HealthyPhase 1NCT04705415

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

A Phase 1 study testing Niclosamide in people with Healthy, run by NeuroBo Pharmaceuticals Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Niclosamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 1 siteUnited States
Study dates: 17 Nov 2020to 28 Oct 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Sign the study informed consent form
Man or woman, 18 to 65 years of age inclusive at the time of signing the informed consent form
Overtly healthy as determined by medical evaluation
Body mass index (BMI) within 18 to 30.0 kg/m2 (inclusive) and body weight not less than 50 kg
Blood pressure at Screening and Day -1 between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.
A 12-lead electrocardiogram (ECG) at Screening consistent with normal cardiac conduction and function, including:

Show all 18Show fewer

Sinus rhythm
Pulse rate between 50 and 100 beats per minute (bpm)
QTc interval 450 milliseconds (QT interval corrected using Fridericia correction method [QTcF])
QRS interval of <120 milliseconds
PR interval <200 milliseconds
Morphology consistent with healthy cardiac conduction and function
Non-smoker or ex-smoker for >12 months
If male, must agree to use contraception methods outlined for the study during the treatment period and for at least 30 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period
If female, is not pregnant, not breastfeeding, and meets at least one of the following conditions:
Not a woman of childbearing potential (WOCBP)
OR
A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days (one menstrual cycle) after the last dose of study treatment.

Who cannot join

Has a history of or current clinically significant medical illness including but not limited to, cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); lipid abnormalities; significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; hepatic or renal insufficiency (creatinine clearance below 60 mL/min); thyroid disease; neurologic or psychiatric disease; infection; or any other illness that the Investigator considers should exclude the subject or that could interfere with the interpretation of the study results.
Has known allergy to niclosamide or salicylate-containing medications.
Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening.
Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening.
Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse at screening and admission

Show all 9Show fewer

Has received an investigational drug or used an invasive investigational medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before Day 1.
Has preplanned surgery or procedures that would interfere with the conduct of the study
Is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, as well as family members of the employees or the Investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

WCCT Global Inc.
Cypress, California, 90630

Other trials in United States

About this study

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

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

Read the 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
Being tested: Niclosamide, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NiclosamideDrug
Also called ANA001
Niclosamide is an antihelmintic with in-vitro antiviral activity
PlaceboDrug
Also called Matching Placebo to ANA001
Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients

Study groups in NCT04705415
Study group	Role	What they receive
SAD Cohort 1: ANA001 1000 mg po	Experimental	Subjects will receive a 1000 mg single oral dose of ANA001 with a standardized light meal presented at 4 x 250 mg capsules. Each capsule is 250 mg. Receives: Drug: Niclosamide
SAD Cohort 2: ANA001 2000 mg po	Experimental	Subjects will a 2000 mg single oral dose of ANA001 with a standardized light meal presented at 8 x 250 mg capsules. Each capsule is 250 mg. Receives: Drug: Niclosamide
SAD Cohort 3: ANA001 3000 mg po	Experimental	Subjects will a 3000 mg single oral dose of ANA001 with a standardized light meal presented at 12 x 250 mg capsules. Each capsule is 250 mg. Receives: Drug: Niclosamide
SAD Cohorts 1, 2 & 3: Pooled Matching Placebo	Placebo comparator	Subjects will receive matching placebo hydroxypropylmethylcellulose (HPMC) as a single oral dose (4, 8, or 12 capsules) with a standardized light meal. Receives: Drug: Placebo
MAD Cohort 1: ANA001 1000 mg po BID	Experimental	Subjects will receive an oral dose of 1000mg ANA001 twice daily (BID) with a standardized light meal for 7 consecutive days. Each dose will be presented as 4 250mg capsules. Receives: Drug: Niclosamide
MAD Cohort 2: ANA001 1000 mg po TID	Experimental	Subjects will receive an oral dose of 1000mg ANA001 three times daily (TID) with a standardized light meal for 7 consecutive days. Each dose will be presented as 4 250mg capsules. Receives: Drug: Niclosamide
MAD Cohorts 1 & 2: Pooled Matching Placebo	Placebo comparator	Subjects will receive an oral dose of matching Placebo to ANA001 two (BID) three times daily (TID) with a standardized light meal for 7 consecutive days. Each dose will be presented as 4 250mg capsules of hydroxypropylmethylcellulose (HPMC) Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

