Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATH-1105 · 1 trial · 1 indication
Safety and tolerability of single or multiple ascending doses of ATH-1105 as measured by incidence of AEs, determined by clinical laboratory tests, physical examinations, vital signs measurements, and 12-lead ECG
Treatment-emergent adverse events will be graded on a 1 through 5 scale, based on severity as determined by the principal investigator.
| Arm | Type | Description |
|---|---|---|
| ATH-1105 | EXPERIMENTAL | Part A: ATH-1105 administered once as an oral solution. Part B: ATH-1105 administered once daily as an oral solution for 10 days. |
| Placebo | PLACEBO_COMPARATOR | Part A: Placebo administered once as an oral solution Part B: Placebo administered once daily as an oral solution |
| Name | Type | Description |
|---|---|---|
| ATH-1105 | DRUG | ATH-1105 in oral form. Participants will be administered ATH-1105 once in Part A and once daily for 10 days in Part B. |
| Placebo | DRUG | Placebo in oral form. Participants will be administered Placebo once in Part A and once daily for 10 days in Part B. |
Inclusion Criteria: * Body mass index between 18.0 and 32.0 kg/m2 inclusive. * In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and check-in or predose on Day 1 * Females wi...
ATH-1105 is an investigational small molecule being developed by LeonaBio, Inc. (ticker: LONA). It is currently in Phase 1 clinical development, studied in healthy volunteers. The drug is not approved and remains investigational.
ATH-1105 is being studied in healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics. It is in Phase 1 clinical development and is not yet approved for any medical condition.
ATH-1105 is being developed by LeonaBio, Inc., a biopharmaceutical company traded under the ticker LONA. The company is conducting Phase 1 clinical trials of this investigational small molecule.
ATH-1105 is in Phase 1 clinical development. A Phase 1 study has been completed, evaluating the drug in healthy volunteers. It is an investigational drug and has not been approved by regulatory authorities.
ATH-1105 has one completed Phase 1 clinical trial, NCT06432647, titled "A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105." The trial enrolled 80 healthy volunteers in the United States and was randomized, double-blind, and placebo-controlled.