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
Overview
- Phase
- Phase 1
- Intervention
- UNI911 inhalation 1% and intranasal spray 1%
- Conditions
- Covid19
- Sponsor
- UNION therapeutics
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Assess safety of UNI911 INHALATION in healthy volunteers: AE frequency
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 1
Single dose of UNI911 inhalation (4 mL 0.1% \~ 3,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Intervention: UNI911 inhalation 1% and intranasal spray 1%
Cohort 1
Single dose of UNI911 inhalation (4 mL 0.1% \~ 3,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Intervention: Placebo
Cohort 2
Single dose of UNI911 inhalation (1 mL 1% \~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Intervention: UNI911 inhalation 1% and intranasal spray 1%
Cohort 2
Single dose of UNI911 inhalation (1 mL 1% \~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Intervention: Placebo
Cohort 3
Single dose of UNI911 inhalation (3 mL 1% \~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Intervention: UNI911 inhalation 1% and intranasal spray 1%
Cohort 3
Single dose of UNI911 inhalation (3 mL 1% \~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Intervention: Placebo
Cohort 4
Single dose of UNI911 inhalation (6 mL 1% \~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Intervention: UNI911 inhalation 1% and intranasal spray 1%
Cohort 4
Single dose of UNI911 inhalation (6 mL 1% \~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)
Intervention: Placebo
Cohort 5
UNI911 inhalation (6 mL 1% \~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg) BID for 2,5 days.
Intervention: UNI911 inhalation 1% and intranasal spray 1%
Cohort 5
UNI911 inhalation (6 mL 1% \~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg) BID for 2,5 days.
Intervention: Placebo
Cohort 6
UNI911 inhalation (1 mL 1% \~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg) BID for 6,5 days.
Intervention: UNI911 inhalation 1% and intranasal spray 1%
Cohort 7
UNI911 inhalation (3 mL 1% \~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg) BID for 6,5 days.
Intervention: UNI911 inhalation 1% and intranasal spray 1%
Placebo (applicable for cohorts 1-5)
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Assess safety of UNI911 INHALATION in healthy volunteers: AE frequency
Time Frame: Up to Day 6
AE frequency in each cohort and treatment group