SAD: Number of Subjects Reporting TEAEs and STEAEs
Number of Subjects Reporting treatment-emergent AEs (TEAEs) and Serious treatment-emergent AEs (STEAEs) in the SAD
Measured: Baseline to Day 7.
MAD: Number of Subjects Reporting TEAEs and STEAEs
Number of Subjects Reporting treatment-emergent AEs (TEAEs) and Serious treatment-emergent AEs (STEAEs) in the MAD
Measured: Baseline to Day 14.
SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in ECG Parameters
Number of Subjects with Clinically Significant changes in ECG parameters from Baseline (PR, QRS, QT, and QTc intervals)
Measured: Baseline to Day 7
MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in ECG Parameters
Number of Subjects with Clinically Significant changes in ECG parameters from Baseline (PR, QRS, QT, and QTc intervals)
Measured: Baseline to Day 14
SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Haematology
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 (%))
Measured: Baseline to Day 7
MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Haematology
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 (%))
Measured: Baseline to Day 14
SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Serum Chemistry
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)
Measured: Baseline to Day 7
MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Serum Chemistry
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)
Measured: Baseline to Day 14
SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Urinalysis
Number of Subjects with Clinically Significant changes in Urinalysis (Specific Gravity, Urobilinogen (EU), pH)
Measured: Baseline to Day 7
MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Urinalysis
Number of Subjects with Clinically Significant changes in Urinalysis (Specific Gravity, Urobilinogen (EU), pH)
Measured: Baseline to Day 14
SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Vital Signs
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))
Measured: Baseline to Day 7
MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Vital Signs
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))
Measured: Baseline to Day 14

Secondary outcomes (21)

SAD: Tmax
Time to reach the maximum plasma concentration (SAD)
Measured: PK samples were collected before dosing and at 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours. A Follow-up sample was taken Day 7 (±2) after dosing.
SAD: Cmax
Maximum plasma concentration during a dosing interval (SAD)
Measured: PK samples were collected before dosing and at 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours. A Follow-up sample was taken Day 7 (±2) after dosing.
SAD: AUC0-t
Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration (SAD)
Measured: PK samples were collected before dosing and at 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours. A Follow-up sample was taken Day 7 (±2) after dosing.
SAD: AUC0-∞
Area under the plasma concentration time curve from time 0 extrapolated to infinity, calculated as AUC0-last + Clast/λ, where Clast is the last quantifiable concentration at time t (SAD)
Measured: PK samples were collected before dosing and at 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours. A Follow-up sample was taken Day 7 (±2) after dosing.
SAD: t1/2
Elimination half-life associated with the terminal slope (λ) of the semilogarithmic drug concentration-time curve, calculated as 0.693/λ (SAD)
Measured: PK samples were collected before dosing and at 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours. A Follow-up sample was taken Day 7 (±2) after dosing.
SAD: CL/F
Systemic Clearance (SAD)
Measured: PK samples were collected before dosing and at 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours. A Follow-up sample was taken Day 7 (±2) after dosing.
SAD: Vz/F
Volume of distribution (SAD)
Measured: PK samples were collected before dosing and at 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours. A Follow-up sample was taken Day 7 (±2) after dosing.
MAD: Tmax Day 1
Time to reach the maximum plasma concentration Day 1
Measured: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: Tmax Day 7
Time to reach the maximum plasma concentration (Day 7)
Measured: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: Cmax Day 1
Maximum plasma concentration during a dosing interval (Day 1)
Measured: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: For BID but omitting samples at 10, and 12 hours after dosing.
MAD: Cmax Day 7
Maximum plasma concentration during a dosing interval (Day 7)
Measured: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: AUC0-t Day 1
Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration (Day 1)
Measured: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: AUC0-t Day 7
Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration (Day 7)
Measured: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: AUC0-tau Day 1
Area under the plasma concentration-time curve over the dosing interval at steady-state, calculated from the dosing interval (Day 1)
Measured: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: AUC0-tau Day 7
Area under the plasma concentration-time curve over the dosing interval at steady-state, calculated from the dosing interval (Day 7)
Measured: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: t1/2 Day 1
Elimination half-life associated with the terminal slope (λ) of the semilogarithmic drug concentration-time curve, calculated as 0.693/λ (Day 1)
Measured: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: t1/2 Day 7
Elimination half-life associated with the terminal slope (λ) of the semilogarithmic drug concentration-time curve, calculated as 0.693/λ (Day 7)
Measured: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: CLss Day 1
Systemic Clearance at steady state (Day 1)
Measured: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: CLss Day 7
Systemic Clearance at steady state (Day 7)
Measured: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: Vdss Day 1
Volume of distribution at steady state (Day 1)
Measured: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: Vdss Day 7
Volume of distribution at steady state (Day 7)
Measured: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 202028 Oct 2022

