drugset / Trial / NCT07473752
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TNX-1500 in Healthy Subjects
Phase 1
Completed
26 enrolled
Tonix Pharmaceuticals, Inc.
CTI Clinical Trial and Consulting Services · collab
RandomizedParallel-groupQuadruple-blindBasic science
Summary
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TNX-1500 in Healthy Subjects
Timeline
- Start
- 2023-07-18
- Primary completion
- 2024-02-22
- Completion
- 2024-02-22
Outcome
Met primary endpoint
release “All objectives were met and support proceeding to a Phase 2 trial.” tonixpharma.com ↗
release “TNX-1500 blocked the primary and secondary antibody responses to a test antigen at the 10 mg/kg and 30 mg/kg i.v. doses” tonixpharma.com ↗
release “TNX-1500 blocked the primary T cell–dependent antibody response to KLH at all doses” tonixpharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TNX-1500 | Monoclonal antibody | 3 mg/kg | — |
| Subject | TNX-1500 | Monoclonal antibody | 10 mg/kg | — |
| Subject | TNX-1500 | Monoclonal antibody | 30 mg/kg | — |
Indications
No indication recorded.