In this study we will investigate how safe the experimental compounds AER001 and AER002 are and how well they are tolerated when they are used in healthy subjects.We also investigate how quickly and to what extent AER002 (as a single dose) and…
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Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the safety and tolerability of AER001 and AER002 in healthy
volunteers
Secondary outcome
- 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
Background summary
AER001 and AER002 are experimental compounds that may potentially be used for
the preventative treatment of coronavirus disease 2019 (COVID-19). AER001 and
AER002 are human antibodies that bind to the SARS-CoV 2 virus (coronavirus) in
a way that prevents it from entering human cells. Research has shown that the
combination of these antibodies can bind to all dominant coronavirus variants.
These antibodies could also be regarded as an extra layer of defense of the
body against future coronavirus infections.
Study objective
In this study we will investigate how safe the experimental compounds AER001
and AER002 are and how well they are tolerated when they are used in healthy
subjects.
We also investigate how quickly and to what extent AER002 (as a single dose)
and AER001 and AER002 (2 single sequential doses) are absorbed, transported,
and eliminated from the body. In addition, we look at whether the body has an
immune response to AER001 and AER002.
We compare the effects of AER001 and AER002 with the effects of a placebo.
AER001 and AER002 have not been used in humans before. They have been
extensively tested in the laboratory and on animals.
Study design
Part 1&2:
The study will take about 12 months from the screening visit until the end of
study visit.
Screening -> Day -21 up to Day -2
Treatment period Part 1 - Arrival -> Day -1
Treatment period Part 1 - In-house stay -> Day -1 up to Day 2
Treatment period Part 1 - Departure -> Day 2
Treatment period Part 1 - Follow-up visits* -> Day 8, 15, 29, 57, 85, 169, 223,
281
End of study visit -> Day 337
*If subjects received placebo, Day 85 is the last day they have to come to the
research center. They will be called on Days 169, 225, 281, and 337 to check
their health.
Part 3:
The study will take about 7,5 weeks from the screening visit until the end of
study visit.
Screening -> Day -21 up to Day -2
Treatment period - Arrival -> Day -1
Treatment period - In-house stay -> Day -1 up to Day 2
Treatment period - Departure -> Day 2
Treatment period - Follow-up visits* -> Day 8
End of study visit -> Between Day 28 and 30
Intervention
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 placebo (100, 300, 600 or 1200 mg).
Part 3: 2 intravenous infusions one right after each other, one with AER002 and
one with AER001 (300 or 1200 mg).
Study burden and risks
Blood draw
Drawing blood may be painful or cause some bruising. The use of the indwelling
cannula (a tube in a vein in the arm) can sometimes lead to inflammation,
swelling, hardening of the vein, blood clotting, and bleeding in the
environment (bruising) of the puncture site. In individuals, a fainting
reaction may be observed during blood draw, and this condition is presented as
pallor, nausea and sometimes vomiting, sweating, low heart rate, or drop in
blood pressure with dizziness or fainting.
In total, over the course of the study, we will take about Part 1 &2: 205
milliliters (mL) Part 3: 94 milliliters (mL) of blood from screening to end of
study visit. This amount does not typically cause any problems in adults. To
compare: a blood donation involves 500 mL of blood being taken each time. If
the investigator thinks it is necessary for the safety of a subject, extra
samples might be taken for possible additional testing. If this happens, the
total amount of blood drawn may be more than the amount indicated above.
Nasal sample collection
Nasal samples will be taken deep in the nose in one nostril using a flat
absorbent strip on Days 1, 8 and 29. The nasal test taker presses the tip of
the volunteers nose up with the thumb and holds the volunteers head with the
other fingers. After inserting the strip, hold a finger against the side of the
volunteers nostril for about 60 seconds. The volunteer must remove his finger
from the nostril before the strip is removed from the volunteers nose. The
nasal test may cause discomfort and can give an unpleasant feeling. The
volunteer may experience a stinging sensation and the volunteers eyes may
become watery. Nasal sensitivity may cause sneezing
Heart tracing
To make a heart tracing, electrodes (small, plastic patches) will be placed on
arms, chest and legs. Prolonged use of these electrodes can cause skin
irritation (rash and itching).
Coronavirus test
Samples for the coronavirus test will be taken from the back of the nose and
throat using swabs. Taking the samples only takes a few seconds, but can cause
discomfort and can give an unpleasant feeling. Taking a sample from the back of
the throat may cause subjects to gag. When the sample is taken from the back of
the nose, they may experience a stinging sensation and the eyes may become
watery.
888 Boylston Street Suite 1111
Boston MA 02199
US
888 Boylston Street Suite 1111
Boston MA 02199
US
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-001709-35-NL |
| CCMO | NL81586.056.22 |