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 developed by AgomAb Therapeutics NV. It has been studied in a first-in-human Phase 1 trial in healthy volunteers. The specific disease indications for which ORG-129 is being developed have not been disclosed.
ORG-129 is being developed by AgomAb Therapeutics NV, which trades under the ticker AGMB. The company sponsored the first-in-human study of the compound in healthy volunteers.
ORG-129 is in Phase 1 development. A single first-in-human Phase 1 study has been completed, and no active trials are currently listed. The drug remains investigational and is not approved for any indication.
ORG-129 has been evaluated in one clinical trial, NCT04933565, titled First in Human Study of ORG-129 in Healthy Volunteers. The Phase 1 trial was completed in Spain and enrolled 81 healthy adult participants of all sexes aged 18 years and older.
The Phase 1 trial of ORG-129, NCT04933565, was a randomized, double-blind, placebo-controlled study conducted in healthy volunteers. It enrolled 81 participants in Spain and has been completed. The study was not biomarker-selected.