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Also known as Cryptosporidium parvum oocysts (ABO809)
Cryptosporidium parvum oocysts · 2 trials · 2 indications
To determine the efficacy of EDI048 vs. placebo in healthy volunteers to reduce severity or resolve diarrhea.
Cryptosporidium infection was measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test. Up to 3 stool samples per day were collected, each separated by approximately 4-hour intervals, were analyzed by EIA for parasitological assessment of oocyst shedding.
| Arm | Type | Description |
|---|---|---|
| EDI048 | EXPERIMENTAL | Participants will receive ABO809 as a single oral dose. If participant is symptomatic, then he/she would be randomized to get EDI048 administered orally. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive ABO809 as a single oral dose. If participant is symptomatic, then he/she would be randomized to get placebo administered orally. |
| ABO809 | EXPERIMENTAL | Participants will receive ABO809 at a single oral dose of 1x10\^4 oocysts. Other doses such as 1x10\^6 oocysts may be considered to optimize the model |
| Name | Type | Description |
|---|---|---|
| Cryptosporidium parvum oocysts (ABO809) | BIOLOGICAL | ABO809 oral suspension, single dose |
| EDI048 | DRUG | EDI048 administered orally |
| Placebo | OTHER | Placebo administered orally |
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Ability to communicate well with the Investigator, and to understand and comply with the requirements of the study. * Male and female participants must be between 18 to 50 years of age and in good ...
Cryptosporidium parvum oocysts, also known as ABO809, is an investigational monoclonal antibody being developed for Cryptosporidium infection and cryptosporidiosis. It is currently in Phase 2 clinical development and is not yet approved by the FDA.
Cryptosporidium parvum oocysts is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being studied for its ability to treat Cryptosporidium infection and cryptosporidiosis.
Cryptosporidium parvum oocysts is being developed by Novartis AG, which trades under the ticker NVS. The drug is currently in Phase 2 clinical trials.
Cryptosporidium parvum oocysts is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 trial has been completed, and a Phase 2 trial is currently recruiting participants.
Cryptosporidium parvum oocysts has one completed Phase 1 trial (NCT05036668) and one recruiting Phase 2 trial (NCT07249463). The Phase 2 trial is testing the efficacy, safety, and tolerability of EDI048 in a Cryptosporidium infection model in healthy adults.
Yes, Cryptosporidium parvum oocysts is also known as ABO809. The drug is being studied under both names in clinical trials for cryptosporidiosis.