Nasal Decolonization of Staphylococcus AureusPhase 1/2NCT04767321
A Study to Evaluate the Safety and Efficacy of 3% LTX-109 for Nasal Decolonisation of Staphylococcus
A Phase 1/2 study testing LTX-109 gel, 3% w/w in people with Nasal Decolonization of Staphylococcus Aureus, run by Pharma Holdings AS at 1 site in Sweden.
Trial summary
A Phase I/IIa, double-blind, placebo-controlled, randomised study designed to evaluate the safety, tolerability, exploratory efficacy and exposure of LTX-109 administered topically to the anterior nares in subjects with persistent carriage of S. aureus (methicillin-susceptible S. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Decolonization of Staphylococcus Aureus
- What is being tested?
- LTX-109 gel, 3% w/w
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 22 Feb 2021to 1 Jun 2021
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent for participation in the study.
- Male or female subject aged 18 to 65 years inclusive at Visit 2.
- Persistent nasal carrier of Staphylococcus aureus (MSSA and/or MRSA), confirmed by two positive bacterial cultures from the nose during the screening period.
- Clinically normal medical history, physical findings, vital signs and laboratory values at the time of screening Visit 2, as judged by the Investigator.
- Women of child bearing potential (WOCBP) must practice abstinence (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD]or intrauterine hormone-releasing system [IUS]) from at least 2 weeks prior to dose to 2 weeks after last dose. Female subjects must refrain from donating eggs from the date of dosing until 3 months after dosing with the IMP. Their male partner must agree to use a condom during the same time frame if he has not undergone vasectomy.
- Women of non-childbearing potential are defined as pre-menopausal females who are sterilised (tubal ligation or permanent bilateral occlusion of fallopian tubes); or females who have undergone hysterectomy or bilateral oophorectomy; or post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with simultaneous detection of follicle stimulating hormone [FSH] 25-140 IE/L is confirmatory).
- Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP. Their female partner of child-bearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see above).
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Severe eczema or skin wounds, dry or sensitive skin assessed as clinically significant by the Investigator.
- Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
- Any positive result at screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to LTX-109 or chlorhexidine.
Show all 23Show fewer
- S. aureus (MSSA and/or MRSA) decolonisation attempt in the 6 months prior to screening Visit 2.
- Inability to take medications nasally.
- Nasal polyps or significant anatomical nasal abnormality, as judged by the Investigator.
- Evidence of open wound, lesion, inflammation, erythema or infection (including active rhinitis, sinusitis or upper respiratory infection) affecting the nostril area, lip and skin close to the nose.
- History of multiple episodes (>3) of epistaxis within 12 months prior to screening Visit 2.
- Disease in the region of the application sites, significant history of trauma or skin disease in the region of the application sites, current nasal skin or nasal septum condition requiring treatment or nasal surgery in the 6 months prior to screening Visit 2.
- In situ nasal jewellery or open nasal piercings.
- Previous or concurrent treatment with antimicrobials for an infection within the last 30 days prior to the first administration of IMP.
- Regular use of cortisone or anticoagulation medication within 14 days prior to the first administration of IMP and regular use of nasal decongestants within 30 days prior to the first IMP administration, at the discretion of the Investigator.
- Planned treatment or treatment with another investigational drug within 30 days prior to Day 1. Subjects consented and screened but not dosed in previous Phase I studies are not excluded.
- Positive screen for drugs of abuse or alcohol at screening Visit 2 or on admission to the unit prior to administration of the IMP.
- History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- Presence or history of drug abuse, as judged by the Investigator.
- History of, or current use of, anabolic steroids.
- Plasma donation within 2 weeks of screening Visit 2 or blood donation (or corresponding blood loss) during the three months prior to screening.
- Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
- Female subjects who are pregnant or who are currently breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/IIa, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Exploratory Efficacy of 3% LTX-109 Compared to Placebo for Nasal Decolonisation of Staphylococcus Aureus
A Phase I/IIa, double-blind, placebo-controlled, randomised study designed to evaluate the safety, tolerability, exploratory efficacy and exposure of LTX-109 administered topically to the anterior nares in subjects with persistent carriage of S. aureus (methicillin-susceptible S. aureus [MSSA] and/or methicillin-resistant S. aureus [MRSA]).
Read the detailed description
Approximately 60 subjects will be screened to achieve 24 persistent MSSA and/or MRSA carriers and 16 randomised and dosed subjects randomized 3:1, active to placebo.
Eligible subjects will be admitted to the clinic on Day 1 for randomisation and dosing and will remain at the clinic until Day 2. Following nasal and perineum swabs and a chlorhexidine (Hibiscrub®) shower, the investigational medicinal product (IMP) will be applied topically to both nostrils by a qualified health professional 4 times during a six hour period (every two hours at 0, 2, 4 and 6 hours) on Day 1.
