NCT04705415 is a Phase 1 clinical trial of Niclosamide in Healthy, sponsored by NeuroBo Pharmaceuticals Inc..

Who is sponsoring NCT04705415?

NCT04705415 is sponsored by NeuroBo Pharmaceuticals Inc..

What drugs are being tested in NCT04705415?

Interventions in NCT04705415: Niclosamide, Placebo.

Is NCT04705415 still recruiting?

NCT04705415 is currently completed. Last updated 3 February 2025.

Are results published for NCT04705415?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-02-03 · How we verify

NCT04705415

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 3 February 2025

What this trial tests

Phase 1 trial testing Niclosamide in Healthy in 54 participants. Completed in 28 October 2022.

Timeline

17 November 2020

Primary endpoint
13 October 2021

28 October 2022

Quick facts

Lead sponsor	NeuroBo Pharmaceuticals Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	54
Start date	17 November 2020
Primary completion	13 October 2021
Estimated completion	28 October 2022
Sites	1 location across United States

Drugs / interventions tested

Niclosamide — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

NeuroBo Pharmaceuticals Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

SAD: Number of Subjects Reporting TEAEs and STEAEs Primary · Baseline to Day 7.

Number of Subjects Reporting treatment-emergent AEs (TEAEs) and Serious treatment-emergent AEs (STEAEs) in the SAD

Number of Subjects Reporting treatment-emergent AEs (TEAEs)

Group	Value	95% CI
SAD Cohort 1: ANA001 1000 mg po	0
SAD Cohort 2: ANA001 2000 mg po	0
SAD Cohort 3: ANA001 3000 mg po	0
SAD Cohorts 1, 2 & 3: Pooled Matching Placebo	1

Number of Subjects Reporting treatment-emergent Serious AEs (STEAEs)

Group	Value	95% CI
SAD Cohort 1: ANA001 1000 mg po	0
SAD Cohort 2: ANA001 2000 mg po	0
SAD Cohort 3: ANA001 3000 mg po	0
SAD Cohorts 1, 2 & 3: Pooled Matching Placebo	0

MAD: Number of Subjects Reporting TEAEs and STEAEs Primary · Baseline to Day 14.

Number of Subjects Reporting treatment-emergent AEs (TEAEs) and Serious treatment-emergent AEs (STEAEs) in the MAD

Number of Subjects Reporting TEAEs

Group	Value	95% CI
MAD Cohort 1: ANA001 1000 mg po BID	3
MAD Cohort 2: ANA001 1000 mg po TID	3
MAD Cohorts 1 & 2: Pooled Matching Placebo	1

Number of Subjects Reporting STEAEs

Group	Value	95% CI
MAD Cohort 1: ANA001 1000 mg po BID	0
MAD Cohort 2: ANA001 1000 mg po TID	0
MAD Cohorts 1 & 2: Pooled Matching Placebo	0

SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in ECG Parameters Primary · Baseline to Day 7

Number of Subjects with Clinically Significant changes in ECG parameters from Baseline (PR, QRS, QT, and QTc intervals)

Group	Value	95% CI
SAD Cohort 1: ANA001 1000 mg po	0
SAD Cohort 2: ANA001 2000 mg po	0
SAD Cohort 3: ANA001 3000 mg po	0
SAD Cohorts 1, 2 & 3: Pooled Matching Placebo	0

MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in ECG Parameters Primary · Baseline to Day 14

Number of Subjects with Clinically Significant changes in ECG parameters from Baseline (PR, QRS, QT, and QTc intervals)

Group	Value	95% CI
MAD Cohort 1: ANA001 1000 mg po BID	0
MAD Cohort 2: ANA001 1000 mg po TID	0
MAD Cohorts 1 & 2: Pooled Matching Placebo	0

SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Haematology Primary · Baseline to Day 7

Number of Subjects with Clinically Significant changes in Haematology (Basophils (%),Eosinophils (%, Ery. Mean Corpuscular Hemoglobin, Ery. Mean Corpuscular Volume, Erythrocytes (10\^12/L), Hematocrit (%), Hemoglobin (g/dL). Hemoglobin (g/dL), Lymphocytes (%), Monocytes (%), Neutrophils (%)' Platelets (10\^9/L), Reticulocytes (%))

Group	Value	95% CI
SAD Cohort 1: ANA001 1000 mg po	0
SAD Cohort 2: ANA001 2000 mg po	0
SAD Cohort 3: ANA001 3000 mg po	0
SAD Cohorts 1, 2 & 3: Pooled Matching Placebo	0

MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Haematology Primary · Baseline to Day 14

Group	Value	95% CI
MAD Cohort 1: ANA001 1000 mg po BID	0
MAD Cohort 2: ANA001 1000 mg po TID	0
MAD Cohorts 1 & 2: Pooled Matching Placebo	0

SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Serum Chemistry Primary · Baseline to Day 7

Number of Subjects with Clinically Significant changes in Serum Chemistry (Alanine Aminotransferase (U/L), Alkaline Phosphatase (U/L), Aspartate Aminotransferase (U/L), Bilirubin (mg/dL), Calcium (mg/dL), Creatinine (mg/dL), Direct Bilirubin (mg/dL, Glucose (mg/dL), Potassium (mmol/L), Protein (g/dL), Sodium (mmol/L), Urea Nitrogen (mg/dL)

