Spero Therapeutics, Inc.
SPROHealthcare|Biotechnology|US
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Clinical Trials (24)
| Trial | Conditions | Phase | Status | Enrollment | Design | Drug |
|---|---|---|---|---|---|---|
| NCT03788967 Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) | Complicated Urinary Tract Infection, Acute Pyelonephritis | P3 | Completed | 1,372 | RCT, Double-blind | TBPM-PI-HBr, Ertapenem, Dummy Infusion, Dummy tablets |
| NCT06059846 A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) | Urinary Tract Infection, Acute Pyelonephritis | P3 | Completed | 1,690 | RCT, Double-blind | TBP-PI-HBr, Imipenem-cilastatin, Dummy Infusion, Dummy Tablets |
| NCT05496374 A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease | Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) | P2 | Completed | 25 | RCT, Double-blind | Placebo, SPR720 500 mg, SPR720 1000 mg |
| NCT04553406 Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease | Mycobacterium Avium Complex, Non-tuberculous Mycobacterium Pulmonary Disease | P2 | Terminated | 2 | RCT, Double-blind | SPR720, Placebo, Open-label Standard of Care |
| NCT03022175 A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR741 in Healthy Volunteers | Healthy Volunteers | P1 | Completed | 64 | RCT, Double-blind | SPR741, Placebo |
| NCT04376554 Effect of Tebipenem on Normal Human Intestinal Microbiota | Healthy Volunteers | P1 | Completed | 30 | RCT, Open-label | TBPM-PI-HBr, amoxicillin-clavulanate |
| NCT04919954 Tebipenem (SPR994) Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis | Diabetes, Wound Infection | P1 | Completed | 12 | Open-label | Tebipenem Pivoxil Hydrobromide |
| NCT05856747 A Study to Compare Two Bioanalytical Assays for Tebipenem | Healthy Volunteers | P1 | Completed | 20 | Open-label | TBP-PI-HBr |
| NCT04238195 A Single-Dose, Randomized, Placebo- and Active-Control, Four-Way, Cross-Over Study for the Evaluation of the Effect of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) on the QT/QTc Intervals in Adult Healthy Subjects | TQT Study | P1 | Completed | 24 | RCT, Double-blind | Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + Placebo, Moxifloxacin 400mg, Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) |
| NCT03395249 Phase 1 Study of Safety, Tolerability and Pharmacokinetics of SPR994 | Healthy Volunteers | P1 | Completed | 124 | RCT, Double-blind | SPR994, Placebo Oral Tablet, Orapenem® |
| NCT05955586 A Study to Assess the Intrapulmonary Pharmacokinetics (PK) of SPR719 by Comparing the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations Following the Oral Administration of Multiple Doses of SPR720 in Healthy Volunteers. | Healthy Volunteer | P1 | Completed | 33 | Open-label | SPR720 |
| NCT04421885 Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects | Healthy Volunteers | P1 | Completed | 36 | RCT, Open-label | Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference, Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test |
| NCT05296382 Bioavailability of Tebipenem (SPR994) Crushed Tablet | Relative Bioavailability | P1 | Completed | 12 | RCT, Open-label | Tebipenem tablet form |
| NCT04865393 Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function | Renal Impairment | P1 | Completed | 37 | Open-label | SPR206 |
| NCT04368585 Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects | Healthy Volunteers | P1 | Completed | 20 | Open-label | Tebipenem pivoxil hydrobromide (TBPM-PI-HBr), 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL), Omeprazole |
| NCT04625855 Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects | Healthy Volunteers | P1 | Completed | 8 | Open-label | TBPM-PI-HBr |
| NCT03796910 A Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 in Healthy Volunteers | Healthy Volunteers | P1 | Completed | 96 | RCT, Double-blind | SPR720 for SAD, Placebo for SAD, SPR720 for MAD, Placebo for MAD |
| NCT03792308 A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR206 in Healthy Volunteers | Healthy Volunteers | P1 | Completed | 94 | RCT, Double-blind | SPR206, Placebo |
| NCT06727136 A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants | Healthy Participants | P1 | Completed | 39 | RCT, Open-label | TBP-PI-HBr |
| NCT04710407 Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers | Healthy Volunteers | P1 | Completed | 30 | Open-label | TBPM-PI-HBr |
| NCT04178577 Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal Function | Renal Impairment | P1 | Completed | 39 | Open-label | Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) |
| NCT05966688 A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants | Healthy Volunteers | P1 | Completed | 39 | Open-label | SPR720, Azithromycin, Ethambutol |
| NCT03376529 Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741 | Healthy Volunteers | P1 | Completed | 27 | RCT, Open-label | SPR741, Ceftazidime, Piperacillin/tazobactam, Aztreonam |
| NCT04868292 Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy Volunteers | Healthy Volunteers | P1 | Completed | 34 | Open-label | SPR206 |