Covid19
Conditions
Brief summary
This is a Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults with COVID-19
Detailed description
This is a Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults with COVID-19 64 subjects will be sequentially enrolled to receive dosage of UNI911 INHALATION or placebo. 4 sentinel subjects (one per cohort 1, 2 ,3 and 4 ) will be treated in an open-label manner to confirm the safety of each dose sequentially. 40 subjects will be randomly assigned (3:1) to either active or placebo. For the last 2 cohorts, a total of 20 healthy volunteers will be enrolled to receive multiple doses of UNI911 INHALATION.
Interventions
DRUGUNI911 inhalation 1% and intranasal spray 1%
Niclosamide is a broad spectrum, host tageting antiviral that inhibits viral replication (by neutralizing endosomal pH) and increases viral clearance (by increasing the autophagic flux). The niclosamide 1% solution is administered as inhalation by nebulization and intranasal by a nasal spray.
DRUGPlacebo
The placebo formulation contains the vehicle. The solution is administered in the same way as the active drug. Placebo was only administered for cohorts 1-5.
Sponsors
UNION therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
(main ones): 1. Signed Informed Consent Form (ICF) 2. Male or non-pregnant and non-lactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study. Females must have a negative urine beta-human chorionic gonadotropin hormone (hCG) pregnancy test prior to dosing. (Women who are postmenopausal or who had tubal ligation/hysterectomy do not need to have a pregnancy test done and do not need to agree to use contraception.) 3. ECG without clinically significant abnormalities (including QTcF \< 450 ms) 4. Age ≥ 18 and \< 65 years at the time of signing ICF 5. Normally active and in good health by medical history and physical examination 6. Minimum 80% of predicted lung function, including FEV1 after beta2-agonist, TLC, DCO, and CPET with pulse oximetry 7. Chest X-ray without clinically significant abnormalities
Exclusion criteria
(main ones): 1. Enrollment in an UNI911 study in the previous 6 months 2. Clinically significant allergy (as judged by the investigator) or history of significant adverse reaction to niclosamide or related compounds, to any of the excipients used. 3. Underlying condition that may interfere with inhalation of the IP 4. Current acute or chronic condition (incl. COPD, asthma, or other severe respiratory disease, CV disease, diabetes mellitus, obesity, malignant and autoimmune diseases) unless considered clinically irrelevant and stable by the investigator 5. Renal impairment (eGFR \< 60 mL/min/1.73m2) or hepatic impairment (as judged by the investigator)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess safety of UNI911 INHALATION in healthy volunteers: AE frequency | Up to Day 6 | AE frequency in each cohort and treatment group |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Parameters: Cmax | Up to Day 4 of participant treatment | Maximum concentration of active drug molecules in blood (Cmax) |
| Pharmacokinetic Parameters: Tmax | Up to Day 4 of participant treatment | Time to reach maximum level (Tmax) |
| Pharmacokinetic Parameters: AUC | Up to Day 4 of participant treatment | Area Under the Curve of drug level in blood versus time (AUC) |
| Pharmacokinetic Parameters: Half life | Up to Day 4 of participant treatment | Half life |
Countries
Denmark
Outcome results
None listed