Group	Value	95% CI
SAD Cohort 1: ANA001 1000 mg po	0
SAD Cohort 2: ANA001 2000 mg po	0
SAD Cohort 3: ANA001 3000 mg po	0
SAD Cohorts 1, 2 & 3: Pooled Matching Placebo	0

MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Serum Chemistry Primary · Baseline to Day 14

Group	Value	95% CI
MAD Cohort 1: ANA001 1000 mg po BID	0
MAD Cohort 2: ANA001 1000 mg po TID	0
MAD Cohorts 1 & 2: Pooled Matching Placebo	0

SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Urinalysis Primary · Baseline to Day 7

Number of Subjects with Clinically Significant changes in Urinalysis (Specific Gravity, Urobilinogen (EU), pH)

Group	Value	95% CI
SAD Cohort 1: ANA001 1000 mg po	0
SAD Cohort 2: ANA001 2000 mg po	0
SAD Cohort 3: ANA001 3000 mg po	0
SAD Cohorts 1, 2 & 3: Pooled Matching Placebo	0

MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Urinalysis Primary · Baseline to Day 14

Number of Subjects with Clinically Significant changes in Urinalysis (Specific Gravity, Urobilinogen (EU), pH)

Group	Value	95% CI
MAD Cohort 1: ANA001 1000 mg po BID	0
MAD Cohort 2: ANA001 1000 mg po TID	0
MAD Cohorts 1 & 2: Pooled Matching Placebo	0

SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Vital Signs Primary · Baseline to Day 7

Number of Subjects with Clinically Significant changes in Vital Signs from Baseline (Diastolic Blood Pressure, Systolic Blood Pressure (mmHg), Pulse Rate (beats/min), Respiratory Rate (breaths/min))

Group	Value	95% CI
SAD Cohort 1: ANA001 1000 mg po	0
SAD Cohort 2: ANA001 2000 mg po	0
SAD Cohort 3: ANA001 3000 mg po	0
SAD Cohorts 1, 2 & 3: Pooled Matching Placebo	0

MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Vital Signs Primary · Baseline to Day 14

Number of Subjects with Clinically Significant changes in Vital Signs from Baseline (Diastolic Blood Pressure, Systolic Blood Pressure (mmHg), Pulse Rate (beats/min), Respiratory Rate (breaths/min))

Group	Value	95% CI
MAD Cohort 1: ANA001 1000 mg po BID	0
MAD Cohort 2: ANA001 1000 mg po TID	0
MAD Cohorts 1 & 2: Pooled Matching Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: SAD: Adverse Event Collected from Dosing to 7 days after dosing (8 days). MAD: Adverse Event Collected from Dosing on Day 1 to 7 days after final dosing day (15 days).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SAD Cohort 1: ANA001 1000 mg po

Serious: 0/8 (0%)

Deaths: 0/8

SAD Cohort 2: ANA001 2000 mg po

Serious: 0/8 (0%)

Deaths: 0/8

SAD Cohort 3: ANA001 3000 mg po

Serious: 0/8 (0%)

Deaths: 0/8

SAD Cohorts 1, 2 & 3: Pooled Matching Placebo

Serious: 0/6 (0%)

Deaths: 0/6

MAD Cohort 1: ANA001 1000 mg po BID

Serious: 0/9 (0%)

Deaths: 0/9

MAD Cohort 2: ANA001 1000 mg po TID

Serious: 0/9 (0%)

Deaths: 0/9

MAD Cohorts 1 & 2: Pooled Matching Placebo

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (8 terms — click to expand)

Reaction	System	SAD Cohort 1: ANA001 1000 …	SAD Cohort 2: ANA001 2000 …	SAD Cohort 3: ANA001 3000 …	SAD Cohorts 1, 2 & 3: Pool…	MAD Cohort 1: ANA001 1000 …	MAD Cohort 2: ANA001 1000 …	MAD Cohorts 1 & 2: Pooled …
Dizziness	Nervous system disorders	—	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Headaches NEC	Nervous system disorders	—	—	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—	—	—
Haemorrhoids	Gastrointestinal disorders	—	—	—	—	—	—	—
Skin Laceration	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Acne	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT04705415 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Niclosamide

Trials testing the same drug.

NCT04932915 — Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19 · Phase 2 · terminated
NCT04858425 — Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection · Phase 2 · terminated
NCT04870333 — PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V · Phase 2, PHASE3 · completed
NCT04644705 — Safety and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat · Phase 1 · completed
NCT04603924 — Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients · Phase 2, PHASE3 · completed

Other recruiting trials for Healthy

Currently open trials in the same condition.

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NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other NeuroBo Pharmaceuticals Inc. trials

Trials by the same sponsor.

NCT06252220 — First in Human Study in Subjects With Obesity, But Otherwise Healthy · Phase 1 · recruiting
NCT06054815 — Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH · Phase 2 · completed
NCT04603924 — Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients · Phase 2, PHASE3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04705415 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NeuroBo Pharmaceuticals Inc.
Last refreshed: 3 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04705415.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04705415

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Niclosamide

Other recruiting trials for Healthy

Other NeuroBo Pharmaceuticals Inc. trials

Verify against primary sources