Status:
TERMINATED
Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens
Lead Sponsor:
Tonix Pharmaceuticals, Inc.
Collaborating Sponsors:
Premier Research
Conditions:
Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This dose finding, multi-cohort study is designed to evaluate the safety and efficacy of intradermally-injectedTNX-2100, synthesized SARS-CoV-2 peptide antigens and assess the presence and magnitude o...
Detailed Description
Three IPs (TNX-2110, TNX- 2120, TNX-2130) will be administered by intradermal injection (0.1 mL) in two concentration strengths (Stage 1: "1:10 dilution" and Stage 2: "undiluted"). Subjects will also ...
Eligibility Criteria
Inclusion
- Male or female subjects aged 18 - 65 years of age, inclusive, in good general health as determined by medical evaluation Subject receives a negativeSARS-CoV-2 PCR test result at their screening or baseline visit
Exclusion
- Subjects will be excluded if they have clinically significant underlying conditions associated with high risk for severe COVID-19 infections as identified by the Centers for Disease Control and Prevention (CDC) (Appendix 2). These conditions include, but are not limited to: chronic obstructive pulmonary disease, diabetes mellitus (Type 1 and 2), obesity, hypertension, heart disease, and cerebrovascular disease.
Key Trial Info
Start Date :
January 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05216510
Start Date
January 7 2022
End Date
September 17 2022
Last Update
November 6 2024
Active Locations (1)
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1
Clinical Site
Berlin, New Jersey, United States, 08009