Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Viaskin PT · 1 trial · 1 indication
* Solicited AEs occurring from the time of each application through 14 days following Viaskin PT application; * Unsolicited AEs from the time of application through 28 days following the 1st application; * Serious Adverse Events from the time of the inform consent form signature through the final study visit of subject.
| Arm | Type | Description |
|---|---|---|
| Viaskin PT 25 mcg | EXPERIMENTAL | Viaskin PT 25 mcg |
| Viaskin PT 50 mcg | EXPERIMENTAL | Viaskin PT 50 mcg |
| Viaskin PT Placebo | PLACEBO_COMPARATOR | Viaskin PT Placebo |
| Name | Type | Description |
|---|---|---|
| Viaskin PT 25 mcg | BIOLOGICAL | Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14). |
| Viaskin PT 50 mcg | BIOLOGICAL | Two applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14). |
| Viaskin PT Placebo | BIOLOGICAL | Two applications of Viaskin PT Placebo at a 2-week interval (D0 and D14). |
| Boostrix™ | BIOLOGICAL | Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the optimal recall of their immunity against pertussis. |
Inclusion Criteria: * Has provided written informed consent before enrollment; * Adult male or female, ages 18 to 40 years (inclusive) at the time of enrollment; * Non-pregnant, non-lactating female; * Free of clinically significant health problems, as determined by pertinent medical history and cl...
Viaskin PT is an investigational product being developed for whooping cough, also known as pertussis. It is designed for use in adults, with the completed Phase 1 trial enrolling healthy volunteers aged 18 years and older. It has not been approved for any indication.
Viaskin PT is being developed by DBV Technologies S.A., a company whose shares trade under the ticker DBVT. DBV Technologies is the sponsor of the clinical program for this whooping cough candidate.
Viaskin PT is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The product remains investigational and has not been approved by the FDA or any other regulatory authority for whooping cough or any other indication.
Viaskin PT has been studied in one completed Phase 1 trial, NCT03035370, titled the Viaskin Pertussis Vaccine Trial. That randomized, double-blind, placebo-controlled study enrolled 102 healthy adult volunteers in Switzerland. No active trials of Viaskin PT are ongoing.