Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pelacarsen · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SAD: Placebo | PLACEBO_COMPARATOR | Single dose of Pelacarsen-matching placebo administered by SC injection on Day 1 of single-dose treatment period. |
| SAD: Pelacarsen 20 milligrams (mg) | EXPERIMENTAL | Single dose of Pelacarsen, 20 mg, administered by SC injection on Day 1 of single-dose treatment period. |
| SAD: Pelacarsen 40 mg | EXPERIMENTAL | Single dose of Pelacarsen, 40 mg, administered by SC injection on Day 1 of single-dose treatment period. |
| SAD: Pelacarsen 80 mg | EXPERIMENTAL | Single dose of Pelacarsen, 80 mg, administered by SC injection on Day 1 of single-dose treatment period. |
| MD: Placebo | PLACEBO_COMPARATOR | Multiple doses of Pelacarsen-matching placebo administered by SC injection every 4 weeks, on Days 1, 29, 57 and 85 of multiple-dose treatment period. |
| MD: Pelacarsen 80 mg | EXPERIMENTAL | Multiple doses of Pelacarsen, 80 mg, administered by SC injection every 4 weeks, on Days 1, 29, 57 and 85 of multiple-dose treatment period. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Pelacarsen-matching placebo administered by SC injection. |
| Pelacarsen | DRUG | Pelacarsen administered by SC injection. |
Inclusion Criteria: 1. Provided written informed consent (signed and dated) and any authorizations required by local law and was able to comply with all study requirements. 2. Male and female of first-, second- or third-generation Japanese participants. 3. Japanese healthy or obese male and female ...
Pelacarsen is an investigational small molecule being studied in healthy participants. It is being evaluated in a Phase 1 clinical trial to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is not approved for any indication and remains in clinical development.
Pelacarsen is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical research on this investigational drug.
Pelacarsen is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed, and the drug is still in the early stages of clinical research.
Pelacarsen has been studied in one completed Phase 1 clinical trial, identified as NCT05337878. This trial assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of Pelacarsen in healthy Japanese participants. The study enrolled 29 participants and was conducted in the United States.
Pelacarsen is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial focused on healthy participants, and the drug has not yet progressed to later-stage trials or regulatory approval.