COVID-19Phase 1NCT05453279
A Dose Escalation Phase 1 Study Evaluating the Safety and Pharmacokinetics of an Inhaled COVID-19 Inhibitor Delcetravir in Healthy Subjects
A Phase 1 study testing Delcetravir dry powder inhaler in people with COVID-19, run by Esfam Biotech Pty Ltd.
Trial summary
This study will be a single center, Phase I, randomized, double-blind, placebo controlled, single and multiple ascending dose (SAD/MAD) study evaluating the safety, tolerability, and PK of Delcetravir after administration via oral inhalation in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Delcetravir dry powder inhaler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Jan 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be included in the study:
- Male or female, non-smokers or casual smokers (defined as smoking the equivalent of less than an average of 5 cigarettes per week, and willing to abstain from smoking during involvement in the study), ≥18 and <50 (For Parts A and B) or ≥50 and ≤80 (for Parts C and D) years of age, with BMI >18.0 and <32.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
- Healthy as defined by:
- the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
- the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:
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- Simultaneous use of intra-uterine device placed at least 4 weeks prior to study drug administration, and condom for the male partner;
- Simultaneous use of hormonal contraceptives started at least 4 weeks prior to study drug administration and condom for the male partner.
- Sterile male partner (vasectomized since at least 6 months).
- Females of non-childbearing potential must be:
- Post-menopausal (defined as absence of menses for at least 12 months prior to the first study drug administration) with confirmation of the post menopausal status by documented FSH level greater than 40 mIU/mL; or
- Surgically sterile (complete hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation at least 6 months prior to the first study drug administration).
- Male subjects who are not vasectomized for at least 6 months, and who are sexually active with a female partner of childbearing potential (childbearing potential females are defined as women that are neither post-menopausal nor surgically sterile) must be willing to use one of the following acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration:
- Simultaneous use of a male condom and, for the female partner, hormonal contraceptives used since at least 4 weeks, or intra-uterine contraceptive device placed since at least 4 weeks;
- Male subjects who are sexually active with a same-sex partner must be willing to use a condom until study exit.
- Male and female subjects who practice abstinence from sexual intercourse as a usual and preferred lifestyle.
- Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
- Subjects with normal lung function defined as ≥80% predicted forced expiratory volume in one second (FEV1) at screening.
- Capable of consent.
Who cannot join
- 1) Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found during medical screening.
- 2) Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of check-in, or planned inpatient surgery or hospitalization during the study period.
- 3) Any history of malignancy or neoplastic disease
- Positive urine drug screen, urine cotinine test, or alcohol breath test at screening.
- History of significant allergic reactions (e.g., drug reaction, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
- Positive pregnancy test at screening.
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- Clinically significant ECG abnormalities (QTc greater than 450 ms) or vital sign abnormalities (systolic blood pressure less than 90 or greater than140 mmHg, diastolic blood pressure less than 40 or greater than 90 mmHg, or heart rate less than 40 or greater than100 bpm, oxygen saturation less than 95% O2) at screening.
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit. Regular use of alcohol is defined as greater than 14 units of alcohol per week, where 1 unit is defined as 375 mL of beer at 3.5% a/v, 100 mL of wine at 13.5% a/v, or 30 mL of spirit at 40% a/v.
- History of drug abuse within 1 year prior to screening, recreational use of soft drugs (such as tetrahydrocannabinol [THC]) within 1 month prior to the screening visit, or hard drugs (amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methyledioxymethamphetamine [MDMA], and phencyclidine [PCP]) within 3 months prior to screening.
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
- Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):
- Prescription medications (except for hormonal contraceptives) within 14 days prior to the first dosing;
- Over-the-counter products and natural health products (including herbal remedies, such as St. John's wort, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to the first dosing, with the exception of the occasional use of acetaminophen/paracetamol (up to 2 g/day), ibuprofen (up to 800 mg/day), and topical formulations without significant systemic absorption;
- Depot injection or implant (except for hormonal contraceptives) of any drug within 3 months prior to the first dosing.
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
- Breast-feeding subject.
- History of latent or active tuberculosis, or exposure to endemic areas within 8 weeks prior to QuantiFERON®-TB testing performed at screening.
- Positive QuantiFERON®-TB test indicating possible tuberculosis infection.
- Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the course of the study.
- Presence of fever (body temperature greater than 37.6 °C) e.g. a fever associated with a symptomatic viral or bacterial infection, within 2 weeks prior to the first dosing.
- Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single and Multiple Dose Escalation First-In-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Delcetravir Administered Via Inhalation in Healthy Subjects
This study will be a single center, Phase I, randomized, double-blind, placebo controlled, single and multiple ascending dose (SAD/MAD) study evaluating the safety, tolerability, and PK of Delcetravir after administration via oral inhalation in healthy subjects.
Read the detailed description
Primary objectives:
- To evaluate the safety and tolerability of single and multiple doses of Delcetravir in healthy subjects (18-50 years of age).
- To evaluate the safety and tolerability of single and multiple doses of Delcetravir in healthy subjects (50-80 years of age).
