COVID-19
Conditions
Interventions
Part 1: 1 single intravenous infusion of AER002 or placebo (100, 300, 600 or
1200 mg).
Part 2: 2 intravenous infusions one right after each other, one with AER002 or
placebo and one with AER001 or
Sponsors
Aerium Therapeutics
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects at least 18 years old and less than 50 years of age at first screening visit. 2. Subject has provided written informed consent prior to any trial-related procedure. 3. SARS-CoV-2 confirmed negative by RT-PCR in a nasopharyngeal, oropharyngeal, or respiratory sample at =50 kg.
Exclusion criteria
Exclusion criteria: 1. History of any clinically significant medical condition, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the subject by study participation. 2. History of any hospitalization (>24 hours) within 30 days of first screening visit. 3. History of infection with HIV, HCV and HBV. 4. History of alcohol or drug abuse as determined by the investigator. 5. History of any significant allergic reaction to prescription or non-prescription drugs or food, as determined by the investigator. 6. Female who is pregnant, lactating, breastfeeding or planning to become pregnant within 90 days after the last intake of IMP. 7. Participation in any clinical research study evaluating another investigational drug or device within 3 months of the first screening visit. 8. The use of other medications with the possibility for adverse reactions and/or difficulties in the interpretation of results, as determined by the investigator. 9. Subjects who have received a COVID-19 vaccine or a booster at least 2 weeks prior to screening or planning to receive the vaccine or the booster prior to Day 29 following the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of AER001 and AER002 in healthy volunteers | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the pharmacokinetics and pharmacodynamics of AER001 and AER002 - To assess the immunogenicity of AER001 and AER002 Exploratory objective - To assess the proportion of COVID-19 infections after Day 1. - To assess the penetration of AER001 and AER002 in the upper airway | — |
Countries
Netherlands
Outcome results
None listed