Phase 1 First-in-human Study Involving Healthy SubjectsPhase 1NCT07473752

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

A Phase 1 study testing TNX-1500 and Keyhole Limpet Hemocyanin (KLH) in people with Phase 1 First-in-human Study Involving Healthy Subjects, run by Tonix Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Phase 1 First-in-human Study Involving Healthy Subjects
What is being tested?: TNX-1500 and Keyhole Limpet Hemocyanin (KLH)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 18 Jul 2023to 22 Feb 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 29Show fewer

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
negative for EBV viral capsid antigen IgG, Epstein-Barr nuclear antigen IgG
history of positive tuberculin (TB) test or positive QuantiFERON® TB Gold at Screening
clinically significant abnormality on 12-lead ECG at Screening, as determined by the Investigator
clinically significant abnormal laboratory values (clinical chemistry, hematology, coagulation, or urinalysis) outside the reference values established by the laboratory, as determined by the Investigator at Screening or at Check-in (Day -1)
positive pregnancy test for women of childbearing potential (WOCBP) or lactating at Screening or at Check-in (Day -1)
participation in an investigational study within 30 days or within 5 half-lives of the investigational drug, whichever is longer, prior to the Screening Visit
receiving any antibody or biologic medicinal product within 90 days prior to Screening
unable to refrain from or anticipates the use of any prescription and/or non-prescription medications, vitamins, herbal, or dietary supplements beginning 14 days prior to the first dose of study medication and throughout the study, with the exception of occasional 'as-needed' use of acetaminophen at a dose of ≤1000 mg/day
COVID-19 infection within 28 days prior to Check-in (Day -1) and/or a positive test for severe acute respiratory syndrome coronavirus 2 antigen testing or equivalent testing at Check-in (Day -1)
previous exposure to KLH
history of vaccination (with the exception of COVID-19 vaccination) within 60 days prior to the Screening, or anticipated need for any type of vaccination(s) and/or boosters (including COVID-19 booster) throughout the study
history or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk.
abnormal renal function (FDA, 2020) (Appendix 2) based on an estimated glomerular filtration rate (eGFR; CKD-EPI 2021 equation) (National Kidney Foundation, 2021) < 60 mL/min at screening or at Check-in (Day -1).
moderate to severe hepatic impairment as per the Child-Pugh system (FDA, 2003) (Appendix 3). Exclude if Child-Pugh system score is > 6 points based on: encephalopathy grade; level of ascites; serum bilirubin, mg/dL; serum albumin, g/dL; and prothrombin time, sec prolonged. Note: elevated bilirubin due to Gilbert's syndrome is not exclusionary.

Trial locations and contacts

1 site in 1 country.

United States1 site

CTI Clinical Research Center
Cincinnati, Ohio, 45212

Other trials in United States

About this study

Conditions: Phase 1 First-in-human Study Involving Healthy Subjects
Being tested: TNX-1500, Placebo: USP 0.9% sterile saline for injection, Keyhole Limpet Hemocyanin (KLH)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TNX-1500Drug
The active ingredient is an anti-CD154 humanized IgG4 monoclonal antibody.
Placebo: USP 0.9% sterile saline for injectionDrug
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 groups in NCT07473752
Study group	Role	What they receive
Arm 1: TNX-1500 3 mg/kg	Experimental	Not described Receives: Drug: TNX-1500; Biological: Keyhole Limpet Hemocyanin (KLH)
Arm 2: TNX-1500 10 mg/kg	Experimental	Not described Receives: Drug: TNX-1500; Biological: Keyhole Limpet Hemocyanin (KLH)
Arm 3: TNX-1500 30 mg/kg	Experimental	Not described Receives: Drug: TNX-1500; Biological: Keyhole Limpet Hemocyanin (KLH)
Arm 4: Placebo	Experimental	Not described Receives: Drug: Placebo: USP 0.9% sterile saline for injection; Biological: Keyhole Limpet Hemocyanin (KLH)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

Cmax: maximum observed TNX-1500 serum concentration
Measured: From enrollment to the end of the study at Day 120
Tmax: time to maximum TNX-1500 serum concentration
Measured: From enrollment to the end of the study at Day 120
T1/2,z: Terminal exponential half-life, calculated as ln(2)/λz
Measured: 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)
Measured: 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
Measured: From enrollment to the end of the study at Day 120

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jul 202322 Feb 2024

First posted16 Mar 2026
Study start18 Jul 2023
Primary completion22 Feb 2024
Study completion22 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Phase 1 First-in-human Study Involving Healthy SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07473752
Sponsor's protocol ID: TNX-AC-KT101
Status last verified: Mar 2026
First submitted: 10 Mar 2026
Last updated: 16 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07473752
Acronym / sponsor ID: TNX-AC-KT101
Conditions: Phase 1 First-in-human Study Involving Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: CTI Clinical Trial and Consulting Services
Study start: 18 Jul 2023 (actual)
Primary completion: 22 Feb 2024 (actual)
Study completion: 22 Feb 2024 (actual)
First posted: 16 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
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)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (29 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TNX-1500The active ingredient is an anti-CD154 humanized IgG4 monoclonal antibody.	Drug	Arm 1: TNX-1500 3 mg/kg, Arm 2: TNX-1500 10 mg/kg, Arm 3: TNX-1500 30 mg/kg
Placebo: USP 0.9% sterile saline for injectionThe placebo comparator arm (Arm 4)	Drug	Arm 4: Placebo
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	Biological	Arm 1: TNX-1500 3 mg/kg, Arm 2: TNX-1500 10 mg/kg, Arm 3: TNX-1500 30 mg/kg, Arm 4: Placebo

Primary outcome

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

5 secondary outcomes

Cmax: maximum observed TNX-1500 serum concentration
Time frame: From enrollment to the end of the study at Day 120
Tmax: time to maximum TNX-1500 serum concentration
Time frame: From enrollment to the end of the study at Day 120
T1/2,z: Terminal exponential half-life, calculated as ln(2)/λz
Time frame: 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)
Time frame: 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
Time frame: From enrollment to the end of the study at Day 120

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07473752.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.