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

Phase 1

Completed

• Conditions: Covid19
• Interventions: Drug: UNI911 inhalation 1% and intranasal spray 1%; Drug: Placebo

• Registration Number: NCT04576312
• Lead Sponsor: UNION therapeutics

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.

Study Timeline

• Study Start: 2020-06-29
• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-06
• Primary Completion: 2020-12-04
• Study Completion: 2020-12-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 3	Placebo	Single dose of UNI911 inhalation (3 mL 1% \~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Cohort 5	Placebo	UNI911 inhalation (6 mL 1% \~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg) BID for 2,5 days.
Cohort 1	Placebo	Single dose of UNI911 inhalation (4 mL 0.1% \~ 3,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Cohort 1	UNI911 inhalation 1% and intranasal spray 1%	Single dose of UNI911 inhalation (4 mL 0.1% \~ 3,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Cohort 2	UNI911 inhalation 1% and intranasal spray 1%	Single dose of UNI911 inhalation (1 mL 1% \~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Cohort 5	UNI911 inhalation 1% and intranasal spray 1%	UNI911 inhalation (6 mL 1% \~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg) BID for 2,5 days.
Cohort 7	UNI911 inhalation 1% and intranasal spray 1%	UNI911 inhalation (3 mL 1% \~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg) BID for 6,5 days.
Cohort 4	UNI911 inhalation 1% and intranasal spray 1%	Single dose of UNI911 inhalation (6 mL 1% \~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Cohort 6	UNI911 inhalation 1% and intranasal spray 1%	UNI911 inhalation (1 mL 1% \~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg) BID for 6,5 days.
Placebo (applicable for cohorts 1-5)	Placebo	Placebo, administered in a double-blinded fashion (except for the first subjects of cohorts 1-4) at the same dose and frequency as UNI911 inhalation and intranasal spray.
Cohort 4	Placebo	Single dose of UNI911 inhalation (6 mL 1% \~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Cohort 2	Placebo	Single dose of UNI911 inhalation (1 mL 1% \~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Cohort 3	UNI911 inhalation 1% and intranasal spray 1%	Single dose of UNI911 inhalation (3 mL 1% \~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)

Primary Outcome Measures

Name	Time	Method
Assess safety of UNI911 INHALATION in healthy volunteers: AE frequency	Up to Day 6	AE frequency in each cohort and treatment group

Trial Locations

Locations (1)

DanTrials ApS; 🇩🇰 Copenhagen, Denmark