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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01818024 | A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers | PHASE1 | COMPLETED | 54 | — | — | Feb 22, 2013 | Oct 25, 2013 | May 15, 2017 | 1 | United Kingdom |
Safety and tolerability parameters will include recording of adverse events (AEs), throughout the study.
Safety and tolerability parameters will include recording of AEs, throughout the study.
Laboratory tests will include haemogram, clinical chemistry, urine examination.
Laboratory tests will include haemogram, clinical chemistry, urine examination.
Vital signs will include blood pressure (BP), heart rate respiration rate and body temperature.
Vital signs will include BP, heart rate respiration rate and body temperature.
Safety data will include electrocardiogram (ECG) readings obtained at each timepoint during the study.
Safety data will include ECG readings obtained at each timepoint during the study.
Spirometry monitoring will include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).
Spirometry monitoring will include FEV1 and FVC.
Blood samples will be collected for assessment of plasma cytokines.
Presence of anti GSK2862277 binding antibodies will be evaluated.
Presence of anti GSK2862277 binding antibodies will be evaluated.
| Arm | Type | Description |
|---|---|---|
| Part 1: Cohort 1a | EXPERIMENTAL | Single IV dose of GSK2862277 as a continuous infusion over 2 hours. |
| Part 1: Cohort 1b | EXPERIMENTAL | Single IV dose of GSK2862277 as a continuous infusion over 3 hours. |
| Part 1: Cohort 1c | EXPERIMENTAL | Single IV dose of GSK2862277 as a continuous infusion over 3 hours. |
| Part 2: Cohort 2a GSK2862277 | EXPERIMENTAL | Single IV dose of GSK2862277 as a continuous infusion over 1 hour. |
| Part 2: Cohort 2a Placebo | EXPERIMENTAL | Matching placebo will be administered as a continuous IV infusion over 1 hour. |
| Part 2: Cohort 2b GSK2862277 | EXPERIMENTAL | Single IH dose of GSK2862277. |
| Part 2: Cohort 2b Placebo | EXPERIMENTAL | Matching placebo will be administered. |
| Part 3: Cohort 3a GSK2862277 | EXPERIMENTAL | IV dose of GSK2862277 (decided from Part 2) as a continuous infusion over 1 hour for daily 5 days. |
| Part 3: Cohort 3a Placebo | EXPERIMENTAL | Matching placebo will be administered as IV infusion over 1 hour daily for 5 days. |
| Part 3: Cohort 3b GSK2862277 | EXPERIMENTAL | Repeat IH dose of GSK2862277 (decided from Part 2) daily for 5 days. |
| Part 3: Cohort 3b Placebo | EXPERIMENTAL | Matching placebo will be administered as IH daily for 5 days. |
| Name | Type | Description |
|---|---|---|
| Single IV dose of GSK2862277 | DRUG | GSK2862277 solution available in a 40 mg vial for IV administration. |
| Matching placebo single dose IV infusion | DRUG | Matching placebo solution available for IV administration. |
| Single IH dose of GSK2862277 | DRUG | GSK2862277 nebulised solution available in a 40 mg vial for IH administration. |
| Matching placebo single dose IH | DRUG | Matching placebo nebulised solution available for IH administration. |
| Repeat IV dose of GSK2862277 | DRUG | GSK2862277 solution available in a 40 mg vial for IV administration. |
| Matching placebo repeat dose IV infusion | DRUG | Matching placebo solution available for IV administration. |
| Repeat IH dose selected of GSK2862277 from Part 2 | DRUG | GSK2862277 nebulised solution available in a 40 mg vial for IH administration. |
| Matching placebo repeat dose IH | DRUG | Matching placebo nebulised solution available for IH administration. |
Inclusion Criteria: * Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Ralinepag, Treprostinil |
| AstraZeneca PLC | AZN | 2 | — | Undisclosed |
| Intuitive Surgical, Inc. | ISRG | 1 | — | Undisclosed |
| Masimo Corporation | MASI | 1 | NA | Undisclosed |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | — | Undisclosed |