Trials / Completed
CompletedNCT07473752
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
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Tonix Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TNX-1500 | The active ingredient is an anti-CD154 humanized IgG4 monoclonal antibody. |
| DRUG | Placebo: USP 0.9% sterile saline for injection | The placebo comparator arm (Arm 4) |
| BIOLOGICAL | Keyhole Limpet Hemocyanin (KLH) | 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 |
Timeline
- Start date
- 2023-07-18
- Primary completion
- 2024-02-22
- Completion
- 2024-02-22
- First posted
- 2026-03-16
- Last updated
- 2026-03-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07473752. Inclusion in this directory is not an endorsement.