A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study To Assess The Safety, Tolerability, Pharmacokinetics Of Two Monoclonal Antibodies In Healthy Volunteers

Completed

Conditions: COVID-19
10047438

Registration Number: NL-OMON51340

Lead Sponsor: Aerium Therapeutics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

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 <= 72 hours before randomization and administration of
IMP or placebo on Day 1 (all efforts should be made to complete this test as
close as possible to Day 1).
4. Subject is in good health and stable medical condition based on medical
history, physical examination, laboratory findings, vital signs and ECG (as
assessed by the investigator within 21 days prior to Day 1).
5. Willingness and ability to comply with the protocol.
6. For female subject of childbearing potential with a fertile male sexual
partner: the use of an adequate contraception from at least 4 weeks prior to
the first administration of the IMPs until 90 days after the last intake of the
IMP. Male subjects must agree to use adequate contraception from the first
administration of the IMP until 90 days after the last intake of the IMP.
7. BMI of 18.0 to 32.0 kg/m2, inclusive, at screening.
8. Weight: >=50 kg.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the safety and tolerability of AER001 and AER002 in healthy<br /><br>volunteers</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess the pharmacokinetics and pharmacodynamics of AER001 and AER002<br /><br>- To assess the immunogenicity of AER001 and AER002<br /><br><br /><br>Exploratory objective<br /><br>- To assess the proportion of COVID-19 infections after Day 1.<br /><br>- To assess the penetration of AER001 and AER002 in the upper airway</p><br>