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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06205134 | Comparative Bioavailability of Intranasal Epinephrine | PHASE1 | COMPLETED | 12 | — | — | Aug 22, 2023 | Feb 5, 2024 | Jun 18, 2025 | 1 | Israel |
Plasma level of Epinephrine
Pharmacodynamic response
Pharmacodynamic response
Pharmacodynamic response
| Arm | Type | Description |
|---|---|---|
| 6 Healthy volunteers, sequence ABC | EXPERIMENTAL | Three drug administrations to each subject, each administration on a separate day. treatment order: A B C |
| 6 Healthy volunteers, sequence BAC | EXPERIMENTAL | Three drug administrations to each subject, each administration on a separate day. treatment order: B A C |
| Name | Type | Description |
|---|---|---|
| A: Epinephrine injection | DRUG | Autoinjector for intramuscular, single-use, 0.3mg |
| B: FMXIN002 3.6mg | DRUG | Nasus Pharma nasal powder spray 3.6 mg, single use in one nostril |
| C: FMXIN002 4.0mg | DRUG | Nasus Pharma nasal powder spray 4.0 mg, single use in one nostril |
Inclusion Criteria: * 1\) Non-smoking, male and female subjects from 18 to 55 years of age. 2) BMI ≥18 \< 30 kg/m2. 3) Females may be of childbearing or non-childbearing potential: * Childbearing potential: o Physically capable of becoming pregnant, must be willing to use acceptable effecti...