- To evaluate the pharmacokinetics (PK) of Delcetravir after single and multiple doses of ESFAM289 in healthy subjects (18-50 years of age).
- To evaluate the PK of Delcetravir after single and multiple doses of Delcetravir in healthy subjects (50-80 years of age)
Secondary objectives:
- To compare the PK of Delcetravir after single and multiple doses of Delcetravir in age stratified subjects (18-50 vs. 50-80 years of age).
- To compare the safety and tolerability after single and multiple doses of Delcetravir in age stratified subjects (18-50 vs. 50-80 years of age).
- Conditions
- COVID-19
- Being tested
- Delcetravir dry powder inhaler
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delcetravir dry powder inhalerCombination product
Placebo dry powder inhaler
| Study group | Role | What they receive |
|---|---|---|
| Active (experimental) | Active comparator | Delcetravir inhalation via dry powder inhaler device administered up to 4 single ascending doses. According to tolerability of single ascending doses, delcetravir is then given as inhalation via dry powder device in multiple ascending doses, once daily for 7 days. Receives: Combination Product: Delcetravir dry powder inhaler |
| Placebo comparator | Placebo comparator | Placebo inhaler, identical in appearance to the active comparator, administered doses up to 4 single ascending doses. According to tolerability of single ascending doses, placebo doses are then given as inhalation via dry powder device in multiple ascending doses, once daily for 7 days. Receives: Combination Product: Delcetravir dry powder inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with chest pain after single and multiple ascending doses of active and placebo comparator
Symptoms of chest pain
Measured: 22 days
Number of subjects with shortness of breath after single and multiple ascending doses of active and placebo comparator
Symptoms of shortness of breath
Measured: 22 days
Number of subjects with cough after single and multiple ascending doses of active and placebo comparator
Symptoms of cough
Measured: 22 days
Number of subjects with sputum production after single and multiple ascending doses of active and placebo comparator
Symptoms of sputum production
Measured: 22 days
Hemoglobin assessment after active comparator and placebo.
Hemoglobin in g/L
Measured: 22 days
White cell count assessment after active comparator and placebo.
White cell count differential in 109/L
Measured: 22 days
Platelet count assessment after active comparator and placebo.
Platelet count in 109/L
Measured: 22 days
Laboratory meaurement of sodium concentration after active comparator and placebo.
Serum sodium in mmol/L
Measured: 22 days
Laboratory measurement of potassium concentration after active comparator and placebo.
Serum potassium in mmol/L
Measured: 22 days
Laboratory measurement of bicarbonate concentration after active comparator and placebo.
Serum bicarbonate in mmol/L
Measured: 22 days
Laboratory measurement of urea concentration after active comparator and placebo.
Serum urea in mmol/L
Measured: 22 days
Laboratory measurement of creatinine concentration after active comparator and placebo.
Serum creatinine in umol/L
Measured: 22 days
Laboratory measurement of ALT concentration after active comparator and placebo.
Serum ALT in U/L
Measured: 22 days
Laboratory measurement of AST concentration after active comparator and placebo.
Serum AST in U/L
Measured: 22 days
Laboratory measurement of alkaline phosphatase concentration after active comparator and placebo.
Serum alkaline phosphatase in U/L
Measured: 22 days
Heart rate after active comparator and placebo.
Heart rate in beats per minute
Measured: 22 days
Blood pressure after active comparator and placebo.
Systolic and diastolic blood pressure in mmHg
Measured: 22 days
Respiratory rate after active comparator and placebo.
Respiratory rate in breaths per minute
Measured: 22 days
Pulse oximetry measurement after active comparator and placebo.
Pulse oximetry in blood oxygen saturation
Measured: 22 days
ECG after active comparator and placebo.
PR interval, QRS complex, QTc interval
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Model description
- This study will be a single center, Phase I, randomized, double-blind, placebo controlled, single and multiple ascending dose (SAD/MAD) study evaluating safety, tolerability, and PK after administration via oral inhalation in healthy subjects.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esfam Biotech Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albert G Frauman, MD, Study director, Esfam Biotech Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453279
- Sponsor's protocol ID
- COV0001
- Status last verified
- Jul 2022
- First submitted
- 1 Jun 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single and Multiple Dose Escalation First-In-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Delcetravir Administered Via Inhalation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05453279
- Acronym / sponsor ID
- COV0001
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Esfam Biotech Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 12 Jul 2022 (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 study will be a single center, Phase I, randomized, double-blind, placebo controlled, single and multiple ascending dose (SAD/MAD) study evaluating the safety, tolerability, and PK of Delcetravir after administration via oral inhalation in healthy subjects.
Detailed description
Primary objectives:
- To evaluate the safety and tolerability of single and multiple doses of Delcetravir in healthy subjects (18-50 years of age).
- To evaluate the safety and tolerability of single and multiple doses of Delcetravir in healthy subjects (50-80 years of age).
- To evaluate the pharmacokinetics (PK) of Delcetravir after single and multiple doses of ESFAM289 in healthy subjects (18-50 years of age).