First posted12 Jan 2021
Study start17 Nov 2020
Primary completion13 Oct 2021
Study completion28 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04705415
Sponsor's protocol ID: ANA001-002
Status last verified: Jan 2025
First submitted: 8 Dec 2020
Last updated: 3 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Single and Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Niclosamide in Healthy Adults
ClinicalTrials.gov ID: NCT04705415
Acronym / sponsor ID: ANA001-002
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: NeuroBo Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: 17 Nov 2020 (actual)
Primary completion: 13 Oct 2021 (actual)
Study completion: 28 Oct 2022 (actual)
First posted: 12 Jan 2021 (actual)
Results: Posted 3 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 7

Arm	Type	Receives
SAD Cohort 1: ANA001 1000 mg po	Experimental	Drug: NiclosamideSubjects will receive a 1000 mg single oral dose of ANA001 with a standardized light meal presented at 4 x 250 mg capsules. Each capsule is 250 mg.
SAD Cohort 2: ANA001 2000 mg po	Experimental	Drug: NiclosamideSubjects will a 2000 mg single oral dose of ANA001 with a standardized light meal presented at 8 x 250 mg capsules. Each capsule is 250 mg.
SAD Cohort 3: ANA001 3000 mg po	Experimental	Drug: NiclosamideSubjects will a 3000 mg single oral dose of ANA001 with a standardized light meal presented at 12 x 250 mg capsules. Each capsule is 250 mg.
SAD Cohorts 1, 2 & 3: Pooled Matching Placebo	Placebo comparator	Drug: PlaceboSubjects will receive matching placebo hydroxypropylmethylcellulose (HPMC) as a single oral dose (4, 8, or 12 capsules) with a standardized light meal.
MAD Cohort 1: ANA001 1000 mg po BID	Experimental	Drug: NiclosamideSubjects will receive an oral dose of 1000mg ANA001 twice daily (BID) with a standardized light meal for 7 consecutive days. Each dose will be presented as 4 250mg capsules.
MAD Cohort 2: ANA001 1000 mg po TID	Experimental	Drug: NiclosamideSubjects will receive an oral dose of 1000mg ANA001 three times daily (TID) with a standardized light meal for 7 consecutive days. Each dose will be presented as 4 250mg capsules.
MAD Cohorts 1 & 2: Pooled Matching Placebo	Placebo comparator	Drug: PlaceboSubjects will receive an oral dose of matching Placebo to ANA001 two (BID) three times daily (TID) with a standardized light meal for 7 consecutive days. Each dose will be presented as 4 250mg capsules of hydroxypropylmethylcellulose (HPMC)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Sign the study informed consent form
Man or woman, 18 to 65 years of age inclusive at the time of signing the informed consent form
Overtly healthy as determined by medical evaluation
Body mass index (BMI) within 18 to 30.0 kg/m2 (inclusive) and body weight not less than 50 kg
Blood pressure at Screening and Day -1 between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.

