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

Completed · Phase 1 · Has a placebo group

Conditions studied: Phase 1 First-in-human Study Involving Healthy Subjects

In brief

Key facts

Study ID: NCT07473752
Run by: Tonix Pharmaceuticals, Inc.
People needed: 26
Starts: 2023-07-18
Expected to finish: 2024-02-22
Last updated by the study team: 2026-03-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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
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

Where it is running

CTI Clinical Research Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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