Approval Probability
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RDN-929 · 1 trial · 1 indication
Listing and summary of AE incidence
Listing of clinically significant changes in PE findings
Listing and change from baseline to end of study
Listing and change from baseline to end of study
Listing and change from baseline to end of study
Change in 12-lead ECG parameters from baseline to end of study
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VAS for headache and nausea
| Arm | Type | Description |
|---|---|---|
| Cohort 1:1 - 1:6 RDN-929 | EXPERIMENTAL | RDN-929 single dose capsule |
| Cohort 1:1 - 1:6 placebo | PLACEBO_COMPARATOR | Placebo single dose capsule |
| Cohort 2:1 | EXPERIMENTAL | Fed/Fast RDN-929 |
| Cohort 3:1- 3:4 RDN-929 | EXPERIMENTAL | RDN-929 multiple dose capsules once daily for 12 days |
| Cohort 3:1- 3:4 placebo | PLACEBO_COMPARATOR | placebo multiple dose capsules once daily for 10 days |
| Name | Type | Description |
|---|---|---|
| RDN-929 | DRUG | Single dose from 2 mg to TBD |
| Placebo oral capsule | DRUG | Matching placebo Single dose |
| RDN-929 TBD dose | DRUG | Fed vs fast dose TBD based upon results of previous cohorts |
Inclusion Criteria: * Healthy as determined by the Investigator, based on a medical evaluation including medical history physical examination, neurological examination, laboratory tests and cardiac monitoring * Men, age 18-54 years inclusive at Screening (Part 1) or men and postmenopausal or surgic...
RDN-929 is an investigational small molecule being developed by Alkermes plc (NASDAQ: ALKS). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic area is classified as Other.
The molecular target of RDN-929 has not been disclosed in available information. As such, its mechanism of action is not publicly specified. The drug is a small molecule in early-stage clinical development.
RDN-929 is being developed by Alkermes plc, a biopharmaceutical company traded on NASDAQ under the ticker ALKS. The company is conducting clinical trials for this investigational drug.
RDN-929 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is still in early-stage clinical trials.
RDN-929 has one completed Phase 1 trial, NCT03668314, titled "Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects." This trial enrolled 84 healthy participants in the Netherlands and was a randomized, double-blind, placebo-controlled study.
No alternative names for RDN-929 have been disclosed. The drug is identified solely by its code name RDN-929 in clinical trial registries and company communications.