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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. ...
Top 1 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150 |
XmAb7195 is an investigational monoclonal antibody being developed for allergic rhinitis and atopic disease. It has been studied in Phase 1 clinical trials in adult healthy volunteers and in adults with a history of allergic rhinitis, allergic conjunctivitis, or atopic dermatitis. It is not approved for any indication.
XmAb7195 targets immunoglobulin E, or IgE. IgE is the antibody class central to allergic responses, and XmAb7195 is designed as an anti-IgE monoclonal antibody. This target class places it among therapies aimed at reducing IgE-mediated allergic activity in conditions such as allergic rhinitis and atopic disease.
XmAb7195 is developed by Xencor, Inc., which trades on the Nasdaq under the ticker XNCR. Xencor is the sponsor of the clinical program for this monoclonal antibody candidate.
XmAb7195 is in Phase 1 clinical development. Both of its recorded Phase 1 trials have been completed, and the program has not advanced beyond that stage. XmAb7195 is investigational and has not been approved by the FDA for any indication.
XmAb7195 has been evaluated in two completed Phase 1 trials. NCT02148744 studied safety and tolerability in adult healthy volunteers and adults with allergic rhinitis, allergic conjunctivitis, or atopic dermatitis, enrolling 72 participants. NCT02881853 assessed safety, tolerability, and bioavailability of subcutaneously administered XmAb7195 in 57 participants. Both trials were conducted in the United States.
The XmAb7195 Phase 1 program enrolled 72 participants in NCT02148744 and 57 participants in NCT02881853. Both studies were randomized and double blind, and both enrolled adults aged 18 years and older in the United States.