Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ORG-129 · 1 trial · 1 indication
by assessing the number, severity and type of treatment emergent adverse events
by assessing the number, severity and type of treatment emergent adverse events
| Arm | Type | Description |
|---|---|---|
| ORG-129 | EXPERIMENTAL | Single ascending dose (up to 4 cohorts), Multiple ascending dose (up to 4 cohorts), Food interaction cohort, Multiple dose PK/PD cohort |
| Placebo | PLACEBO_COMPARATOR | Single ascending dose (up to 4 cohorts), Multiple ascending dose (up to 4 cohorts), Food interaction cohort, Multiple dose PK/PD cohort |
| Name | Type | Description |
|---|---|---|
| ORG-129 | DRUG | ORG-129 oral capsules |
| Placebo | DRUG | Placebo oral capsules |
Inclusion Criteria: To be included in the Single Dose Study, subjects should meet all the following criteria at the screening visit: 1. Healthy male subjects, 18-45 years (inclusive) of age at the time of enrolment. 2. Body weight within normal range (Quetelet's index between 19 and 27) expressed ...
ORG-129 is an investigational small molecule being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with a completed first-in-human trial. The drug is not approved and remains under investigation for its safety and tolerability in humans.
ORG-129 is being developed by AgomAb Therapeutics NV, a biopharmaceutical company. The company is conducting clinical trials for this investigational drug, which is currently in Phase 1 development.
ORG-129 is in Phase 1 clinical development. A first-in-human study has been completed, and the drug remains investigational. It is not approved for any use and is still undergoing clinical evaluation.
ORG-129 has one completed clinical trial, NCT04933565, titled 'First in Human Study of ORG-129 in Healthy Volunteers.' This Phase 1 study enrolled 81 participants in Spain and was a randomized, double-blind, placebo-controlled trial.
No, ORG-129 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has completed a first-in-human trial in healthy volunteers, but it has not received regulatory approval for any use.