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AL-794

Phase 1

Influenza | Small Molecules | Infectious Disease |Johnson & Johnson|Trials Updated: Feb 3, 2025

AL-794 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Jan 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment251

FDA Designations

No designations recorded

AL-794 clinical trials

AL-794 · 3 trials · 2 indications

Phase 1 3
NCT02877160A Study to Assess the PK of AL-794 Formulations in Healthy SubjectsInfluenza
COMPLETED31 Analytics
NCT02888327A Drug-Drug Interaction Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir and JNJ-63623872Influenza in Humans
COMPLETED68 Analytics
NCT02588521A Study of AL-794 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses, and the Antiviral Activity of Multiple Doses in an Influenza Challenge StudyInfluenza
COMPLETED152 Analytics
PHASE1COMPLETED
A Study to Assess the PK of AL-794 Formulations in Healthy Subjects
Influenza
NCT0287716031
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PHASE1COMPLETED
A Drug-Drug Interaction Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir and JNJ-63623872
Influenza in Humans
NCT0288832768
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PHASE1COMPLETED
A Study of AL-794 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses, and the Antiviral Activity of Multiple Doses in an Influenza Challenge Study
Influenza
NCT02588521152
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Study Endpoints

Primary Endpoints

Area under the concentration-time curve from time of dosing to infinity (AUC0-inf) of ALS-033719 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions.
From Day 1 (Prior to dosing) to Day 14
Maximum observed plasma concentration (Cmax) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872
Area under plasma concentration-time curve from time 0 to dosing interval (tau) (AUC0-τ) for ALS-033719 and ALS-033927, oseltamivir, oseltamivir carboxylate, and JNJ-63623872
At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872
Area under plasma concentration-time curve from time 0 to last measurable plasma concentration (AUClast) for digoxin, midazolam 1'-OH-midazolam, and pitavastatin
At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Maximum observed plasma concentration (Cmax) for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Safety Data including but not limited to tabulation of adverse events, physical exam, vital signs, 12-lead ECGs and clinical lab results
Screening to Day 8 in Single Dose and Food Effect portions of the study

Safety data including but not limited to tabulation of adverse events, physical exam, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urinalysis). Note that in the Multiple Ascending Dose (MAD) portion of the study, the time frame is from Screening to Day 17 (MAD) and for the Viral Challenge portion of the study the time frame is from Screening to Day 28 (Viral Challenge).

Secondary Endpoints

Safety as determined by AEs
From screening to Day 14
Safety as determined by Clinical lab results
From screening to Day 14
Safety as determined by 12-lead ECGs
From screening to Day 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Reference Formulation FastedEXPERIMENTAL150 mg of AL-794 study drug in suspension dosed in a fasted condition
Test Formulation FastedEXPERIMENTAL150 mg of AL-794 tablet formulation (3 x 50 mg tabs) dosed in a fasted condition
Test Formulation FedEXPERIMENTAL150 mg of AL-794 tablet formulation (3 x 50 mg tabs) dosed in a fed condition
Oseltamivir and AL-794OTHEROseltamivir alone and with AL-794 over fourteen days.
Digoxin, Midazolam, and AL-794OTHERSingle doses of Digoxin and Midazolam with and without AL-794 over seventeen days.
Pitavastatin and AL-794OTHERSingle doses of Pitavastatin with and without AL-794 over seventeen days.
JNJ-63623872 and AL-794OTHERJNJ-63623872 alone and with AL-794 over fourteen days.
AL-794EXPERIMENTALAL-794 administered orally in a suspension
VehiclePLACEBO_COMPARATORSuspension vehicle alone

Interventions

NameTypeDescription
AL-794 suspensionDRUG -
AL-794 tabletDRUG -
AL-794DRUG -
OseltamivirDRUG -
DigoxinDRUG -
MidazolamDRUG -
PitavastatinDRUG -
JNJ-63623872DRUG -
Placebo/VehicleOTHERSuspension vehicle without active drug
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subject has provided written consent. 2. In the investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned. 3. Subject is in good health as deem...

Countries:United Kingdom
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Competitive Landscape -Influenza 35 trials

Top 8 of 11 competitors

CompanyTickerTrialsLead PhaseDrugs
GSK plc Sponsored ADRGSK3PHASE3mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine
Moderna, Inc.MRNA2PHASE3mRNA-1018-H5, mRNA-1010, Fluarix Trivalent
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
Sanofi SA Sponsored ADRSNY4PHASE1H5N8 pandemic influenza vaccine (adjuvanted)
Hoffmann-La RocheRHHBY2PHASE3Baloxavir Marboxil
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sinovac Biotech Ltd.SVA1PHASE1Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine
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