Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GS-5745 · 2 trials · 2 indications
This composite endpoint will measure the safety and tolerability profile of GS-5745.
This composite endpoint will measure the plasma PK profile of GS-5745. The following parameters will be measured, where applicable: * Cmax: maximum observed concentration of drug in plasma * AUClast: concentration of drug from time zero to the last quantifiable concentration * AUC0-inf: area under the plasma concentration versus time curve starting with time zero to infinity
| Arm | Type | Description |
|---|---|---|
| GS-5745 | EXPERIMENTAL | Participants will receive GS-5745 every 2 weeks for a total of 3 infusions. |
| Placebo to match GS-5745 | PLACEBO_COMPARATOR | Participants will receive placebo to match GS-5745 every 2 weeks for a total of 3 infusions. |
| GS-5745 SC | EXPERIMENTAL | Participants will receive a single dose of GS-5745 by SC injection. |
| GS-5745 IV | EXPERIMENTAL | Participants will receive a single dose of GS-5745 by IV infusion. |
| Name | Type | Description |
|---|---|---|
| GS-5745 | DRUG | GS-5745 400 mg administered intravenously |
| Placebo to match GS-5745 | DRUG | Placebo to match GS-5745 administered intravenously |
| GS-5745 SC | DRUG | GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe |
| GS-5745 IV | DRUG | GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials |
Inclusion Criteria: * 18 to 70 years of age, inclusive, at time of screening * Weight: ≥ 45 to \< 120 kg * Males or non-pregnant, non-lactating females * Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) for the classification of RA * Active disease, defined as a ...
Top 20 of 28 competitors
GS-5745 is an investigational small molecule being developed for ulcerative colitis and rheumatoid arthritis. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied for its safety, tolerability, and pharmacokinetics in these conditions.
GS-5745 is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. The drug is currently in Phase 1 clinical trials for ulcerative colitis and rheumatoid arthritis.
GS-5745 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. Clinical trials have been completed for rheumatoid arthritis and healthy adults, with the drug being studied for ulcerative colitis.
GS-5745 has completed two Phase 1 trials. NCT02176876 studied the drug in 18 subjects with rheumatoid arthritis in Czechia and Hungary. NCT02209987 assessed subcutaneous GS-5745 in 28 healthy adults in New Zealand, with conditions listed as ulcerative colitis.
GS-5745 is the primary name for this investigational small molecule developed by Gilead Sciences. No alternative names have been reported for this drug in clinical development for ulcerative colitis and rheumatoid arthritis.