Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TNX-102 SL at · 1 trial · 1 indication
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, and 48 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 and 24-48 hours post-dose.
Every adverse events occurring during the study period will be reported.
| Arm | Type | Description |
|---|---|---|
| TNX-102 SL Tablets at 2.8 mg | EXPERIMENTAL | 1 x TNX-102 SL Tablets (with potassium phosphate) at 2.8 mg |
| TNX-102-B SL Tablets at 2.8 mg | EXPERIMENTAL | 1 x TNX-102-B SL Tablets (with sodium phosphate) at 2.8 mg |
| TNX-102-C SL Tablets at 2.8 mg | EXPERIMENTAL | 1 x TNX-102-C SL Tablets (with trisodium citrate) at 2.8 mg |
| Cyclobenzaprine tablets | ACTIVE_COMPARATOR | 1 x 5 mg cyclobenzaprine oral tablet |
| Name | Type | Description |
|---|---|---|
| TNX-102 SL Tablets at 2.8 mg | DRUG | 1 x TNX-102 SL Tablet (with potassium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it. |
| TNX-102-B SL Tablets at 2.8 mg | DRUG | 1 x TNX-102-B SL Tablet (with sodium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it. |
| TNX-102-C SL Tablets at 2.8 mg | DRUG | 1 x TNX-102-C SL Tablet (with trisodium citrate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it. |
| Cyclobenzaprine tablets | DRUG | 1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water |
Inclusion Criteria: * Healthy adults * Male or female * 18-65 years old * Non-smoker * 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...
TNX-102 SL at is an investigational small molecule being developed by Tonix Pharmaceuticals Holding Corp. (TNXP). It is currently in Phase 1 clinical development. The drug is being studied in healthy adults, with one completed clinical trial evaluating its pharmacokinetics and safety.
TNX-102 SL at is being studied for use in healthy adults. The completed Phase 1 trial assessed the comparative pharmacokinetics and safety of different formulations of TNX-102 SL tablets and cyclobenzaprine tablets in healthy adult participants. No specific disease indication has been reported for this drug.
TNX-102 SL at is being developed by Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company listed on the NASDAQ under the ticker symbol TNXP. The company is conducting clinical research on this investigational small molecule drug.
TNX-102 SL at is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials currently ongoing. The drug remains investigational and has not been approved by regulatory authorities.
TNX-102 SL at has one completed clinical trial, identified as NCT01889173. This Phase 1 study, titled 'Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults,' enrolled 24 participants in Canada.
TNX-102 SL at is not the same as cyclobenzaprine. In the completed clinical trial, TNX-102 SL tablets were compared against cyclobenzaprine 5 mg oral tablets as an active control. TNX-102 SL at is a distinct investigational drug being developed by Tonix Pharmaceuticals.