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

NCT07473752 | Completed Phase 1 FDA Drug

• 1 other identifier: TNX-AC-KT101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Phase 1 First-in-human Study Involving Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Nature, frequency, and severity of treatment-emergent adverse events (TEAEs)

  From enrollment to the end of the study at Day 120

Secondary Outcomes (5)

• Cmax: maximum observed TNX-1500 serum concentration

  From enrollment to the end of the study at Day 120

• Tmax: time to maximum TNX-1500 serum concentration

  From enrollment to the end of the study at Day 120

• T1/2,z: Terminal exponential half-life, calculated as ln(2)/λz

  From enrollment to the end of the study at Day 120

• AUC0-t: Area under the TNX-1500 serum concentration-time curve calculated using linear trapezoidal rule from time zero to time t, where t is the time of the last observed quantifiable concentration (Ct)

  From enrollment to the end of the study at Day 120

• AUC0-∞: area under the TNX-1500 serum concentration-time curve from time zero to infinity, defined as AUC0-t + Ct/λz

  From enrollment to the end of the study at Day 120

Study Arms (4)

Arm 1: TNX-1500 3 mg/kg

EXPERIMENTAL

Drug: TNX-1500; Biological: Keyhole Limpet Hemocyanin (KLH)

Arm 2: TNX-1500 10 mg/kg

EXPERIMENTAL

Drug: TNX-1500; Biological: Keyhole Limpet Hemocyanin (KLH)

Arm 3: TNX-1500 30 mg/kg

EXPERIMENTAL

Drug: TNX-1500; Biological: Keyhole Limpet Hemocyanin (KLH)

Arm 4: Placebo

EXPERIMENTAL

Drug: Placebo: USP 0.9% sterile saline for injection; Biological: Keyhole Limpet Hemocyanin (KLH)

Interventions

Placebo: USP 0.9% sterile saline for injection DRUG

The placebo comparator arm (Arm 4)

Arm 4: Placebo

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

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

TNX-1500 DRUG

The active ingredient is an anti-CD154 humanized IgG4 monoclonal antibody.

Arm 1: TNX-1500 3 mg/kg; Arm 2: TNX-1500 10 mg/kg; Arm 3: TNX-1500 30 mg/kg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able to understand the key components of the study as described in the written informed consent document, and willing and able to provide written informed consent
• healthy male or female, 18 to 65 years of age, inclusive, at Screening
• body mass index (BMI) within the range of 18.5 to ≤34.9 kg/m2 at Screening
• if female, is surgically sterile, 1-year postmenopausal (confirmed by follicle stimulating hormone \[FSH\] at Screening), or, if of childbearing potential, is using a medically accepted method of contraception (the simultaneous use of 2 barrier methods, or the use of a non-hormonal intrauterine device \[IUD; in place at least 3 months prior to dosing\]) and agrees to continued use of this method until study Day 120
• if male, agrees to use an approved method of contraception (2 barrier methods, female partner's use of an IUD \[in place at least 3 months prior to dosing\], oral contraceptives, or female partner who is surgically sterile or 2 years postmenopausal) and agrees to use this method until study Day 120
• proof of receiving either Pfizer-BioNTech (COMIRNATY®) or Moderna (SPIKEVAXTM) coronavirus disease 2019 (COVID-19) vaccination ≥14 days prior to consent
• able to comply with all study procedures, including the Clinical Research Center COVID-19 policy and procedures, required overnight stay in the Clinical Research Center, and the food, beverage, and medication restrictions during the study
• in the opinion of the Investigator, is able to adhere to the requirements of the study.

You may not qualify if:

• history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, mAbs, or allergy to any of the TNX-1500 components
• history of shellfish allergy
• increased risk for thromboembolic events due to an ongoing heart disease or due to a medical device, including but not limited to vascular graft, valvular heart disease, atrial fibrillation, or a heart rhythm disorder
• use of any hormonal replacement therapy or oral, transdermal, IUD, or injectable hormonal contraception
• history of confirmed venous thromboembolism, arterial thrombosis, coagulopathy, or known platelet disorders
• history of diabetes, clinically significant and currently relevant cardiovascular, pulmonary, hepatic, or kidney diseases, as determined by the Investigator
• history of protein C or protein S deficiency disorders and/or clinically significant abnormality in protein C and protein S levels at Screening
• requiring treatment with antiplatelet and/or antithrombotic drugs
• received any doses of Janssen/Johnson \& Johnson COVID-19 vaccine
• history of major surgery in the last 6 months or plans to undergo elective surgery during the study period
• clinically significant abnormality upon physical examination at Screening, as determined by the Investigator
• use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening
• history of alcohol or illicit drug use disorder, marijuana use disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, or a reported habitual alcohol intake greater than 1.5 oz (ethanol equivalent) per day (eg, 24 oz of beer, 10 oz of wine, or 3 oz of hard liquor) for the past two years
• positive urine screen for drugs of abuse including but not limited to tetrahydrocannabinol, or elevated ethanol breathalyzer concentration on admission to the study center at Screening or at Check-in (Day -1)
• positive serologic test for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, human immunodeficiency virus

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead
• CTI Clinical Trial and Consulting Services, Inc.: collaborator

Study Sites (1)

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

MeSH Terms

Interventions

Injections; keyhole-limpet hemocyanin

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 16, 2026
• Study Start: July 18, 2023
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)