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-Fosgonimeton

Phase 1

Healthy Volunteers | Small molecule | Other |LeonaBio, Inc.|Last Updated: Dec 22, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05511558A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017)PHASE1 COMPLETED 8 — — Jul 13, 2022Oct 26, 2022Dec 22, 20221 United States
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Study Endpoints
Primary Endpoints
Mass balance of total radioactivity from [14C]-Fosgonimeton
Samples collected pre-dose.

Total radioactivity recovery (fet1-t2)

Routes/rates of elimination of [14C]-Fosgonimeton
Samples collected pre-dose.

Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces).

Maximum observed plasma concentration (Cmax) of ATH-1017/ATH-1001
Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.

Cmax will be determined from plasma samples.

Time to maximum observed plasma concentration (Tmax) of ATH-1017/ATH-1001
Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.

Tmax will be determined from plasma samples

Area under the plasma concentration time curve (AUC) for of ATH-1017/ATH-1001
Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.

AUC will be determined from plasma samples.

Half-life (t1/2) of ATH-1017/ATH-1001
Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.

t1/2 will be determined from plasma samples.

Secondary Endpoints
Quantitative metabolite profiles in plasma, urine, and feces after [14C]-Fosgonimeton administration
Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose
The chemical structure of major metabolites in plasma, urine, and feces after [14C]-Fosgonimeton administration
Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose
Incidence and severity of adverse events (safety and tolerability) of [14C]-Fosgonimeton when administered to healthy subjects
Samples collected pre-dose and at predetermined timepoints up to 17 days post-dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dosing GroupEXPERIMENTALAll 8 subjects will receive a single dose of study drug
Interventions
NameTypeDescription
[14C]-FosgonimetonDRUGCarbon-14 Radiolabeled Fosgonimeton
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Eligibility Criteria
Age Range18 Years — 60 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Males, of any race, between 18 and 60 years of age, inclusive. 2. Body mass index between 18.0 and 32.0 kg/m2, inclusive. 3. In good health, determined by the investigator's discretion 4. Subjects and their partners will agree to use contraception during their participation 5...

Countries:United States
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