A Phase 1 First-In-Human Study of the Investigational COVID-19 Vaccine SC-Ad6-1 in Healthy Volunteers

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    80
  • sponsor
    Tetherex Pharmaceuticals Corporation
Updated on 17 July 2021

Summary

This is a single-centre, open-label, first-in-human, single ascending dose and multiple dose study to assess the safety, reactogenicity, and immunogenicity of the SC-Ad6-1 investigational product when administered via the intramuscular (IM) or intranasal (IN) route in healthy volunteers.

Details
Condition COVID19
Treatment SC-Ad6-1
Clinical Study IdentifierNCT04839042
SponsorTetherex Pharmaceuticals Corporation
Last Modified on17 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult males and females, 18 to 60 years of age (inclusive)
Body mass index 18.0 and 32.0 kg/m2, with a body weight 50 kg at screening

Exclusion Criteria

History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease
History of chronic respiratory disorders including asthma, emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent (14 days prior to Screening) or ongoing respiratory tract infection
History of thrombosis (e.g., deep vein thrombosis, pulmonary embolism, etc.), any coagulation dysregulation disorder, or a history of thrombosis noted in immediate family members
History of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
Known previous infection with SARS-CoV-2 or presence of antibodies against SARS-CoV-2 or a positive SARS-CoV-2 PCR test
Any history of malignant disease 5 years prior to registration
History of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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