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

NCT04576312 | Completed Phase 1 DMC

• 2 other identifiers: UNI911-1012020-002049-40
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Assess safety of UNI911 INHALATION in healthy volunteers: AE frequency

  AE frequency in each cohort and treatment group

  Up to Day 6

Other Outcomes (4)

• Pharmacokinetic Parameters: Cmax

  Up to Day 4 of participant treatment

• Pharmacokinetic Parameters: Tmax

  Up to Day 4 of participant treatment

• Pharmacokinetic Parameters: AUC

  Up to Day 4 of participant treatment

Study Arms (8)

Cohort 1

EXPERIMENTAL

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

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

Cohort 2

EXPERIMENTAL

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

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

Cohort 3

EXPERIMENTAL

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

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

Cohort 4

EXPERIMENTAL

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

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

Cohort 5

EXPERIMENTAL

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

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

Cohort 6

EXPERIMENTAL

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

Drug: UNI911 inhalation 1% and intranasal spray 1%

Cohort 7

EXPERIMENTAL

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

Drug: UNI911 inhalation 1% and intranasal spray 1%

Placebo (applicable for cohorts 1-5)

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

UNI911 inhalation 1% and intranasal spray 1% DRUG

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.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

Placebo DRUG

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.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Placebo (applicable for cohorts 1-5)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form (ICF)
• 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.)
• ECG without clinically significant abnormalities (including QTcF \< 450 ms)
• Age ≥ 18 and \< 65 years at the time of signing ICF
• Normally active and in good health by medical history and physical examination
• Minimum 80% of predicted lung function, including FEV1 after beta2-agonist, TLC, DCO, and CPET with pulse oximetry
• Chest X-ray without clinically significant abnormalities

You may not qualify if:

• Enrollment in an UNI911 study in the previous 6 months
• 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.
• Underlying condition that may interfere with inhalation of the IP
• 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
• Renal impairment (eGFR \< 60 mL/min/1.73m2) or hepatic impairment (as judged by the investigator)

Sponsors & Collaborators

• UNION therapeutics: lead

Study Sites (1)

DanTrials ApS

Copenhagen, Denmark

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jesper Sonne, MD, DMSci

  Dantrials Aps

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 6, 2020
• Study Start: June 29, 2020
• Primary Completion: December 4, 2020
• Study Completion: December 4, 2020
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)