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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04705415
• Other study ID #: ANA001-002
• Status: Completed
• Phase: Phase 1
• Start date: November 17, 2020
• Est. completion date: October 28, 2022

Study information

• Verified date: December 2023
• Source: NeuroBo Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 28, 2022
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Sign the study informed consent form

2. Man or woman, 18 to 65 years of age inclusive at the time of signing the informed consent form

3. Overtly healthy as determined by medical evaluation

4. Body mass index (BMI) within 18 to 30.0 kg/m2 (inclusive) and body weight not less than 50 kg

5. Blood pressure at Screening and Day -1 between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.

6. A 12-lead electrocardiogram (ECG) at Screening consistent with normal cardiac conduction and function, including:

• 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

7. Non-smoker or ex-smoker for >12 months

8. 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

9. 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.

Exclusion Criteria:

1. 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.

2. Has known allergy to niclosamide or salicylate-containing medications.

3. Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening.

4. Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening.

5. 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.

6. 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

7. 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.

8. Has preplanned surgery or procedures that would interfere with the conduct of the study

9. 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Niclosamide
Niclosamide is an antihelmintic with in-vitro antiviral activity
• Placebo
Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients

Locations

Country	Name	City	State
United States	WCCT Global Inc.	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
NeuroBo Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of ANA001 as measured by the incidence of treatment-emergent AEs (TEAEs) and serious adverse events (SAEs)	Incidence of treatment-emergent AEs (TEAEs) and serious adverse events (SAEs)	Baseline to Day 7 for SAD portion; Baseline to Day 15 for MAD portion
Primary	Safety and tolerability of ANA001 as measured by the incidence of study drug discontinuations due to an adverse event (AE) (MAD portion only)	Incidence of study drug discontinuations due to an Adverse Event (AE)	Baseline to Day 15
Primary	Safety and tolerability of ANA001 as measured by the use of concomitant medications	Incidence in the use of concomitant medications	Baseline to Day 7 for SAD portion; Baseline to Day 15 for MAD portion
Primary	Safety and tolerability of ANA001 as measured by the change from baseline in clinical laboratory test results	Incidence of change in clinical laboratory test results (hematology, serum chemistry, urinalysis)	Baseline to Day 7 for SAD portion; Baseline to Day 15 for MAD portion
Primary	Safety and tolerability of ANA001 as measured by the change from baseline in vital signs	Incidence of change from baseline in vital signs (oral temperature, pulse rate, respiratory rate, and blood pressure)	Baseline to Day 7 for SAD portion; Baseline to Day 15 for MAD portion
Primary	Safety and tolerability of ANA001 as measured by the change in ECG parameters	Incidence of change from baseline in ECG parameters (PR, QRS, QT, and QTc intervals)	Baseline to Day 1 for SAD portion; Baseline to Day 7 for MAD portion
Primary	Safety and tolerability of ANA001 as measured by the change incidence of physical example findings	Incidence of physical exam findings	Baseline to Day 1 for SAD portion; Baseline to Day 7 for MAD portion
Secondary	Pharmacokinetics (PK) of ANA001 as measured by plasma concentrations	Plasma concentrations of ANA001	single ascending dose (Day 1); multiple ascending dose (Day 1 to 8)