3 completed, 1 terminated. 2 Phase 3, 1 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 2 | Completed 1, Terminated 1 |
| Phase 1 | 1 | Completed 1 |
| Phase 2 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury Reltecimod 0.5 mg/kg, Placebo - Acute Kidney Injury, Peritonitis | Phase 3 | Terminated | Atox Bio Ltd | 58 | 2018-05-24 | 2021-10-12 |
| Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections AB103 0.5 mg/kg, NaCl 0.9% - Necrotizing Soft Tissue Infections, Necrotizing Fasciitis | Phase 3 | Completed | Atox Bio Ltd | 290 | 2015-12-01 | 2021-10-05 |
| Evaluation of Safety, PK and Immunomodulatory Effects of AB103 in Necrotizing Soft Tissue Infections Patients AB103, Placebo - Necrotizing Soft Tissue Infections | Phase 2 | Completed | Atox Bio Ltd | 43 | 2011-12-01 | 2021-08-18 |
| AB103 Peptide Antagonist in Healthy Volunteers AB103, Placebo - Healthy Volunteer Safety Study | Phase 1 | Completed | Atox Bio Ltd | 25 | 2010-09-01 | 2021-06-09 |
Acute Kidney Injury (1) · Fasciitis, Necrotizing (1) · Fournier Gangrene (1) · Intraabdominal Infections (1) · Peritonitis (1) · Sepsis (1) · Shock, Septic (1)
AB103 (4) · Saline Solution (2) · Sodium Chloride (2)
United States (4) · France (2)
Alan Cross, MD (1) · Azra Bihorac, MD (1) · Eileen M Bulger, MD (1) · Wayne M Dankner, MD (1)