NCT04705415

A Single and Multiple Ascending Dose Study of Niclosamide in Healthy Volunteers

A Randomized, Double-Blind, Single and Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Niclosamide in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: NeuroBo Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A single and multiple ascending dose study of ANA001 in healthy adults to assess the safety and pharmacokinetics

Detailed description

This is a Phase 1, single center, randomized, double blind, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety and pharmacokinetics of ANA001 in healthy adult subjects. In the single ascending dose portion of the study, subjects in 3 cohorts of 10 subjects each will be randomized to receive a single daily oral dose of ANA001 or matching placebo. In the multiple ascending dose portion of the study, subjects in 3 cohorts of 12 subjects each will be randomized to receive twice or thrice daily oral dose of ANA001 or matching placebo.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Niclosamide	Niclosamide is an antihelmintic with in-vitro antiviral activity
DRUG	Placebo	Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients

Timeline

• Start date: 2020-11-17
• Primary completion: 2021-10-13
• Completion: 2022-10-28
• First posted: 2021-01-12
• Last updated: 2025-02-03
• Results posted: 2025-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study