Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-2225 · 1 trial · 1 indication
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study/study treatment due to an AE will be reported.
| Arm | Type | Description |
|---|---|---|
| MK-2225 Panel A | EXPERIMENTAL | Participants receive MK-2225 Dose 1 subcutaneously (SQ) once every 2 weeks (Q2W) over the course of 8 weeks. |
| MK-2225 Panel B | EXPERIMENTAL | Participants receive MK-2225 Dose 2 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose. |
| MK-2225 Panel C | EXPERIMENTAL | Participants receive MK-2225 Dose 3 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose. |
| MK-2225 Panel D | EXPERIMENTAL | Participants receive MK-2225 Dose 4 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose. |
| Placebo | PLACEBO_COMPARATOR | Participants receive placebo SQ Q2W over the MK-2225-matched time period. |
| Name | Type | Description |
|---|---|---|
| MK-2225 | DRUG | Subcutaneous administration |
| Placebo | OTHER | Subcutaneous administration |
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health before randomization * Body Mass Index (BMI) ≤32 kg/m\^2, inclusive Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * History of clinical...
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MK-2225 is an investigational small molecule being developed for systemic sclerosis, a condition characterized by fibrosis and vascular damage. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and tolerability in clinical trials.
MK-2225 is being developed by Merck & Company, Inc., a global biopharmaceutical company. Merck is conducting clinical trials to evaluate the safety and tolerability of MK-2225 in healthy participants, as part of its early-stage research into treatments for systemic sclerosis.
MK-2225 is in Phase 1 clinical development. This early-stage trial is designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers. The drug is investigational and has not yet been approved for any use, as it is still undergoing clinical evaluation.
MK-2225 has one completed Phase 1 clinical trial, identified as NCT06643390. This study, titled 'A Study of MK-2225 in Healthy Participants (MK-2225-003)', enrolled 32 participants in the United States. It was a randomized, double-blind, placebo-controlled trial involving healthy volunteers aged 18 years and older.
No, MK-2225 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial was a safety and tolerability study in healthy participants, and the drug has not yet progressed through the later phases of clinical testing required for regulatory approval.