Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XmAb7195 · 2 trials · 5 indications
Number, type and severity of adverse events, vital signs, electrocardiogram (ECGs), laboratory tests, and physical examinations will be reported during the study from randomization up to Day 43
Number, type and severity of adverse events, vital signs, electrocardiogram (ECGs), laboratory tests, and physical examinations will be reported during the study from randomization up to Day 36
| Arm | Type | Description |
|---|---|---|
| Part A1 | EXPERIMENTAL | XmAb7195 for IV infusion; dose level 1; 4 once-weekly doses |
| Part A2 | EXPERIMENTAL | XmAb7195 for SC injection; dose level 1; 4 once weekly doses |
| Part A3 | EXPERIMENTAL | XmAb7195 for SC injection; dose level 2; 4 once weekly doses |
| Part A4 | EXPERIMENTAL | XmAb7195 for SC injection; dose level 3; 4 once weekly doses |
| Part A5 | EXPERIMENTAL | XmAb7195 for SC injection; dose level 4; 4 once weekly doses |
| Part B6 | EXPERIMENTAL | XmAb7195 or placebo for SC injection; dose level 5; 4 once-weekly doses |
| Part B7 | EXPERIMENTAL | XmAb7195 or placebo for SC injection; dose level 6; 4 once-weekly doses |
| Part B8 | EXPERIMENTAL | XmAb7195 or placebo for SC injection; dose level 7; 4 once-weekly doses |
| Part B9 | EXPERIMENTAL | XmAb7195 or placebo for SC injection dose level 8; 4 once-weekly doses |
| XmAb7195 or Placebo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| XmAb7195 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: All Subjects: * Male or female between 18 to 60 years of age (inclusive at the time of screening). * Total body weight 50.0 to 100.0 kg, and body mass index (BMI) 19.0 to 35.0 kg/m2 (inclusive, at screening). * Women can be of either childbearing or non-childbearing potential. ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Polyrizon Ltd. | PLRZ | 1 | N/A | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |
XmAb7195 is an investigational monoclonal antibody being studied for allergic rhinitis, allergic conjunctivitis, and atopic dermatitis. It has been evaluated in healthy volunteers and in adults with a history of these allergic conditions. The drug is in Phase 1 clinical development and is not yet approved.
XmAb7195 is being developed by Xencor, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol XNCR. Xencor is conducting clinical trials of XmAb7195 in the United States.
XmAb7195 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one evaluating safety and tolerability in healthy volunteers and subjects with allergic conditions, and another assessing safety, tolerability, and bioavailability after subcutaneous administration. The drug remains investigational.
XmAb7195 has been studied in two completed Phase 1 trials. NCT02148744 evaluated safety and tolerability in 72 healthy volunteers and adults with allergic rhinitis, allergic conjunctivitis, or atopic dermatitis. NCT02881853 assessed safety, tolerability, and bioavailability in 57 healthy volunteers and subjects with atopic disease.
XmAb7195 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials in the United States. The trials focused on safety, tolerability, and bioavailability in healthy volunteers and subjects with allergic conditions, but the drug has not yet received regulatory approval.