HealthyPhase 1NCT05168644
Single Ascending Dose and Multiple Ascending Dose Study of Niclosamide Inhalation Powder in Healthy Adult Subjects
A Phase 1 study testing Niclosamide Inhalation Powder in people with Healthy, run by TFF Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of Niclosamide Inhalation Powder versus placebo (SAD part) and escalating multiple doses of Niclosamide Inhalation Powder versus… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Niclosamide Inhalation Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 14 Nov 2021to 26 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agree to use acceptable contraception or is not able to bear children.
- Body mass index (BMI) within ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2 at Screening (body weight of at least 50.0 kg and no more than120 kg at Screening).
- Non-smoker or ex-smoker (stopped using nicotine products for at least 12 months prior to the first study drug administration and throughout the study).
- Have no clinically significant diseases, including asthma, captured in the medical history or on the physical examination, visual examination, clinical laboratory assessments, and/or ECG.
- A forced expiratory volume during the first second (FEV1) ≥ 80% at Screening and Check-in.
Who cannot join
- Female who is lactating, is pregnant or planning to become pregnant according to the pregnancy test at Screening or prior to the first study drug administration.
- Is mentally or legally incapacitated or unable to provide informed consent.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first study drug administration.
- History or presence of hypersensitivity or idiosyncratic reaction to niclosamide or any portion of the placebo.
- Has had surgery or any medical condition within 6 months prior to first study drug administration which may affect the absorption, distribution, metabolism, or elimination of the study drug, in the opinion of the PI or designee.
- Use of albuterol or a similar bronchodilator.
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- Immunization with a COVID-19 vaccine in the 14 days prior to the first study drug administration.
- Scheduled immunization with a COVID-19 vaccine (first or second dose) during the study that, in the opinion of an investigator, could potentially interfere with subject participation, subject safety, study results, or any other reason.
- History or allergy of rare hereditary problems of galactose and/or lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing and throughout the study.
- Seasonal use of albuterol or other similar inhalers throughout study participation, beginning 14 days prior to the first dosing or 5 half-lives, whichever is longer.
- Use of St. John's wort in the 28 days prior to the first study drug administration.
- Positive Screening results for tuberculosis, HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus tests, or a positive test for alcohol, cotinine, and/or drugs of abuse.
- Participation in another clinical study within 30 days prior to the first study drug administration. The 30-day window will be derived from the date of the last study drug administration.
- Had a treatment with another investigational drug within 5 times the elimination half-life, if known (eg, a marketed product) or within 30 days (if the elimination half-life is unknown) prior to the first study drug administration.
- Donation of plasma in the 14 days prior to the first study drug administration.
- Donation or loss of 500 mL or more of blood in the 56 days prior to the first study drug administration.
- Demonstrates an inability to operate the inhalation device after training.
- History or presence of any drug or food allergies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Safety and Pharmacokinetics Trial of Inhaled Niclosamide in Healthy Adult Subjects
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of Niclosamide Inhalation Powder versus placebo (SAD part) and escalating multiple doses of Niclosamide Inhalation Powder versus placebo (MAD part). SAD part will be initiated first and includes a sentinel design. MAD part will not utilize a sentinel design unless the data monitoring committee requests the addition of sentinels. The MAD part will be initiated once the lowest doses from SAD part are deemed safe.
Read the detailed description
This is a Phase 1, randomized, 2 part double-blind, placebo-controlled trial to evaluate the safety and PK profiles of Niclosamide Inhalation Powder in a SAD/MAD study design.
Part A is a double-blinded, placebo-controlled, randomized, dose- ranging single dose study evaluating four different dose levels.
On Day 1 of each group, two selected subjects (sentinel subjects) will receive either Niclosamide Inhalation Powder or a matching placebo. Blood samples and safety measurements including Adverse Events (AEs) will be collected over 24 hour period following the drug administration. The safety results to be evaluated include AEs, concomitant medications, out of specification clinical laboratory results, vital signs, Electrocardiograms (ECGs), visual examinations, pulmonary function tests, pulse oximetry results and any new findings on physical examinations. If the administration is safe as deemed by Principal Investigator \& Medical Monitor, the remaining six subjects will be dosed (5 dosed with Niclosamide Inhalation Powder and 1 dosed with matching placebo), with identical safety and PK procedures performed after minimum of 2 days interval. A minimum of 3 days will separate each dose escalation, with the remaining dose groups dosed in a sentinel fashion.
Part B is a double-blinded, placebo-controlled, randomized, dose- ranging multi-dose study evaluating two different dose levels. Dose level 1 of Part B can begin once the data monitoring committee reviews the safety data and indicates safety is present. Niclosamide Inhalation Powder will be administered twice daily (BID) × 9 doses. Blood samples for safety and PK will be collected throughout confinement, which is 7 days.
