Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-6194 · 4 trials · 3 indications
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Blood samples will be collected to determine the AUC0-Last of MK-6194.
Blood samples will be collected to determine the AUC0-Inf of MK-6194.
Blood samples will be collected to determine the Cmax of MK-6194.
Blood samples will be collected to determine the Tmax of MK-6194.
Blood samples will be collected to determine the CL/F of MK-6194.
Blood samples will be collected to determine the t1/2 of MK-6194.
Blood samples will be collected to determine the Vz/F of MK-6194.
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study intervention due to an AE is presented.
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.
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 thestudy intervention
| Arm | Type | Description |
|---|---|---|
| Panel A | EXPERIMENTAL | Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 1) or Placebo. |
| Panel B | EXPERIMENTAL | Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 2) or Placebo. |
| Panel C | EXPERIMENTAL | Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 3) or Placebo. |
| Abdomen Injection | EXPERIMENTAL | Participants will receive a single dose of MK-6194 injected into the abdomen. |
| Thigh Injection | EXPERIMENTAL | Participants will receive a single dose of MK-6194 injected into the thigh. |
| Dose Escalation Panel A | EXPERIMENTAL | Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w). |
| Dose Escalation Panel B | EXPERIMENTAL | Participants are randomized to medium dose MK-6194 or placebo administered q2w. |
| Dose Escalation Panel C | EXPERIMENTAL | Participants are randomized to high dose MK-6194 or placebo administered q2w. |
| Expansion Panel D | EXPERIMENTAL | Participants are randomized to medium dose MK-6194 or placebo administered q2w. |
| Expansion Panel E | EXPERIMENTAL | Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w. |
| Expansion Dose F | EXPERIMENTAL | Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w. |
| MK-6194 Low Dose - Interval 1 (Less Frequent) | EXPERIMENTAL | Participants received low dose of MK-6194 at specified less frequent intervals |
| MK-6194 Medium Dose- Interval 2 (More Frequent) | EXPERIMENTAL | Participants received medium dose of MK-6194 at specified more frequent intervals |
| MK-6194 High Dose- Interval 2 (More Frequent) | EXPERIMENTAL | Participants received high dose of MK-6194 at specified more frequent intervals |
| MK-6194 High Dose- Interval 1 (Less Frequent) | EXPERIMENTAL | Participants received high dose MK-6194 at specified less frequent intervals |
| Placebo | PLACEBO_COMPARATOR | Participants received MK- 6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2 |
| Name | Type | Description |
|---|---|---|
| MK-6194 | BIOLOGICAL | Subcutaneous Administration |
| Placebo | BIOLOGICAL | Subcutaneous administration |
| MK-6194-matching placebo | DRUG | Subcutaneous injection |
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health * Has body mass index (BMI) within 18.0 to 28.0 kg/m\^2 (inclusive) and weight ≥50 kg Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * H...
MK-6194 is an investigational monoclonal antibody being studied for ulcerative colitis, atopic dermatitis, and in healthy volunteers. It is in Phase 1 clinical development and is not approved by the FDA. Studies have been completed in participants with active ulcerative colitis and atopic dermatitis, as well as in healthy adults.
MK-6194 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting Phase 1 clinical trials of this investigational monoclonal antibody across multiple countries, including the United States, for conditions such as ulcerative colitis and atopic dermatitis.
MK-6194 is in Phase 1 clinical development. Multiple Phase 1 trials have been completed, including studies in ulcerative colitis, atopic dermatitis, and healthy volunteers. As an investigational drug, it has not been approved by regulatory authorities and remains in early-stage clinical testing.
MK-6194 has completed several Phase 1 trials. NCT04924114 studied it in active ulcerative colitis with 57 participants. NCT05450198 examined multiple rising doses in atopic dermatitis with 72 participants. NCT06649877 and NCT06821334 evaluated it in healthy adults, including a Chinese participant study.
Yes, MK-6194 is also known as PT101. One clinical trial, NCT04924114, is titled "A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis." This alternative name may appear in research publications and trial registries.