Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SL TNX-102 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, 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.
Every adverse events occurring during the study period will be reported.
| Arm | Type | Description |
|---|---|---|
| SL TNX-102 at 2.4 mg | EXPERIMENTAL | 1 x TNX-102 SL Tablets at 2.4 mg |
| SL TNX-102 at 4.8 mg | EXPERIMENTAL | 2 x TNX-102 SL Tablets at 2.4 mg |
| SL TNX-102-A at 2.4 mg | EXPERIMENTAL | 1 x TNX-102-A (without phosphate) SL Tablet at 2.4 mg |
| Cyclobenzaprine tablets | ACTIVE_COMPARATOR | 1 x 5 mg cyclobenzaprine oral tablet |
| Name | Type | Description |
|---|---|---|
| SL TNX-102 at 2.4 mg | DRUG | 1 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 mg | DRUG | 2 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 mg | DRUG | 1 TNX-102-A SL Tablet at 2.4 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 * 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...
TNX-102 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, and it is not yet approved by regulatory authorities.
TNX-102 at is being studied for use in healthy adults. It is currently in Phase 1 clinical development, meaning it is being evaluated for safety and pharmacokinetics in early-stage trials. The drug is not yet approved for any medical condition.
TNX-102 at is being developed by Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TNXP. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy adults.
TNX-102 at is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
TNX-102 at has one completed Phase 1 clinical trial, identified as NCT01689259. This trial was titled 'Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults' and enrolled 24 participants in Canada.
TNX-102 at is not the same as cyclobenzaprine. In a clinical trial, TNX-102 at was compared to cyclobenzaprine oral tablets to evaluate their pharmacokinetics and safety. TNX-102 at is a sublingual tablet formulation, while cyclobenzaprine is a separate oral medication.