Clinical trial NCT04576312: Safety of Ascending Doses of Niclosamide (UNI911 INHALATION) in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Covid19
Lead sponsor: UNION therapeutics
Sponsor class: INDUSTRY
First posted: 2020-10-06
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Assess safety of UNI911 INHALATION in healthy volunteers: AE frequency
timeFrame: Up to Day 6
Secondary outcomes:
Other outcomes:
measure: Pharmacokinetic Parameters: Cmax
timeFrame: Up to Day 4 of participant treatment
measure: Pharmacokinetic Parameters: Tmax
timeFrame: Up to Day 4 of participant treatment
measure: Pharmacokinetic Parameters: AUC
timeFrame: Up to Day 4 of participant treatment
measure: Pharmacokinetic Parameters: Half life
timeFrame: Up to Day 4 of participant treatment
Locations:
city: Copenhagen
country: Denmark
facility: DanTrials ApS
Study officials:
affiliation: Dantrials Aps
name: Jesper Sonne, MD, DMSci
role: PRINCIPAL_INVESTIGATOR
References: