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 developed by LeonaBio, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. The specific disease or condition it is intended to treat has not been disclosed.
ATH-1105 is being developed by LeonaBio, Inc., which trades under the ticker LONA. LeonaBio sponsored the Phase 1 study of ATH-1105 conducted in the United States.
ATH-1105 is in Phase 1 clinical development. Its single Phase 1 trial, NCT06432647, has been completed. The program has not advanced beyond Phase 1 based on the available information, and no later-stage trials are listed.
ATH-1105 has been evaluated in one clinical trial, NCT06432647, titled a single ascending dose and multiple ascending dose study of the safety, tolerability, and pharmacokinetics of ATH-1105. The Phase 1 trial enrolled 80 healthy volunteers in the United States and is completed.
Yes. The Phase 1 trial of ATH-1105, NCT06432647, was randomized, double blind, and placebo controlled. It enrolled 80 healthy adult volunteers of all sexes, aged 18 years and older, in the United States, and evaluated safety, tolerability, and pharmacokinetics.