Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALPN-303 · 1 trial · 1 indication
Type, incidence, and severity of TEAE as assessed by CTCAE
| Arm | Type | Description |
|---|---|---|
| ALPN-303 Regimen A | EXPERIMENTAL | - |
| Placebo Regimen A | PLACEBO_COMPARATOR | - |
| ALPN-303 Regimen B | EXPERIMENTAL | - |
| Placebo Regimen B | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ALPN-303 | DRUG | Multiple dose levels will be evaluated. |
| Placebo | DRUG | Placebo will be administered |
Summary of Inclusion Criteria: * Able and willing to provide written informed consent * Body mass index 18 to 32 kg/m2 * Agree to avoid strenuous physical activity for 2 days prior to each study visit * Agree to use highly effective contraception during the study (all participants) and for 90 days ...
ALPN-303 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial in adult healthy volunteers. The drug is not approved for any condition and remains under investigation.
ALPN-303 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company is conducting clinical research on this investigational small molecule.
ALPN-303 is in Phase 1 clinical development. A Phase 1 study in adult healthy volunteers has been completed. The drug is investigational and has not been approved by regulatory authorities for any use.
ALPN-303 has one completed Phase 1 clinical trial, identified as NCT05034484, titled 'A Study of ALPN-303 in Adult Healthy Volunteers'. This randomized, double-blind, placebo-controlled study enrolled 72 participants in Australia.
ALPN-303 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A completed Phase 1 trial in healthy volunteers has been conducted, but the drug has not received regulatory approval for any indication.