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ATH-1020

Phase 1

Undisclosed | Small molecule | Other |LeonaBio, Inc.|Trials Updated: Apr 8, 2024

ATH-1020 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2021

ATH-1020 target and mechanism

Molecular targetHGF
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

ATH-1020 clinical trials

ATH-1020 · 1 trial · 1 indication

Phase 1 1
NCT05169671Safety, Tolerability, and Pharmacokinetics Study of ATH-1020Healthy Volunteers
COMPLETED32 Analytics
PHASE1COMPLETED
Safety, Tolerability, and Pharmacokinetics Study of ATH-1020
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Study Endpoints

Primary Endpoints

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Up to 12 days post initial dosing (Part A); Up to 19 days post initial dosing (Part B)

Safety and tolerability of single or multiple ascending doses of ATH-1020 as measured by vital signs and clinical laboratory measurements.

Secondary Endpoints

Maximum observed plasma concentration (Cmax)
Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Time to maximum observed plasma concentration (Tmax)
Samples collected pre-dose and at predetermined timepoints within 48 hours post-dose.
Plasma concentration at the end of the dosing interval (Ctrough)
Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ATH-1020EXPERIMENTALATH-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).
PlaceboPLACEBO_COMPARATORPlacebo 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.

Interventions

NameTypeDescription
ATH-1020DRUGATH-1020 in oral capsule form
PlaceboDRUGPlacebo in oral capsule form
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Frequently asked questions about ATH-1020

What is ATH-1020?

ATH-1020 is an investigational small molecule developed by LeonaBio, Inc. It is a Phase 1 clinical-stage candidate studied in healthy adult volunteers in the United States. No approved indication has been disclosed for ATH-1020.

What does ATH-1020 target?

ATH-1020 targets HGF, also known as hepatocyte growth factor, a protein. HGF is a signaling protein, and ATH-1020 is a small molecule designed to act on this target. The specific therapeutic use being pursued has not been disclosed.

Who makes ATH-1020?

ATH-1020 is being developed by LeonaBio, Inc., which trades under the ticker LONA. LeonaBio is the sponsor of the clinical program for ATH-1020.

What phase is ATH-1020 in?

ATH-1020 is in Phase 1 development. It is an investigational drug and is not approved by the FDA. The Phase 1 program has completed one trial, and no trials are currently active.

What clinical trials is ATH-1020 in?

ATH-1020 has been studied in one completed Phase 1 trial, NCT05169671, titled Safety, Tolerability, and Pharmacokinetics Study of ATH-1020. The trial enrolled 32 healthy volunteers in the United States and was randomized, double-blind, and placebo-controlled.