Subjects will come back to the research clinic on Day 3, Day 4, Day 8 and Day 15 (Visits 4 to 7) for safety, tolerability and efficacy assessments and for blood sampling for bioanalysis. On Day 5 and Day 6, subjects will take a chlorhexidine shower at home. A final end-of-study visit (Visit 8) will take place on Day 22 (±3 days) or after early withdrawal.
All subjects will be instructed to wash the body and hair with chlorhexidine body wash and shampoo at the clinic on Day 1 (prior to the first dose) and on Day 2. Prior to leaving the clinic on Day 2, subjects will be provided with chlorhexidine body wash and shampoo for body and hair wash at home on Day 3 (prior to Visit 4), on Day 4 (prior to Visit 5) and on Day 5 and Day 6.
Each subject is expected to participate in the study for approximately 50 days including a 28 day screening period
- Being tested
- LTX-109 gel, 3% w/w, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTX-109 gel, 3% w/wDrug
LTX-109 gel will be applied topically to both nostrils by a qualified health professional. On each dosing occasion, a large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.
PlaceboDrug
Placebo gel will be applied topically to both nostrils by a qualified health professional. On each dosing occasion, a large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.
| Study group | Role | What they receive |
|---|---|---|
| LTX-109 treatment | Experimental | Nasal application of LTX-109 gel 3% (w/w), 250 mikroliters in each nostril, 4 times in one day, every two hours. Receives: Drug: LTX-109 gel, 3% w/w |
| Placebo | Experimental | Nasal application of placebo, 250 mikroliters in each nostril, 4 times in one day, every two hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety by occurence and frequency of Adverse Events
Occurrence and frequency of Adverse Events
Measured: Through treatment and followup of 22 days
Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point graded scale.
Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)
Measured: Day 1
Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point graded scale.
Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)
Measured: Day 2
Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.
Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)
Measured: Day 3
Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.
Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)
Measured: Day 4
Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.
Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)
Measured: Day 8
Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.
Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)
Measured: Day 15
Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.
Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)
Measured: Day 22
Local tolerability assessed by the subject by Visual Analog Scale.
Assessment of Local tolerability on Visual Analog Scale
Measured: Day 1
Local tolerability assessed by the subject by Visual Analog Scale.
Assessment of Local tolerability on Visual Analog Scale
Measured: Day 2
Secondary outcomes (5)
Number of subjects on LTX-109 versus placebo with bacterial eradication at Test of Cure
Assessment of eradication of bacteria defined as non-presence of Staphylococcus aureus (MSSA and/or MRSA) in quantitative cultures
Measured: 54 hours (+ 2 hours)
Number of subjects on LTX-109 versus placebo with bacterial eradication at other specified time points than Time of Cure.
Assessment of bacterial count at specified points in time to explore effect of the intervention
Measured: 4, 6, 12, 24, 78 hours and Days 8, 15 and 22
Number of colony forming units (CFUs) in subjects on LTX-109 versus placebo at specified points in time.
Assessment of bacterial count at specified points in time to explore effect of the intervention
Measured: 4, 6, 12, 24, 78 hours and Days 8, 15 and 22
Number of subjects on LTX-109 vs placebo with bacterial recolonisation defined as the timepoint of recurrence of colonisation after confirmed eradication.
Assessment of recurrence
Measured: Days 4, 8, 15 and 22
Plasma concentrations of LTX-109
Assessment of plasma concentratin by analysis of blood samples
Measured: 6, 24, 54 and 78 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start22 Feb 2021
- Primary completion23 Mar 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Decolonization of Staphylococcus AureusStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, Double-blind, Placebo-controlled Randomization 3:1, active to placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharma Holdings AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
- Investigators
- Johan Nilsson, MD, Principal investigator, CTC Clinical Trial Consultants AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767321
- Sponsor's protocol ID
- C20-109-06
- Status last verified
- Feb 2021
- First submitted
- 12 Feb 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- 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 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Exploratory Efficacy of 3% LTX-109 Compared to Placebo for Nasal Decolonisation of Staphylococcus Aureus
- ClinicalTrials.gov ID
- NCT04767321
- Acronym / sponsor ID
- C20-109-06
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Pharma Holdings ASIndustry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 23 Feb 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.
A Phase I/IIa, double-blind, placebo-controlled, randomised study designed to evaluate the safety, tolerability, exploratory efficacy and exposure of LTX-109 administered topically to the anterior nares in subjects with persistent carriage of S. aureus (methicillin-susceptible S. aureus [MSSA] and/or methicillin-resistant S. aureus [MRSA]).
Detailed description
Approximately 60 subjects will be screened to achieve 24 persistent MSSA and/or MRSA carriers and 16 randomised and dosed subjects randomized 3:1, active to placebo.
Eligible subjects will be admitted to the clinic on Day 1 for randomisation and dosing and will remain at the clinic until Day 2. Following nasal and perineum swabs and a chlorhexidine (Hibiscrub®) shower, the investigational medicinal product (IMP) will be applied topically to both nostrils by a qualified health professional 4 times during a six hour period (every two hours at 0, 2, 4 and 6 hours) on Day 1.
