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

UNION Therapeutics

Status and phase: Completed; Phase 1

Conditions: Covid19

Treatments: Drug: UNI911 inhalation 1% and intranasal spray 1%; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04576312

2020-002049-40 (EudraCT Number)

UNI911-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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64 participants in 8 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

Single dose of UNI911 inhalation (4 mL 0.1% \~ 3,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)

Treatment:

Drug: Placebo

Drug: UNI911 inhalation 1% and intranasal spray 1%

Cohort 2

Experimental group

Description:

Single dose of UNI911 inhalation (1 mL 1% \~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)

Treatment:

Drug: Placebo

Drug: UNI911 inhalation 1% and intranasal spray 1%

Cohort 3

Experimental group

Description:

Single dose of UNI911 inhalation (3 mL 1% \~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)

Treatment:

Drug: Placebo

Drug: UNI911 inhalation 1% and intranasal spray 1%

Cohort 4

Experimental group

Description:

Single dose of UNI911 inhalation (6 mL 1% \~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg)

Treatment:

Drug: Placebo

Drug: UNI911 inhalation 1% and intranasal spray 1%

Cohort 5

Experimental group

Description:

UNI911 inhalation (6 mL 1% \~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg) BID for 2,5 days.

Treatment:

Drug: Placebo

Drug: UNI911 inhalation 1% and intranasal spray 1%

Cohort 6

Experimental group

Description:

UNI911 inhalation (1 mL 1% \~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg) BID for 6,5 days.

Treatment:

Drug: UNI911 inhalation 1% and intranasal spray 1%

Cohort 7

Experimental group

Description:

UNI911 inhalation (3 mL 1% \~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% \~ 2,5 mg) BID for 6,5 days.

Treatment:

Drug: UNI911 inhalation 1% and intranasal spray 1%

Placebo (applicable for cohorts 1-5)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo