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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04576312
• Other study ID #: UNI911-101
• Secondary ID: 2020-002049-40
• Status: Completed
• Phase: Phase 1
• Start date: June 29, 2020
• Est. completion date: December 4, 2020

Study information

• Verified date: August 2021
• Source: UNION therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 4, 2020
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Covid19
• Respiratory Aspiration

Intervention

Drug:
• UNI911 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.
• Placebo
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.

Locations

Country	Name	City	State
Denmark	DanTrials ApS	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
UNION therapeutics

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetic Parameters: Cmax	Maximum concentration of active drug molecules in blood (Cmax)	Up to Day 4 of participant treatment
Other	Pharmacokinetic Parameters: Tmax	Time to reach maximum level (Tmax)	Up to Day 4 of participant treatment
Other	Pharmacokinetic Parameters: AUC	Area Under the Curve of drug level in blood versus time (AUC)	Up to Day 4 of participant treatment
Other	Pharmacokinetic Parameters: Half life	Half life	Up to Day 4 of participant treatment
Primary	Assess safety of UNI911 INHALATION in healthy volunteers: AE frequency	AE frequency in each cohort and treatment group	Up to Day 6