Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DR-5001 · 1 trial · 1 indication
For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort.
For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the per protocol cohort.
For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort; further, this outcome omitted ARD cases from Day 0-Day 10 because the protective effect of the vaccine was unlikely to take place during that time period.
ADV-7 seroconversion was defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) after study medication that represented at least a fourfold increase in titer from baseline (visit 0) in a subject whose baseline Type-7 titer was \<1:4.
| Arm | Type | Description |
|---|---|---|
| Vaccine | EXPERIMENTAL | Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0). |
| Placebo | PLACEBO_COMPARATOR | Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0). |
| Name | Type | Description |
|---|---|---|
| DR-5001 | BIOLOGICAL | All randomized subjects received a single tablet of both Type-4 and Type-7 ADV vaccines on Day 0. Both vaccine tablets were administered orally, kept in the mouth as briefly as possible and swallowed whole with water. Chewing the tablets was not permitted. |
| Placebo | OTHER | All randomized subjects received a single tablet each of the placebos matching Type-4 and Type-7 ADV vaccines on Day 0. Both placebo tablets were administered orally, kept in the mouth as briefly as possible and swallowed whole with water. Chewing the tablets was not permitted. |
Inclusion Criteria: * Military recruit in training * Male or female; if female, must be of non-childbearing potential or with a documented negative pregnancy test \</= 72 hours prior to study medication administration and agree not to become pregnant Exclusion Criteria: * Female nursing an infant...
DR-5001 is a monoclonal antibody being developed for the treatment of respiratory tract diseases. It is currently in Phase 3 clinical development and is being studied in a completed Phase 3 trial that evaluated its safety, efficacy, and immunogenicity in patients with respiratory tract diseases.
DR-5001 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being investigated for its potential to treat respiratory tract diseases, and its mechanism of action is not publicly detailed.
DR-5001 is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker symbol TEVA. The drug is currently in Phase 3 clinical development for respiratory tract diseases.
DR-5001 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 clinical trial for the drug has been completed, but it remains in clinical development.
DR-5001 has one completed Phase 3 clinical trial with the identifier NCT00382408. This trial evaluated the safety, efficacy, and immunogenicity of DR-5001 in 4,040 participants with respiratory tract diseases in the United States. The trial was randomized, double-blind, and placebo-controlled.
No alternative names for DR-5001 have been disclosed. The drug is known only by its development code DR-5001 and is being developed by Teva Pharmaceutical Industries Limited for respiratory tract diseases.