- To evaluate the PK of Delcetravir after single and multiple doses of Delcetravir in healthy subjects (50-80 years of age)
Secondary objectives:
- To compare the PK of Delcetravir after single and multiple doses of Delcetravir in age stratified subjects (18-50 vs. 50-80 years of age).
- To compare the safety and tolerability after single and multiple doses of Delcetravir in age stratified subjects (18-50 vs. 50-80 years of age).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study will be a single center, Phase I, randomized, double-blind, placebo controlled, single and multiple ascending dose (SAD/MAD) study evaluating safety, tolerability, and PK after administration via oral inhalation in healthy subjects.
| Arm | Type | Receives |
|---|---|---|
| Active (experimental) | Active comparator | Combination Product: Delcetravir dry powder inhalerDelcetravir inhalation via dry powder inhaler device administered up to 4 single ascending doses. According to tolerability of single ascending doses, delcetravir is then given as inhalation via dry powder device in multiple ascending doses, once daily for 7 days. |
| Placebo comparator | Placebo comparator | Combination Product: Delcetravir dry powder inhalerPlacebo inhaler, identical in appearance to the active comparator, administered doses up to 4 single ascending doses. According to tolerability of single ascending doses, placebo doses are then given as inhalation via dry powder device in multiple ascending doses, once daily for 7 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female, non-smokers or casual smokers (defined as smoking the equivalent of less than an average of 5 cigarettes per week, and willing to abstain from smoking during involvement in the study), ≥18 and <50 (For Parts A and B) or ≥50 and ≤80 (for Parts C and D) years of age, with BMI >18.0 and <32.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
- Healthy as defined by:
- Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:
- Females of non-childbearing potential must be:
- Male subjects who are not vasectomized for at least 6 months, and who are sexually active with a female partner of childbearing potential (childbearing potential females are defined as women that are neither post-menopausal nor surgically sterile) must be willing to use one of the following acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration:
Key exclusion criteria (21 listed)
- 1) Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found during medical screening.
- 2) Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of check-in, or planned inpatient surgery or hospitalization during the study period.
- 3) Any history of malignancy or neoplastic disease
- Positive urine drug screen, urine cotinine test, or alcohol breath test at screening.
- History of significant allergic reactions (e.g., drug reaction, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
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 |
|---|---|---|
| Delcetravir dry powder inhalerPlacebo dry powder inhaler | Combination product | Active (experimental), Placebo comparator |
Primary outcome
Number of subjects with chest pain after single and multiple ascending doses of active and placebo comparator
Time frame: 22 days
Symptoms of chest pain
Number of subjects with shortness of breath after single and multiple ascending doses of active and placebo comparator
Time frame: 22 days
Symptoms of shortness of breath
Number of subjects with cough after single and multiple ascending doses of active and placebo comparator
Time frame: 22 days
Symptoms of cough
Number of subjects with sputum production after single and multiple ascending doses of active and placebo comparator
Time frame: 22 days
Symptoms of sputum production
Hemoglobin assessment after active comparator and placebo.
Time frame: 22 days
Hemoglobin in g/L
White cell count assessment after active comparator and placebo.
Time frame: 22 days
White cell count differential in 109/L
Platelet count assessment after active comparator and placebo.
Time frame: 22 days
Platelet count in 109/L
Laboratory meaurement of sodium concentration after active comparator and placebo.
Time frame: 22 days
Serum sodium in mmol/L
Laboratory measurement of potassium concentration after active comparator and placebo.
Time frame: 22 days
Serum potassium in mmol/L
Laboratory measurement of bicarbonate concentration after active comparator and placebo.
Time frame: 22 days
Serum bicarbonate in mmol/L
Laboratory measurement of urea concentration after active comparator and placebo.
Time frame: 22 days
Serum urea in mmol/L
Laboratory measurement of creatinine concentration after active comparator and placebo.
Time frame: 22 days
Serum creatinine in umol/L
Laboratory measurement of ALT concentration after active comparator and placebo.
Time frame: 22 days
Serum ALT in U/L
Laboratory measurement of AST concentration after active comparator and placebo.
Time frame: 22 days
Serum AST in U/L
Laboratory measurement of alkaline phosphatase concentration after active comparator and placebo.
Time frame: 22 days
Serum alkaline phosphatase in U/L
Heart rate after active comparator and placebo.
Time frame: 22 days
Heart rate in beats per minute
Blood pressure after active comparator and placebo.
Time frame: 22 days
Systolic and diastolic blood pressure in mmHg
Respiratory rate after active comparator and placebo.
Time frame: 22 days
Respiratory rate in breaths per minute
Pulse oximetry measurement after active comparator and placebo.
Time frame: 22 days
Pulse oximetry in blood oxygen saturation
ECG after active comparator and placebo.
Time frame: 22 days
PR interval, QRS complex, QTc interval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 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.
Albert G Frauman, MD study director
Esfam Biotech Pty Ltd
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Delcetravir dry powder inhaler in people with COVID-19, run by Esfam Biotech Pty Ltd.
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 19 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albert G Frauman, MD (+61 416198042, albert@esfambiotech.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with chest pain after single and multiple ascending doses of active and placebo comparator (time frame: 22 days). The study lists 20 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 12 Jul 2022.