- Conditions
- Healthy
- Being tested
- Niclosamide Inhalation Powder, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niclosamide Inhalation PowderDrug
Investigational drug will be supplied as capsules, each capsule contains 0.25 mg or 1 mg of Niclosamide Inhalation Powder. The capsules will be administered with the provided breath actuated Plastiape RS00 Model 8 Dry Powder Inhaler device.
PlaceboDrug
Placebo will be supplied as capsules, each capsule will contain no active ingredient. The capsules will be administered with the provided breath actuated Plastiape RS00 Model 8 Dry Powder Inhaler device.
| Study group | Role | What they receive |
|---|---|---|
| Drug: Niclosamide Inhalation Powder | Experimental | PART A (SAD): Niclosamide Inhalation Powder will be supplied as one to six capsules. Each capsule contains either 0.25 mg or 1 mg of Niclosamide Inhalation Powder and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 20-minute period.
SAD subjects will receive a single dose of study medication. Subjects in Cohort 1 will receive 0.5 mg, Cohort 2: 2 mg, Cohort 3: 6 mg.
PART B (MAD): Niclosamide Inhalation Powder will be supplied as one to six capsules. Each capsule contains either 0.25 mg or 1 mg of Niclosamide Inhalation Powder and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 20-minute period.
MAD subjects will receive Niclosamide Inhalation Powder BID for a total of 9 doses. Subjects in Cohort 4 will receive 3 mg BID, Cohort 5: 6 mg BID. Receives: Drug: Niclosamide Inhalation Powder |
| Drug: Placebo | Placebo comparator | PART A (SAD): Placebo will be supplied as one to six capsules. Each capsule contains Placebo inhalation powder and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 20-minute period.
SAD subjects (Part A) will receive a single dose of Placebo.
PART B (MAD): Placebo inhalation powder will be supplied as one to six capsules. Each capsule contains Placebo inhalation powder and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 20-minute period.
MAD subjects (Part B) will receive Placebo inhalation powder BID for a total of 9 doses. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience Adverse Events (AEs), Serious Adverse Events (SAEs) and withdrawals due to AEs
Number of AEs, SAEs, and discontinuation due to AEs
Measured: Baseline through study completion, up to 43 days
Number of participants who experience vital sign abnormalities
Number of participants with potentially clinically significant vital sign values
Measured: Baseline through study completion, up to 43 days
Number of participants who experience pulse oximetry abnormalities
Number of participants with potentially clinically significant pulse oximetry values
Measured: Baseline through study completion, up to 43 days
Mean change from baseline in forced expiratory volume (FEV1)
Spirometry used to measure FEV1 lung function
Measured: Baseline through study completion, up to 43 days
Mean change from baseline in forced vital capacity (FVC)
Spirometry used to measure FVC lung function
Measured: Baseline through study completion, up to 43 days
Mean change from baseline in FEV1/FVC ratio
Spirometry used to measure FEV1 and FVC lung function
Measured: Baseline through study completion, up to 43 days
Mean change from baseline in QTcF changes via ECG
Number of participants with potentially clinically significant ECG values
Measured: Baseline through study completion, up to 43 days
Number of participants who experience physical examination abnormalities
Number of participants with potentially clinically significant physical examination findings
Measured: Baseline through study completion, up to 43 days
Number of participants who experience laboratory test abnormalities
Number of participants with potentially clinically significant laboratory test results
Measured: Baseline through study completion, up to 43 days
Secondary outcomes (13)
PK of Niclosamide in plasma: Area under the plasma-concentration time curve (AUC)
Blood samples will be collected for plasma analysis
Measured: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-tlast)
Blood samples will be collected for analysis
Measured: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Maximum observed concentration (Cmax)
Blood samples will be collected for analysis
Measured: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Trough or minimum concentration (Ctrough)
Blood samples will be collected for analysis
Measured: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Concentration at the end of the dosing interval (Ct)
Blood samples will be collected for analysis
Measured: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Time to maximal observed concentration (tmax)
Blood samples will be collected for analysis
Measured: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Accumulation ratio (comparing Day 5 Cmax to Day 1 Cmax)
Blood samples will be collected for analysis
Measured: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Accumulation ratio (comparing Day 5 AUCtau to Day 1 AUC0-12)
Blood samples will be collected for analysis
Measured: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Area under the plasma-concentration time curve over the first 12 hours after dosing (AUC0-12)
Blood samples will be collected for analysis
Measured: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Area under the concentration time curve from time 0 extrapolated to infinity (AUC∞)
Blood samples will be collected for analysis
Measured: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Termination elimination half-life (t½)
Blood samples will be collected for analysis
Measured: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Apparent total body clearance (CL/F)
