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SL TNX-102 at

Phase 1

Healthy Adults | Small molecule | Other |Tonix Pharmaceuticals Holding Corp.|Last Updated: Sep 26, 2014

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01689259Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy AdultsPHASE1 COMPLETED 24 — — Sep 1, 2012Mar 1, 2014Sep 26, 20141 Canada
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Study Endpoints
Primary Endpoints
Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urine
27 time points per period for blood assessment ; 3 pooled analyses in urine.

Blood samples will be taken per period: within 30 minutes pre-dose and 2, 3.5, 5, 10, 20, 30, and 45 minutes and 1, 2, 2.5, 3, 3.33, 3.67, 4, 4.33, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose. A single urine sample will be collected within 30 minutes pre-dose (one sample), and urine will be pooled from 0-24, 24-48 and 48-72 hours post-dose.

Safety and tolerability of TNX-102 SL Tablets at 2.4 mg and 4.8 mg.
Continuously until the end (day 4) of the study period + Telephone follow-up 7-13 days after dosing (total duration: about 1 month)

Every adverse events occurring during the study period will be reported.

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SL TNX-102 at 2.4 mgEXPERIMENTAL1 x TNX-102 SL Tablets at 2.4 mg
SL TNX-102 at 4.8 mgEXPERIMENTAL2 x TNX-102 SL Tablets at 2.4 mg
SL TNX-102-A at 2.4 mgEXPERIMENTAL1 x TNX-102-A (without phosphate) SL Tablet at 2.4 mg
Cyclobenzaprine tabletsACTIVE_COMPARATOR1 x 5 mg cyclobenzaprine oral tablet
Interventions
NameTypeDescription
SL TNX-102 at 2.4 mgDRUG1 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it.
SL TNX-102 at 4.8 mgDRUG2 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing them.
SL TNX-102-A at 2.4 mgDRUG1 TNX-102-A SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it.
Cyclobenzaprine tabletsDRUG1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adults * Male or female * Non-smoker * 18-65 years old * BMI \> 18.5 and \< 30.0 * With medically acceptable form of contraception (female only) * With signed informed consent Exclusion Criteria: * Any clinically significant abnormality including ECG abnormalities or...

Countries:Canada
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