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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Mar 2026

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At a glance

  • Drugs TNX 1500 (Primary) ; Keyhole limpet haemocyanin
  • Indications Autoimmune disorders; Graft-versus-host disease; Renal transplant rejection; Transplant rejection
  • Focus Adverse reactions; First in man
  • Sponsors Tonix Pharmaceuticals Inc

Most Recent Events

  • 14 Oct 2025 According to a Tonix Pharmaceuticals media release, presentation including data from this study was presented at the 61st Annual Congress of the Japan Society for Transplantation, which took place October 9-11, 2025, in Nagoya, Japan.
  • 14 Oct 2025 Status changed from recruiting to completed as per a Tonix Pharmaceuticals media release.
  • 06 Feb 2025 According to Tonix Pharmaceuticals media release, the company plans to discuss phase 1 trial results with the U.S. Food and Drug Administration (FDA) in an End-of-Phase 1 meeting.Pending alignment with the FDA, a Phase 2 study of TNX-1500 in kidney transplant recipients will be pursued.

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