Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Single dose of GSK2862277 · 1 trial · 1 indication
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 |
| AstraZeneca PLC | AZN | 2 | - | Undisclosed |
| Intuitive Surgical, Inc. | ISRG | 1 | - | Undisclosed |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | - | Undisclosed |
GSK2862277 is an investigational small molecule being studied for respiratory disorders. It is administered by inhaled and intravenous routes. The drug is in Phase 1 clinical development, meaning it is still being tested in clinical trials and is not yet approved for any use.
GSK2862277 is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this investigational drug for respiratory disorders.
GSK2862277 is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the drug in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
GSK2862277 has one completed clinical trial, registered as NCT01818024. This study investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled and intravenous GSK2862277 in healthy volunteers. The trial was conducted in the United Kingdom with 54 participants.
The completed clinical trial for GSK2862277 was a controlled study, meaning participants were assigned to receive either the active drug or a control. The trial was randomized but not double-blind. It enrolled healthy volunteers aged 18 years and older.