Key exclusion criteria (9 listed)

Has a history of or current clinically significant medical illness including but not limited to, cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); lipid abnormalities; significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; hepatic or renal insufficiency (creatinine clearance below 60 mL/min); thyroid disease; neurologic or psychiatric disease; infection; or any other illness that the Investigator considers should exclude the subject or that could interfere with the interpretation of the study results.
Has known allergy to niclosamide or salicylate-containing medications.
Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening.
Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening.
Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NiclosamideAlso: ANA001Niclosamide is an antihelmintic with in-vitro antiviral activity	Drug	MAD Cohort 1: ANA001 1000 mg po BID, MAD Cohort 2: ANA001 1000 mg po TID, SAD Cohort 1: ANA001 1000 mg po, SAD Cohort 2: ANA001 2000 mg po, SAD Cohort 3: ANA001 3000 mg po
PlaceboAlso: Matching Placebo to ANA001Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients	Drug	MAD Cohorts 1 & 2: Pooled Matching Placebo, SAD Cohorts 1, 2 & 3: Pooled Matching Placebo

Primary outcome

SAD: Number of Subjects Reporting TEAEs and STEAEs
Time frame: Baseline to Day 7.
Number of Subjects Reporting treatment-emergent AEs (TEAEs) and Serious treatment-emergent AEs (STEAEs) in the SAD
MAD: Number of Subjects Reporting TEAEs and STEAEs
Time frame: Baseline to Day 14.
Number of Subjects Reporting treatment-emergent AEs (TEAEs) and Serious treatment-emergent AEs (STEAEs) in the MAD
SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in ECG Parameters
Time frame: Baseline to Day 7
Number of Subjects with Clinically Significant changes in ECG parameters from Baseline (PR, QRS, QT, and QTc intervals)
MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in ECG Parameters
Time frame: Baseline to Day 14
Number of Subjects with Clinically Significant changes in ECG parameters from Baseline (PR, QRS, QT, and QTc intervals)
SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Haematology
Time frame: 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 (%))
MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Haematology
Time frame: Baseline to Day 14
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 (%))
SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Serum Chemistry
Time frame: 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)
MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Serum Chemistry
Time frame: Baseline to Day 14
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)
SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Urinalysis
Time frame: Baseline to Day 7
Number of Subjects with Clinically Significant changes in Urinalysis (Specific Gravity, Urobilinogen (EU), pH)
MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Urinalysis
Time frame: Baseline to Day 14
Number of Subjects with Clinically Significant changes in Urinalysis (Specific Gravity, Urobilinogen (EU), pH)
SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Vital Signs
Time frame: 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))
MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in Vital Signs
Time frame: 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))

21 secondary outcomes

SAD: Tmax
Time frame: PK samples were collected before dosing and at 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours. A Follow-up sample was taken Day 7 (±2) after dosing.
SAD: Cmax
Time frame: PK samples were collected before dosing and at 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours. A Follow-up sample was taken Day 7 (±2) after dosing.
SAD: AUC0-t
Time frame: PK samples were collected before dosing and at 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours. A Follow-up sample was taken Day 7 (±2) after dosing.
SAD: AUC0-∞
Time frame: PK samples were collected before dosing and at 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours. A Follow-up sample was taken Day 7 (±2) after dosing.
SAD: t1/2
Time frame: PK samples were collected before dosing and at 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours. A Follow-up sample was taken Day 7 (±2) after dosing.
SAD: CL/F
Time frame: PK samples were collected before dosing and at 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours. A Follow-up sample was taken Day 7 (±2) after dosing.
SAD: Vz/F
Time frame: PK samples were collected before dosing and at 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours. A Follow-up sample was taken Day 7 (±2) after dosing.
MAD: Tmax Day 1
Time frame: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: Tmax Day 7
Time frame: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: Cmax Day 1
Time frame: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: For BID but omitting samples at 10, and 12 hours after dosing.
MAD: Cmax Day 7
Time frame: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: AUC0-t Day 1
Time frame: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: AUC0-t Day 7
Time frame: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: AUC0-tau Day 1
Time frame: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: AUC0-tau Day 7
Time frame: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: t1/2 Day 1
Time frame: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: t1/2 Day 7
Time frame: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: CLss Day 1
Time frame: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: CLss Day 7
Time frame: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: Vdss Day 1
Time frame: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.
MAD: Vdss Day 7
Time frame: BID: Samples on Days 1 and 7 before dosing and at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours after dosing; Days 2, 4, 6, and 8 before dosing and before the 12 h. dose on Days 2, 4, and 6.TID: As BID but omitting samples at 10, and 12 hours after dosing.

