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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Tonix Pharmaceuticals, Inc.
Study ID
NCT07473752
Phase
PHASE1
Status
Completed

Conditions

  • Phase 1 First-in-human Study Involving Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • TNX-1500 — DRUG
    The active ingredient is an anti-CD154 humanized IgG4 monoclonal antibody.
  • Placebo: USP 0.9% sterile saline for injection — DRUG
    The placebo comparator arm (Arm 4)
  • Keyhole Limpet Hemocyanin (KLH) — BIOLOGICAL
    KLH is not the primary therapeutic drug being tested. Instead, it is an "immunogenic T-cell dependent antigen" used as a challenge tool to assess the pharmacological and immunosuppressant effects of TNX-1500

Study Details

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

Key Dates

Start date
Jul 18, 2023
Status verified
Mar 2026
Primary completion
Feb 22, 2024
Completion
Feb 22, 2024

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Arm 1: TNX-1500 3 mg/kg
  • Experimental: Arm 2: TNX-1500 10 mg/kg
  • Experimental: Arm 3: TNX-1500 30 mg/kg
  • Experimental: Arm 4: Placebo

Primary Outcome Measure

Nature, frequency, and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: From enrollment to the end of the study at Day 120 ]

Locations (1)

FacilityCityStateZIPSite coordinators
CTI Clinical Research CenterCincinnatiOhio45212-

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CTI Clinical Research Center· Cincinnati, OH