Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07228325 | Comparative PK/PD of FMXIN002 and EpiPen, in Healthy Adults With Allergic Rhinitis | PHASE1 | ENROLLING BY_INVITATION | 50 | — | — | Nov 3, 2025 | Apr 1, 2026 | Nov 14, 2025 | 1 | Canada |
Measurements in 14 timepoints
Time to maximum epinephrine level in plasma
Time to reach epinephrine level of 100pg/ml in plasma
Maximum epinephrine level in plasma
Total exposure to epinephrine
Pharmacodynamic response to epinephrine
Pharmacodynamic response to epinephrine
Pharmacodynamic response to epinephrine
| Arm | Type | Description |
|---|---|---|
| FMXIN002 Repeated doses in the same nostril | EXPERIMENTAL | Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart. |
| FMXIN002 Repeated doses in the opposite nostril | EXPERIMENTAL | Repeated doses of epinephrine nasal powder spray, in both nostrils, 10 minutes apart. |
| Name | Type | Description |
|---|---|---|
| FMXIN002 single dose | DRUG | Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions. |
| Epinephrine autoinjector single dose | DRUG | Epinephrine IM autoinjector 0.3mg |
| FMXIN002 single dose + NAC | DRUG | Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge (NAC) |
| Epinephrine autoinjector double dose | DRUG | Repeated doses of Epinephrine IM autoinjector 0.3mg, 10 minutes apart |
| FMXIN002 double dose | DRUG | Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions, 10 minutes apart. |
| FMXIN002 double dose + NAC | DRUG | Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge, 10 minutes apart. |
Inclusion Criteria: 1. Non-smoking, male and female participants, from 18 to 55 years of age. 2. Documented positive skin allergy test at screening. 3. History of hay fever, seasonal allergies, or allergic rhinitis during the last year. 4. BMI ≥18 and \< =30 kg/m2. 5. Females may be of childbearing...