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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03395249 | Phase 1 Study of Safety, Tolerability and Pharmacokinetics of SPR994 | PHASE1 | COMPLETED | 124 | — | — | Oct 20, 2017 | Aug 2, 2018 | Aug 28, 2018 | 1 | Australia |
The incidence and severity of AEs
The type and frequency of medications used
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| Arm | Type | Description |
|---|---|---|
| SPR994, FI, F2, F3, F4 Oral Tablets | EXPERIMENTAL | SPR994 is active against multidrug-resistant Gram-negative and Gram-positive pathogens that cause serious and life-threatening infections, including extended spectrum beta-lactamase (ESBL) producers as well as strains resistant to levofloxacin and trimethoprim/sulfamethoxazole. SPR994 is administered in tablet form orally. Up to five different time released formulations of SPR994 will be studied in this protocol at 100 mg, 300 mg, 600 mg and 900 mg dosages. SAD Cohorts: One dose (two for food effect cohort) MAD Cohorts: Twenty-seven (27) doses administered twice daily (BID) over a period of 14 days or forty doses administered three times daily (TID) over period of 14 days |
| Placebo Oral Tablet | PLACEBO_COMPARATOR | Placebo tablets (100, 300, and 600 mg) are pressed from a single placebo blend consisting of the same inactive ingredients; the active pharmaceutical ingredient (API) is replaced by Mannitol 200SD. SAD Cohorts: One dose (two for food effect cohort) MAD Cohorts: Twenty-seven (27) doses administered BID over a period of 14 days or forty doses administered TID over a period of 14 days |
| Optional Orapenem Open-Label Control | OTHER | A single, optional, open-label, control cohort that may enroll, in which all 8 subjects receive Orapenem. SAD Cohort: One dose under fasted conditions and one dose under fed conditions. |
| Name | Type | Description |
|---|---|---|
| SPR994 | DRUG | SAD: Double-blind dosing will occur in all SAD Cohorts except for Cohort 12. In each cohort, six subjects will receive one of five different timed release formulations of SPR994 and 2 subjects will receive placebo. Subjects in SAD Cohorts 2, 3, 6, 16 and 17 will receive a single dose following a 10-h fast. Subjects in SAD Cohorts 1, 8-15 will receive one dose of SPR994 or placebo following a 10-h fast on Day 1 and a second dose following consumption of a standardized meal on Day 7. The dose escalation steps may be altered following review of the safety data of each cohort. MAD: Double-blind dosing will occur in all MAD Cohorts. Subjects will receive multiple doses of an optimal timed release formulation of SPR994 in MAD Cohort 4 (300 mg) and Cohort 5 (600 mg) or placebo for 14 consecutive days at either BID or TID dosing beginning on Day 1. |
| Placebo Oral Tablet | DRUG | Mannitol 200SD SAD: Two subjects in each cohort will receive matching placebo. MAD: Two participants in each cohort will receive matching placebo. |
| Orapenem® | DRUG | Tebipenem pivoxil granules |
Inclusion Criteria: * Healthy adult males and/or females (of non-childbearing potential), 18 to 55 years of age (inclusive) at the time of screening; * Body mass index ≥ 18.5 and ≤ 29.9 (kg/m2) and 55.0 and 100.0 kg (inclusive) for all cohorts; * Medically healthy without clinically significant (CS...