Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
subcutanious administration · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| COHORT 1: CUMULATIVE DOSE 1.5MG, ADMINISTERED SUBCUTANEOUSLY | EXPERIMENTAL | Duration of treatment 3 days, dose 0.3, 0.5, 0.7, four patients in cohort, one of which is on placebo, escalation increment N/A |
| COHORT 2: CUMULATIVE DOSE 3.5MG, ADMINISTERED SUBCUTANEOUSLY | EXPERIMENTAL | Duration of treatment 5 days, dose 0.3, 0.5, 0.7, 1.0, 1.0 four patients in cohort, one of which is on placebo, escalation increment 2.3 fold. |
| COHORT 3: CUMULATIVE DOSE 6.0MG, ADMINISTERED SUBCUTANEOUSLY | EXPERIMENTAL | Duration of treatment 7 days, dose 0.3, 0.7, 5 x 1.0 four patients in cohort, one of which is on placebo, escalation increment 1.7 fold. |
| COHORT 4: CUMULATIVE DOSE 8.0MG, ADMINISTERED SUBCUTANEOUSLY | EXPERIMENTAL | Duration of treatment 5 days, dose 0.3, 0.7, 1.0, 2 x 3.0 four patients in cohort, one of which is on placebo, escalation increment 1.33 fold. |
| COHORT 5: CUMULATIVE DOSE 10MG, ADMINISTERED SUBCUTANEOUSLY | EXPERIMENTAL | Duration of treatment 10 days, dose 10 x 1.0 four patients in cohort, one of which is on placebo, escalation increment 1.25 fold. |
| COHORT 6: CUMULATIVE DOSE 15MG, ADMINISTERED SUBCUTANEOUSLY | EXPERIMENTAL | Duration of treatment 15 days, dose 15 x 1.0 six patients in cohort, one of which is on placebo, escalation increment 1.5 fold. |
| COHORT 7: CUMULATIVE DOSE 15MG, ADMINISTERED SUBCUTANEOUSLY | EXPERIMENTAL | Duration of treatment 5 days, dose 5 x 3.0 six patients in cohort, one of which is on placebo, escalation increment N/A |
| Name | Type | Description |
|---|---|---|
| subcutanious administration | DRUG | drug will be administered subcutaneously in varying amounts over a verying time period according to details stated in the 'arms' section |
| Placebo | OTHER | Placebo will be given to one member of each cohort. |
Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male or female subjects between 18 and 75 years of age inclusive. 2. A female subject is eligible to participate if she is of: 1. Non-childbearing potential defined as pre...
Subcutanious administration is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It is currently in Phase 1 clinical development, with one completed trial involving 28 participants in Russia. The drug is not yet approved and remains under investigation for this indication.
The molecular target of subcutanious administration has not been disclosed. As a small molecule in the immunology therapeutic area, it is being evaluated for its potential effects in rheumatoid arthritis, but its specific mechanism of action is not publicly available at this time.
Subcutanious administration is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research to evaluate this investigational small molecule for rheumatoid arthritis.
Subcutanious administration is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for rheumatoid arthritis, and its safety and efficacy are still being evaluated in early-stage clinical trials.
Subcutanious administration has one completed clinical trial, NCT01101555, titled 'Repeat Dose Subcutaneous Rhumatoid Arthritis Efficacy Study'. This Phase 1 study enrolled 28 participants with rheumatoid arthritis in Russia. The trial was controlled and randomized, though not double-blind, and has been completed.