Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03376529 | Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741 | PHASE1 | COMPLETED | 27 | — | — | Nov 10, 2017 | Dec 20, 2017 | Jan 5, 2018 | 1 | United Kingdom |
| NCT03022175 | A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR741 in Healthy Volunteers | PHASE1 | COMPLETED | 64 | — | — | Dec 1, 2016 | Sep 1, 2017 | Oct 5, 2017 | 1 | Australia |
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...