Official Title
A Phase 1, First-In-Human, Open-label, Single Ascending Dose and Multidose Study to Assess the Safety, Reactogenicity, and Immunogenicity of the Adenovirus Vector SARS-CoV-2 Investigational Product SC-Ad6-1 Given Via Intramuscular, Intranasal or Inhaled Administration in Healthy Volunteers
Brief Summary

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

Detailed Description

Not Provided

Recruiting
COVID19

Biological: SC-Ad6-1

SC-Ad6-1, I.M., single or multiple-dose

Biological: SC-Ad6-1

SC-Ad6-1, I.N., single or multiple-dose

Biological: SC-Ad6-1

SC-Ad6-1, I.H., single or multiple-dose

Eligibility Criteria

Key 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

- Must have been fully vaccinated against COVID-19 and received last dose not less
than 3 months prior to Day 1 (High Dose #3 I.M. and I.N. booster arms only), not
less than 5 months prior to Day 1 (High Dose #4 I.N. booster arm only) and not less
than 12 months prior to Day 1 (I.H. booster arms and I.N or I.H. multiple dose
booster arms only)

Key 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 (non-booster arms only)

- 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 60 Years
Countries
Australia
Locations

Tetherex Study Site
Brisbane, Queensland, Australia

Contacts

Russell Rother, Ph.D.
855-222-0722
rrother@tetherex.com

Russell Rother, Ph.D., Study Director
Moat Biotechnology Corporation

Moat Biotechnology Corporation
NCT Number
MeSH Terms
COVID-19
Cloricromen