Subjects will come back to the research clinic on Day 3, Day 4, Day 8 and Day 15 (Visits 4 to 7) for safety, tolerability and efficacy assessments and for blood sampling for bioanalysis. On Day 5 and Day 6, subjects will take a chlorhexidine shower at home. A final end-of-study visit (Visit 8) will take place on Day 22 (±3 days) or after early withdrawal.
All subjects will be instructed to wash the body and hair with chlorhexidine body wash and shampoo at the clinic on Day 1 (prior to the first dose) and on Day 2. Prior to leaving the clinic on Day 2, subjects will be provided with chlorhexidine body wash and shampoo for body and hair wash at home on Day 3 (prior to Visit 4), on Day 4 (prior to Visit 5) and on Day 5 and Day 6.
Each subject is expected to participate in the study for approximately 50 days including a 28 day screening period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomised, Double-blind, Placebo-controlled Randomization 3:1, active to placebo
| Arm | Type | Receives |
|---|---|---|
| LTX-109 treatment | Experimental | Drug: LTX-109 gel, 3% w/wNasal application of LTX-109 gel 3% (w/w), 250 mikroliters in each nostril, 4 times in one day, every two hours. |
| Placebo | Experimental | Drug: PlaceboNasal application of placebo, 250 mikroliters in each nostril, 4 times in one day, every two hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to give written informed consent for participation in the study.
- Male or female subject aged 18 to 65 years inclusive at Visit 2.
- Persistent nasal carrier of Staphylococcus aureus (MSSA and/or MRSA), confirmed by two positive bacterial cultures from the nose during the screening period.
- Clinically normal medical history, physical findings, vital signs and laboratory values at the time of screening Visit 2, as judged by the Investigator.
- Women of child bearing potential (WOCBP) must practice abstinence (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD]or intrauterine hormone-releasing system [IUS]) from at least 2 weeks prior to dose to 2 weeks after last dose. Female subjects must refrain from donating eggs from the date of dosing until 3 months after dosing with the IMP. Their male partner must agree to use a condom during the same time frame if he has not undergone vasectomy.
Key exclusion criteria (23 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Severe eczema or skin wounds, dry or sensitive skin assessed as clinically significant by the Investigator.
- Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
- Any positive result at screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
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 |
|---|---|---|
| LTX-109 gel, 3% w/wLTX-109 gel will be applied topically to both nostrils by a qualified health professional. On each dosing occasion, a large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril. | Drug | LTX-109 treatment |
| PlaceboPlacebo gel will be applied topically to both nostrils by a qualified health professional. On each dosing occasion, a large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril. | Drug | Placebo |
Primary outcome
Assessment of safety by occurence and frequency of Adverse Events
Time frame: Through treatment and followup of 22 days
Occurrence and frequency of Adverse Events
Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point graded scale.
Time frame: Day 1
Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)
Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point graded scale.
Time frame: Day 2
Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)
Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.
Time frame: Day 3
Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)
Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.
Time frame: Day 4
Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)
Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.
Time frame: Day 8
Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)
Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.
Time frame: Day 15
Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)
Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.
Time frame: Day 22
Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)
Local tolerability assessed by the subject by Visual Analog Scale.
Time frame: Day 1
Assessment of Local tolerability on Visual Analog Scale
Local tolerability assessed by the subject by Visual Analog Scale.
Time frame: Day 2
Assessment of Local tolerability on Visual Analog Scale
5 secondary outcomes
Number of subjects on LTX-109 versus placebo with bacterial eradication at Test of Cure
Time frame: 54 hours (+ 2 hours)
Number of subjects on LTX-109 versus placebo with bacterial eradication at other specified time points than Time of Cure.
Time frame: 4, 6, 12, 24, 78 hours and Days 8, 15 and 22
Number of colony forming units (CFUs) in subjects on LTX-109 versus placebo at specified points in time.
Time frame: 4, 6, 12, 24, 78 hours and Days 8, 15 and 22
Number of subjects on LTX-109 vs placebo with bacterial recolonisation defined as the timepoint of recurrence of colonisation after confirmed eradication.
Time frame: Days 4, 8, 15 and 22
Plasma concentrations of LTX-109
Time frame: 6, 24, 54 and 78 hours
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 30 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Nasal Decolonization of Staphylococcus Aureus
Active, not recruitingPhase 4
Nasal Decolonization of Dialysis Patients Noses
Staphylococcus Aureus Infection
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.
Johan Nilsson, MD principal investigator
CTC Clinical Trial Consultants AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LTX-109 gel, 3% w/w in people with Nasal Decolonization of Staphylococcus Aureus, run by Pharma Holdings AS at 1 site in Sweden.
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 7 inclusion and 23 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 30 Aug 2021. 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 Sweden. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Assessment of safety by occurence and frequency of Adverse Events (time frame: Through treatment and followup of 22 days). The study lists 10 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 30 Aug 2021.