Results and safety

Results posted to the registry on 3 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SAD Cohort 1: ANA001 1000 mg po	8	7
SAD Cohort 2: ANA001 2000 mg po	8	7
SAD Cohort 3: ANA001 3000 mg po	8	8
SAD Cohorts 1, 2 & 3: Pooled Matching Placebo	6	5
MAD Cohort 1: ANA001 1000 mg po BID	9	8
MAD Cohort 2: ANA001 1000 mg po TID	9	9
MAD Cohorts 1 & 2: Pooled Matching Placebo	6	5

Primary outcome: SAD: Number of Subjects Reporting TEAEs and STEAEs

Time frame: Baseline to Day 7.. Number. Unit: participants

Measure	SAD Cohort 1: ANA001 1000 mg po n = 8	SAD Cohort 2: ANA001 2000 mg po n = 8	SAD Cohort 3: ANA001 3000 mg po n = 8	SAD Cohorts 1, 2 & 3: Pooled Matching Placebo n = 6
Number of Subjects Reporting treatment-emergent AEs (TEAEs)	0	0	0	1
Number of Subjects Reporting treatment-emergent Serious AEs (STEAEs)	0	0	0	0

Primary outcome: MAD: Number of Subjects Reporting TEAEs and STEAEs

Time frame: Baseline to Day 14.. Number. Unit: participants

Measure	MAD Cohort 1: ANA001 1000 mg po BID n = 9	MAD Cohort 2: ANA001 1000 mg po TID n = 9	MAD Cohorts 1 & 2: Pooled Matching Placebo n = 6
Number of Subjects Reporting TEAEs	3	3	1
Number of Subjects Reporting STEAEs	0	0	0

Primary outcome: SAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in ECG Parameters

Time frame: Baseline to Day 7. Number. Unit: participants

Measure	SAD Cohort 1: ANA001 1000 mg po n = 8	SAD Cohort 2: ANA001 2000 mg po n = 8	SAD Cohort 3: ANA001 3000 mg po n = 8	SAD Cohorts 1, 2 & 3: Pooled Matching Placebo n = 6
Value	0	0	0	0

Primary outcome: MAD: Safety and Tolerability of ANA001 as Measured by Clinically Significant Changes in ECG Parameters

Time frame: Baseline to Day 14. Number. Unit: participants

Measure	MAD Cohort 1: ANA001 1000 mg po BID n = 9	MAD Cohort 2: ANA001 1000 mg po TID n = 9	MAD Cohorts 1 & 2: Pooled Matching Placebo n = 6
Value	0	0	0

21 secondary outcomes are reported in the full results.

Adverse events

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).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SAD Cohort 1: ANA001 1000 mg po	0 of 8 (0%)	0 of 8 (0%)	0 of 8
SAD Cohort 2: ANA001 2000 mg po	0 of 8 (0%)	0 of 8 (0%)	0 of 8
SAD Cohort 3: ANA001 3000 mg po	0 of 8 (0%)	0 of 8 (0%)	0 of 8
SAD Cohorts 1, 2 & 3: Pooled Matching Placebo	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
MAD Cohort 1: ANA001 1000 mg po BID	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
MAD Cohort 2: ANA001 1000 mg po TID	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
MAD Cohorts 1 & 2: Pooled Matching Placebo	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Doug Rank, MD study director

NeuroBo Pharmaceuticals Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Niclosamide in people with Healthy, run by NeuroBo Pharmaceuticals Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SAD: Number of Subjects Reporting TEAEs and STEAEs (time frame: Baseline to Day 7.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04705415.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.