phase 1/Phase 2 |