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A Dose Finding Study for the Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens in Uninfected Healthy Subjects, COVID-19 Convalescent Subjects, and COVID-19 Vaccinated Subjects
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 of DTH reactions.
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 receive one intradermal injection (0.1 mL) of a positive control (CANDIN®), and one intradermal injection (0.1 mL) of a negative control "diluent".
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Clinical Site
Berlin, New Jersey, United States
Start Date
January 7, 2022
Primary Completion Date
September 17, 2022
Completion Date
September 17, 2022
Last Updated
November 6, 2024
9
ACTUAL participants
TNX-2110
BIOLOGICAL
TNX-2120
BIOLOGICAL
TNX-2130
BIOLOGICAL
CANDIN
BIOLOGICAL
Diluent
BIOLOGICAL
Lead Sponsor
Tonix Pharmaceuticals, Inc.
Collaborators
Data Source & Attribution
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