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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03036163 | Phase 1 Study of PBTZ169 | PHASE1 | COMPLETED | 40 | — | — | Jan 1, 2016 | Nov 1, 2016 | Apr 13, 2020 | - | — |
The frequency of adverse events for which a relationship to the test drug PBTZ169 was noted
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 40 mg (1 capsule) |
| Cohort 2 | EXPERIMENTAL | 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 80 mg (2 capsules) |
| Cohort 3 | EXPERIMENTAL | 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 160 mg (4 capsules) |
| Cohort 4 | EXPERIMENTAL | 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 320 mg (8 capsules) |
| Cohort 5 | EXPERIMENTAL | 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 640 mg (16 capsules) |
| Cohort 6 | EXPERIMENTAL | 5 male healthy volunteers each of whom received once daily for 14 days 320 mg of PBTZ169 (8 capsules 40 mg) |
| Cohort 7 | EXPERIMENTAL | 5 male healthy volunteers each of whom received once daily for 14 days 640 mg of PBTZ169 (16 capsules 40 mg) |
| Name | Type | Description |
|---|---|---|
| PBTZ169 - 40 mg | DRUG | 40 mg of PBTZ169 (1 capsule) orally once in fasting state |
| PBTZ169 - 80 mg | DRUG | 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state |
| PBTZ169 - 160 mg | DRUG | 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state |
| PBTZ169 - 320 mg | DRUG | 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state |
| PBTZ169 - 640 mg | DRUG | 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state |
| PBTZ169 - 320 mg (multiple administration) | DRUG | 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days |
| PBTZ169 - 640 mg (multiple administration) | DRUG | 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days |
Inclusion Criteria: 1. Written informed consent received from a volunteer. 2. Man aged 18 to 45 years old, inclusive. 3. Body mass index of 18.5-25 kg/m2. 4. Verified diagnosis: "healthy" according to data of standard clinical, laboratory and instrumental examination methods performed at screening:...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Viatris, Inc. | VTRS | 1 | PHASE3 | Bedaquiline |
| Johnson & Johnson | JNJ | 1 | PHASE2 | Bedaquiline, Background Regimen |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT164a1, BNT164b1 |
| Harvard Bioscience, Inc. | HBIO | 1 | — | Bdq, Lzd, Lfx, Dlm, Cfz |