Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPR741 · 2 trials · 1 indication
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
The frequency and type of adverse events
Clinical laboratory testing - change from baseline to end of study visit
Change from baseline to end of study visit
Change from baseline to end of study visit
Change from baseline to end of study visit
Change from baseline to end of study visit
| Arm | Type | Description |
|---|---|---|
| SPR741/Ceftazidime (N=9) | EXPERIMENTAL | Nine (9) participants will be enrolled and assigned to receive SPR741 400 mg IV over 1 hour, SPR741 400 mg IV over 1 hour + ceftazidime1.0 gram IV over 1 hour, and ceftazidime 1.0 gram IV over 1 hour in a randomized sequence. One treatment will be administered during each of 3 dose periods within the assigned treatment arm. |
| SPR741/Piperacillin/tazobactam (N=9) | EXPERIMENTAL | Nine (9) participants will be enrolled and assigned to receive SPR741 400 mg IV over 1 hour, SPR741 400 mg IV over 1 hour + piperacillin/tazobactam 4.5 grams IV over 1 hour, and piperacillin/tazobactam 4.5 grams IV over 1 hour in a randomized sequence. One treatment will be administered during each of 3 dose periods within the assigned treatment arm. |
| SPR741/Aztreonam (N=9) | EXPERIMENTAL | Nine (9) participants will be enrolled and assigned to receive SPR741 400 mg IV over 1 hour, SPR741 400 mg IV over 1 hour + aztreonam 1.0 gram IV over 1 hour, and aztreonam 1.0 gram IV over 1 hour in a randomized sequence. One treatment will be administered during each of 3 dose periods within the assigned treatment arm. |
| SPR741 | EXPERIMENTAL | SPR741 is a novel chemical entity known as a potentiator that specifically interacts with the outer membrane of Gram-negative bacteria to increase the membrane's permeability. This increase in permeability allows Gram-positive antibiotics to enter and kill the cell. SAD cohorts: Subjects will receive single doses of SPR741 over 60 minute IV infusion. Planned doses to be studied are 5, 15, 50, 100, 200, 400, 600 and 800 mg. MAD cohorts: Subjects will receive SPR741 over 60 minute IV infusion three times a day (TID). Four dose groups will be studied. Doses will be determined by assessing SAD cohort data. |
| Placebo | PLACEBO_COMPARATOR | The placebo used during this study is normal saline (0.9% sodium chloride for injection). SAD: Subjects will receive single infusions of placebo (0.9% sodium chloride for injection) over 60 minutes. MAD: Subjects will receive TID infusions of placebo over 60 minutes for 14 days |
| Name | Type | Description |
|---|---|---|
| SPR741 | DRUG | 400 mg IV over 1 hour |
| Ceftazidime | DRUG | 1.0 gram IV over 1 hour |
| Piperacillin/tazobactam | DRUG | 4.5 grams IV over 1 hour |
| Aztreonam | DRUG | 1.0 gram IV over 1 hour |
| Placebo | DRUG | 0.9% sodium chloride for injection. SAD: Two participants in each cohort will receive matching placebo. MAD: Two participants in each cohort will receive matching placebo. |
Inclusion Criteria: 1. Healthy adult males and/or females (of non-childbearing potential), 18 to 55 years of age (inclusive) at the time of screening; 2. BMI ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive); 3. Medically healthy without clinically significant abnormalities...
SPR741 is a small molecule therapeutic candidate developed by Spero Therapeutics, Inc. It has been studied in Phase 1 clinical trials involving healthy adult volunteers. The specific disease indications for SPR741 have not been publicly disclosed, and the program is in early-stage clinical development.
SPR741 is being developed by Spero Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol SPRO. Spero Therapeutics is the sponsor of the clinical trials conducted for SPR741 to date.
SPR741 is in Phase 1 clinical development. Both of its recorded trials were Phase 1 studies, and both have been completed. The drug has not been approved by the FDA and remains an investigational candidate.
SPR741 has been evaluated in two completed Phase 1 trials. NCT03022175 was a first-in-human study of single and multiple doses in 64 healthy volunteers in Australia. NCT03376529 evaluated drug-drug interactions, pharmacokinetics, safety, and tolerability in 27 healthy volunteers in the United Kingdom.
Both SPR741 trials were randomized, double-blind, and controlled Phase 1 studies conducted in healthy adult volunteers aged 18 and older. Together they enrolled 91 participants. NCT03022175 tested single and multiple ascending doses, while NCT03376529 assessed drug-drug interactions and pharmacokinetics.