Blood samples will be collected for analysis
Measured: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Apparent volume of distribution during the terminal elimination phase (Vz/F)
Blood samples will be collected for analysis
Measured: Baseline through study completion, up to 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start14 Nov 2021
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part A: Eight (8) subjects will participate in each of the 3 dose escalations. Subjects will be randomized to receive either Niclosamide Inhalation Powder or placebo by inhalation (6 active, 2 placebo per group of 8). Part B: Eight (8) subjects will participate in each of the 2 dose escalations. Subjects will be randomized to receive either Niclosamide Inhalation Powder or placebo by inhalation (6 active, 2 placebo per group of 8).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TFF Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dale Christensen, PhD, Study director, TFF Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168644
- Sponsor's protocol ID
- TFF-N1-001
- Status last verified
- Feb 2022
- First submitted
- 20 Dec 2021
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Safety and Pharmacokinetics Trial of Inhaled Niclosamide in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05168644
- Acronym / sponsor ID
- TFF-N1-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TFF Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of Niclosamide Inhalation Powder versus placebo (SAD part) and escalating multiple doses of Niclosamide Inhalation Powder versus placebo (MAD part). SAD part will be initiated first and includes a sentinel design. MAD part will not utilize a sentinel design unless the data monitoring committee requests the addition of sentinels. The MAD part will be initiated once the lowest doses from SAD part are deemed safe.
Detailed description
This is a Phase 1, randomized, 2 part double-blind, placebo-controlled trial to evaluate the safety and PK profiles of Niclosamide Inhalation Powder in a SAD/MAD study design.
Part A is a double-blinded, placebo-controlled, randomized, dose- ranging single dose study evaluating four different dose levels.
On Day 1 of each group, two selected subjects (sentinel subjects) will receive either Niclosamide Inhalation Powder or a matching placebo. Blood samples and safety measurements including Adverse Events (AEs) will be collected over 24 hour period following the drug administration. The safety results to be evaluated include AEs, concomitant medications, out of specification clinical laboratory results, vital signs, Electrocardiograms (ECGs), visual examinations, pulmonary function tests, pulse oximetry results and any new findings on physical examinations. If the administration is safe as deemed by Principal Investigator \& Medical Monitor, the remaining six subjects will be dosed (5 dosed with Niclosamide Inhalation Powder and 1 dosed with matching placebo), with identical safety and PK procedures performed after minimum of 2 days interval. A minimum of 3 days will separate each dose escalation, with the remaining dose groups dosed in a sentinel fashion.
Part B is a double-blinded, placebo-controlled, randomized, dose- ranging multi-dose study evaluating two different dose levels. Dose level 1 of Part B can begin once the data monitoring committee reviews the safety data and indicates safety is present. Niclosamide Inhalation Powder will be administered twice daily (BID) × 9 doses. Blood samples for safety and PK will be collected throughout confinement, which is 7 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Part A: Eight (8) subjects will participate in each of the 3 dose escalations. Subjects will be randomized to receive either Niclosamide Inhalation Powder or placebo by inhalation (6 active, 2 placebo per group of 8). Part B: Eight (8) subjects will participate in each of the 2 dose escalations. Subjects will be randomized to receive either Niclosamide Inhalation Powder or placebo by inhalation (6 active, 2 placebo per group of 8).
| Arm | Type | Receives |
|---|---|---|
| Drug: Niclosamide Inhalation Powder | Experimental | Drug: Niclosamide Inhalation PowderPART A (SAD): Niclosamide Inhalation Powder will be supplied as one to six capsules. Each capsule contains either 0.25 mg or 1 mg of Niclosamide Inhalation Powder and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 20-minute period. SAD subjects will receive a single dose of study medication. Subjects in Cohort 1 will receive 0.5 mg, Cohort 2: 2 mg, Cohort 3: 6 mg. PART B (MAD): Niclosamide Inhalation Powder will be supplied as one to six capsules. Each capsule contains either 0.25 mg or 1 mg of Niclosamide Inhalation Powder and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 20-minute period. MAD subjects will receive Niclosamide Inhalation Powder BID for a total of 9 doses. Subjects in Cohort 4 will receive 3 mg BID, Cohort 5: 6 mg BID. |
| Drug: Placebo | Placebo comparator | Drug: PlaceboPART A (SAD): Placebo will be supplied as one to six capsules. Each capsule contains Placebo inhalation powder and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 20-minute period. SAD subjects (Part A) will receive a single dose of Placebo. PART B (MAD): Placebo inhalation powder will be supplied as one to six capsules. Each capsule contains Placebo inhalation powder and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 20-minute period. MAD subjects (Part B) will receive Placebo inhalation powder BID for a total of 9 doses. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Agree to use acceptable contraception or is not able to bear children.
