Approval Probability
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ATH-1020 · 1 trial · 1 indication
Safety and tolerability of single or multiple ascending doses of ATH-1020 as measured by vital signs and clinical laboratory measurements.
| Arm | Type | Description |
|---|---|---|
| ATH-1020 | EXPERIMENTAL | ATH-1020 in oral form. Participants in the single ascending dose cohort (Cohort A) will receive a single dose of ATH-1020. Participants in the multiple ascending dose cohort (Cohort B) will receive up to nine doses of ATH-1020 (up to 4 for cohort B5). |
| Placebo | PLACEBO_COMPARATOR | Placebo in oral form. Participants in the single ascending dose cohort (Cohort A) will receive a single dose of Placebo. Participants in the multiple ascending dose cohort (Cohort B) will receive up to nine doses of placebo. |
| Name | Type | Description |
|---|---|---|
| ATH-1020 | DRUG | ATH-1020 in oral capsule form |
| Placebo | DRUG | Placebo in oral capsule form |
Inclusion Criteria: All Subjects 1. Body mass index (BMI) of ≥ 18.0 and ≤ 32.0 kg/m2 at Screening, with minimum weight of 60 kg. 2. Subjects in generally good health per the investigator's discretion. 3. Male subjects and their partners must be willing to comply with the contraceptive requirements...
ATH-1020 is an investigational small molecule being developed by LeonaBio, Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics. It is not approved by the FDA and remains in clinical development.
ATH-1020 is being studied for use in healthy volunteers. The Phase 1 clinical trial was designed to assess the safety, tolerability, and pharmacokinetics of the drug. It is not yet approved for any medical condition and is in early-stage clinical development.
ATH-1020 is developed by LeonaBio, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and tolerability. LeonaBio, Inc. is the sponsor of the Phase 1 study of ATH-1020.
ATH-1020 is in Phase 1 clinical development. A Phase 1 study has been completed, which involved 32 healthy volunteers. The drug is investigational and has not been approved by regulatory authorities. Further clinical development may be required to assess its safety and efficacy.
ATH-1020 has one completed Phase 1 clinical trial, identified as NCT05169671. This study was a randomized, double-blind, placebo-controlled trial conducted in the United States with 32 healthy volunteers. The trial evaluated the safety, tolerability, and pharmacokinetics of ATH-1020.
ATH-1020 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial assessed safety and tolerability in healthy volunteers, but the drug has not received regulatory approval for any use.