Safety of Ascending Doses of Niclosamide (UNI911 INHALATION) in Healthy Volunteers

• Status: Completed
• Trial end date: 2020-12-04
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UNION therapeutics

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)