- Body mass index (BMI) within ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2 at Screening (body weight of at least 50.0 kg and no more than120 kg at Screening).
- Non-smoker or ex-smoker (stopped using nicotine products for at least 12 months prior to the first study drug administration and throughout the study).
- Have no clinically significant diseases, including asthma, captured in the medical history or on the physical examination, visual examination, clinical laboratory assessments, and/or ECG.
- A forced expiratory volume during the first second (FEV1) ≥ 80% at Screening and Check-in.
Key exclusion criteria (20 listed)
- Female who is lactating, is pregnant or planning to become pregnant according to the pregnancy test at Screening or prior to the first study drug administration.
- Is mentally or legally incapacitated or unable to provide informed consent.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first study drug administration.
- History or presence of hypersensitivity or idiosyncratic reaction to niclosamide or any portion of the placebo.
- Has had surgery or any medical condition within 6 months prior to first study drug administration which may affect the absorption, distribution, metabolism, or elimination of the study drug, in the opinion of the PI or designee.
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 |
|---|---|---|
| Niclosamide Inhalation PowderInvestigational drug will be supplied as capsules, each capsule contains 0.25 mg or 1 mg of Niclosamide Inhalation Powder. The capsules will be administered with the provided breath actuated Plastiape RS00 Model 8 Dry Powder Inhaler device. | Drug | Drug: Niclosamide Inhalation Powder |
| PlaceboPlacebo will be supplied as capsules, each capsule will contain no active ingredient. The capsules will be administered with the provided breath actuated Plastiape RS00 Model 8 Dry Powder Inhaler device. | Drug | Drug: Placebo |
Primary outcome
Number of participants who experience Adverse Events (AEs), Serious Adverse Events (SAEs) and withdrawals due to AEs
Time frame: Baseline through study completion, up to 43 days
Number of AEs, SAEs, and discontinuation due to AEs
Number of participants who experience vital sign abnormalities
Time frame: Baseline through study completion, up to 43 days
Number of participants with potentially clinically significant vital sign values
Number of participants who experience pulse oximetry abnormalities
Time frame: Baseline through study completion, up to 43 days
Number of participants with potentially clinically significant pulse oximetry values
Mean change from baseline in forced expiratory volume (FEV1)
Time frame: Baseline through study completion, up to 43 days
Spirometry used to measure FEV1 lung function
Mean change from baseline in forced vital capacity (FVC)
Time frame: Baseline through study completion, up to 43 days
Spirometry used to measure FVC lung function
Mean change from baseline in FEV1/FVC ratio
Time frame: Baseline through study completion, up to 43 days
Spirometry used to measure FEV1 and FVC lung function
Mean change from baseline in QTcF changes via ECG
Time frame: Baseline through study completion, up to 43 days
Number of participants with potentially clinically significant ECG values
Number of participants who experience physical examination abnormalities
Time frame: Baseline through study completion, up to 43 days
Number of participants with potentially clinically significant physical examination findings
Number of participants who experience laboratory test abnormalities
Time frame: Baseline through study completion, up to 43 days
Number of participants with potentially clinically significant laboratory test results
13 secondary outcomes
PK of Niclosamide in plasma: Area under the plasma-concentration time curve (AUC)
Time frame: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-tlast)
Time frame: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Maximum observed concentration (Cmax)
Time frame: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Trough or minimum concentration (Ctrough)
Time frame: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Concentration at the end of the dosing interval (Ct)
Time frame: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Time to maximal observed concentration (tmax)
Time frame: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Accumulation ratio (comparing Day 5 Cmax to Day 1 Cmax)
Time frame: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Accumulation ratio (comparing Day 5 AUCtau to Day 1 AUC0-12)
Time frame: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Area under the plasma-concentration time curve over the first 12 hours after dosing (AUC0-12)
Time frame: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Area under the concentration time curve from time 0 extrapolated to infinity (AUC∞)
Time frame: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Termination elimination half-life (t½)
Time frame: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Apparent total body clearance (CL/F)
Time frame: Baseline through study completion, up to 43 days
PK of Niclosamide in plasma: Apparent volume of distribution during the terminal elimination phase (Vz/F)
Time frame: Baseline through study completion, up to 43 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Dale Christensen, PhD study director
TFF Pharmaceuticals
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 Inhalation Powder in people with Healthy, run by TFF Pharmaceuticals, Inc. at 1 site in Canada.
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 5 inclusion and 20 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 2 Feb 2022. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants who experience Adverse Events (AEs), Serious Adverse Events (SAEs) and withdrawals due to AEs (time frame: Baseline through study completion, up to 43 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2022.