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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03450187 | A Phase 1 TP-271 Oral PK Multiple Ascending Dose Study | PHASE1 | COMPLETED | 40 | — | — | Mar 20, 2018 | Mar 31, 2019 | Dec 17, 2021 | 1 | United States |
| NCT03234738 | A Phase 1 Safety and PK Study of IV TP-271 | PHASE1 | COMPLETED | 40 | — | — | Aug 16, 2017 | Jan 2, 2018 | Dec 13, 2021 | 1 | United States |
| NCT03024034 | A Phase 1 TP-271 Oral PK Single Ascending Dose Study | PHASE1 | COMPLETED | 56 | — | — | Mar 2, 2017 | Jun 4, 2018 | Dec 13, 2021 | 1 | United States |
Incidence, intensity, and type of adverse events.
changes in physical examination findings for chest/respiratory
Changes in Physical Examination including heart/cardiovascular
Changes in Pulse Rate
Changes in respiration rate
Changes in body temperature
Changes in blood pressure
Changes in PR interval \> or=20
Changes in QRS interval\> or=10
Changes in QTcF interval 30 to 60, \> or =60
Changes in safety laboratory results including clinical chemistry
Changes in safety laboratory results including electrolytes
Changes in safety laboratory results including hematology
Changes in Safety laboratory results including glucose
Changes in Safety Laboratory results including coagulation
Changes in physical examination findings between Day -1 and the EOS Visit
Changes in vital signs from Day -1 through the EOS Visit
Changes in safety laboratory (clinical chemistry, electrolytes, hematology, blood glucose, and coagulation) results from Day -1 through the EOS Visit
Changes in electrocardiogram (ECG) measurements from Day -1 through the EOS Visit
The incidence, intensity, and type of adverse events (AE) and the total number of participants experiencing AEs that are related to treatment Outcome measures to be collected in support of the primary objective (safety and tolerability) include: * The incidence, intensity, and type of AEs (from time of signing of informed consent form \[ICF\] through EOS); * Changes in physical examination findings (Day -1 and EOS); * Changes in vital signs (Day -1 through EOS); * Changes in safety laboratory (chemistry, hematology, coagulation, urinalysis) results (Days -1 through EOS); and * Changes in ECG measurements (Days -1 through EOS).
Changes in safety laboratory (chemistry, hematology, coagulation, urinalysis) results that are considered abnormal, clinically significant and related to treatment
| Arm | Type | Description |
|---|---|---|
| Cohort A | ACTIVE_COMPARATOR | 50 mg TP-271 q24 (n=6), a novel, broad-spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. |
| Cohort B | ACTIVE_COMPARATOR | 100 mg TLP-271 q24 (n=6), a novel, broad spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. |
| Cohort C | ACTIVE_COMPARATOR | 200 mg TP-271 q24 (n=6), a novel, broad spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. |
| Cohort D | ACTIVE_COMPARATOR | 300 mg TP-271 q24 (n=6), a novel, broad spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. |
| Cohort E | ACTIVE_COMPARATOR | 400 mg TP-271 q24 (n=6), a novel, broad spectrum tetracycline-class antibiotic or matching placebo (n=2) once daily for 7 days. |
| Cohort F | ACTIVE_COMPARATOR | Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 300 mg single dose (n = 6) or matching placebo (n = 2) |
| Cohort G | ACTIVE_COMPARATOR | Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 50 mg TP 271, cross-over to 50 mg TP 271/250 mg EDTA (n = 3); 50 mg TP 271/250 mg EDTA, cross-over to 50 mg TP 271 (n = 3); matching placebo, cross over to 250 mg EDTA (n= 1); or 250 mg EDTA, cross over to matching placebo (n = 1) |
| Name | Type | Description |
|---|---|---|
| TP-271 | DRUG | multiple oral doses of TP-271 or placebo, randomized 6:2, doses escalating 50 mg, 100 mg, 200 mg, 300 mg, 400 mg once daily for 7 days. |
| Placebo | DRUG | Placebo is sterile 0.45% saline randomized 3:1 to receive |
Inclusion Criteria: 1. Be within the age range of 18 to 50 years, inclusive, at the time of Screening 2. Voluntarily sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved ICF to participate in the study after all relevant aspects of the study have been explained to an...