A Phase I, Randomized, Placebo-controlled, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen® (Poly I:Poly C12U) in Healthy Subjects
- Conditions
- CoronaCOVID-19SARS-CoV-210047438
- Registration Number
- NL-OMON50834
- Lead Sponsor
- AIM ImmunoTech Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1. Signed informed consent prior to any study-mandated procedure;
2. Male or female subjects, 18 to 70 years of age, inclusive at screening;
3. Body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening, and
with a minimum weight of 50 kg.
4. Participant must be healthy, in the investigator*s clinical judgment, as
confirmed by medical history, physical examination, vital signs, ECG and
laboratory assessments performed at screening. Repeated laboratory testing may
be performed at the discretion of the clinical investigators for spurious
results on a case by case basis;
5. Willing to comply with effective contraception during the study if subject
is male or women of child bearing potential, up to 90 days after the last dose
of study treatment.
6. Has the ability to communicate well with the investigator in the Dutch
language and willing to comply with the study restrictions
1. Evidence of any active or chronic disease or condition that could interfere
with, or for which the treatment of might interfere with, the conduct of the
study, or that would pose an unacceptable risk to the subject in the opinion of
the investigator (following a detailed medical history, physical examination,
vital signs (systolic and diastolic blood pressure, pulse rate, body
temperature) and 12-lead electrocardiogram (ECG). Minor deviations from the
normal range may be accepted, if judged by the Investigator to have no clinical
relevance;
2. Clinically significant abnormalities, as judged by the investigator, in
laboratory test results (including hepatic and renal panels, complete blood
count, chemistry panel and urinalysis. In the case of uncertain or questionable
results, tests performed during screening may be repeated before randomization
to confirm eligibility or judged to be clinically irrelevant for healthy
subjects;
3. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV ab),
or human immunodeficiency virus antibody (HIV ab) at screening;
4. Respiratory tract infection (including flu and common cold symptoms) or any
febrile illness (>38°celsius) in the period of 3 days before first treatment
administration;
5. Presence of respiratory viral infection as determined by respiratory panel
on nasal swab at baseline (including positive SARS-CoV-2 PCR test);
6. History of chronic respiratory diseases (e.g. chronic obstructive pulmonary
disease, emphysema, chronic rhinitis or sinusitis, asthma or other reactive
airway diseases) in adulthood. Childhood asthma and non-active allergic
rhinitis (including hay fever) will be permitted at the discretion of the
investigator;
7. History of frequent nose bleeds;
8. Significant anatomical nasal abnormalities or other nasal abnormalities that
might impact the study executions (including, but not limited to, nasal septal
defects, cleft palate, nasal polyps, previous nasal cautery or surgery that
impacts study assessments);
9. Immunocompromised (known or expected immune deficiency, disease, or use of
medication that may affect the immune system) or evidence of autoimmune
disorder (deemed clinically relevant by the investigator);
10. Participation in an investigational drug or device study (last dosing of
previous study was within 90 days or 5 half-lives prior to first dosing of this
study);
11. History of abuse of addictive substances (alcohol, illegal substances) or
current use of more than 21 units of alcohol per week, drug abuse, or regular
user of sedatives, hypnotics, tranquillisers, or any other addictive agent;
12. Positive test for drugs of abuse at screening or pre-dose. Drugs test may
be repeated;
13. A routine smoker of tobacco products, currently or in the past year. No
(incidental) smoking will be allowed in the two weeks prior to first dosing;
14. Use of immunomodulatory drug; including systemic corticosteroids as well as
nasal preparations within 30 days before first dosing. Low dose topical use of
corticosteroids will be permitted. Other exceptions will only be made if the
rationale is clearly documented by the investigator;
15. Receipt of any vaccine within 1 week prior to IMP administration, or
planning to get vaccinated during the study;
16. Therapy with interferons, inte
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Frequency of local Treatment-Emergent Adverse Events (TEAEs)<br /><br>* Frequency of systemic Treatment-Emergent Adverse Events (TEAEs)<br /><br>* Frequency of any serious adverse events (SAEs)<br /><br>* Frequency of any withdrawals due to Adverse Events (AEs)<br /><br>* Frequency of any Dose Limiting Toxicities (DLTs)<br /><br>* Change in laboratory values, vital signs, physical examination findings<br /><br>(including nasal and oral examination)<br /><br>* Nasal pain assessed by visual analogue scale (VAS)<br /><br>* Integrity of the nasal mucosa by anterior rhinoscopy<br /><br>* Levels of mucosal cytokines<br /><br>* Characterization of mucosal immune cells </p><br>
- Secondary Outcome Measures
Name Time Method <p>N.A.</p><br>