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LTG-001 SDD

Phase 1

Pain Management | Small molecule | Pain |Latigo Biotherapeutics, Inc.|Trials Updated: Jan 14, 2026

LTG-001 SDD development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

LTG-001 SDD clinical trials

LTG-001 SDD · 1 trial · 1 indication

Phase 1 1
NCT07341152A Study Comparing LTG-001 SDD Formulation To LTG-001 Crystalline Immediate Release Tablets In Healthy ParticipantsPain Management
COMPLETED14 Analytics
PHASE1COMPLETED
A Study Comparing LTG-001 SDD Formulation To LTG-001 Crystalline Immediate Release Tablets In Healthy Participants
Pain Management
NCT0734115214
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Study Endpoints

Primary Endpoints

Determine the relative bioavailability of two different LTG-001 crystalline formulations (test) compared to the LTG-001 SDD formulation (reference) in the fasted state.
From enrollment to Period 4, Day 3 Discharge

results of LTG001 peak plasma concentration (Cmax)

Determine the relative bioavailability of two different LTG-001 crystalline formulations (test) compared to the LTG-001 SDD formulation (reference) in the fasted state
from enrollment to Period 4, Day 3 discharge

Results of LTG001 Area under the plasma concentration versus time curve, (AUC (0-last))

To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state.
From Enrollment to Period 4, Day 3 discharge

Results of Cmax

To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state
From enrollment to period 4, Day 3 Discharge

Results of Tmax

Secondary Endpoints

Secondary Objective
from enrollment to Follow up phone call
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Period 1 Regimen A SDD TabletEXPERIMENTAL -
Period 2 Regimen BEXPERIMENTAL -
Period 3 Regimen CEXPERIMENTAL -
Period 4 Regimen DEXPERIMENTAL -

Interventions

NameTypeDescription
LTG-001 SDDDRUGLTG-001
LTG-001 Formulation A Prototype 1DRUGLTG-001
LTG-001 Formulation B Prototype 2DRUGLTG-001
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures. * Must be willing and able to comply with all study requirements Aged 18 to 55 years inclusive at the time of signing informed consent. * Must agree to use an...

Countries:United States
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