COVID-19Phase 1NCT05840952
A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558
A Phase 1 study testing ALG-097558, Midazolam and Itraconazole in people with COVID-19, run by Aligos Therapeutics at 1 site in United Kingdom.
Trial summary
A multi-part study of ALG-097558 to evaluate safety, tolerability, pharmacokinetics and drug-drug interaction potential after single and multiple doses in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- ALG-097558, Midazolam and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jul 2023to 29 Apr 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and Female between 18 and 55 years old
- BMI 18.0 to 32.0 kg/m^2
- Female subjects must have a negative serum pregnancy test at screening
- Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria
Who cannot join
- Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
- Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
- Subjects with a history of clinically significant drug allergy
- Excessive use of alcohol defined as regular consumption of ≥14 units/week
- Unwilling to abstain from alcohol use for 1 week prior to start of the study through end of study follow up
- Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
- Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
Trial locations and contacts
1 site in 1 country.
About this study
A multi-part study of ALG-097558 to evaluate safety, tolerability, pharmacokinetics and drug-drug interaction potential after single and multiple doses in healthy volunteers
- Conditions
- COVID-19
- Being tested
- ALG-097558, Placebo, Midazolam, Itraconazole, Carbamazepine
- Keywords
- Healthy Volunteer
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALG-097558Drug
single or multiple doses of ALG-097558
PlaceboDrug
single or multiple doses of placebo
MidazolamDrug
Multiple doses of Midazolam
ItraconazoleDrug
Multiple doses of Itraconazole
CarbamazepineDrug
Multiple doses of Carbamazepine
ALG-097558 in solution formulationDrug
ALG-097558 in solution administered in fasted state
ALG-097558 in tablet formulationDrug
ALG-097558 in tablet administered in fasted and fed state
| Study group | Role | What they receive |
|---|---|---|
| ALG-097558 | Experimental | Oral doses of ALG-097558 in Healthy Volunteers, up to 20 doses over 10 days Receives: Drug: ALG-097558 |
| Placebo | Placebo comparator | Oral doses of placebo in Healthy Volunteers, up to 20 doses over 10 days Receives: Drug: Placebo |
| ALG-097558 and Midazolam | Experimental | Oral doses of ALG-097558, up to 14 doses over 7 days and oral dose of Midazolam, up to 2 doses, over 2 days, in Healthy Volunteers Receives: Drug: ALG-097558; Drug: Midazolam |
| ALG-097558, Placebo, and, Itraconazole | Experimental | Oral doses of placebo, up to 2 doses over 2 days, followed by ALG-097558, up to 2 doses over 2 days, and itraconazole up to 10 doses over 10 days, in Healthy Volunteers. Receives: Drug: ALG-097558; Drug: Placebo; Drug: Itraconazole |
| ALG-097558 and Carbamazepine | Experimental | Oral doses of ALG-097558, up to 2 doses over 2 days and oral doses of Carbamazepine, up to 30 doses, over 15 days, in Healthy Volunteers Receives: Drug: ALG-097558; Drug: Carbamazepine |
| ALG-097558 Bioavailability | Experimental | Oral doses of ALG-097558, up to 3 doses over 3 days, both solution and tablet formulations dosed in fasted state, and tablet formulation dosed in fed state, in Healthy Volunteers Receives: Drug: ALG-097558 in solution formulation; Drug: ALG-097558 in tablet formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: Up to 11 days for Part 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: Up to 20 days for Part 2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: Up to 20 days for Part 3
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: Up to 23 days for Part 4
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: Up to 28 days for Part 5
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: Up to 17 days for Part 6
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of Midazolam and applicable metabolites
Measured: Predose (-2 hours) up to 11 days
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of Midazolam and applicable metabolites
Measured: Predose (-2 hours) up to 11 days
Maximum plasma concentration [Cmax]
Pharmacokinetic parameters of Midazolam and applicable metabolites
Measured: Predose (-2 hours) up to 11 days
Minimum plasma concentration [Cmin]
Pharmacokinetic parameters of Midazolam and applicable metabolites
Measured: Predose (-2 hours) up to 11 days
C0 [predose]
Pharmacokinetic parameters of Midazolam and applicable metabolites
Measured: Predose (-2 hours) up to 11 days
Half-life [t1/2]
Pharmacokinetic parameters of Midazolam and applicable metabolites
Measured: Predose (-2 hours) up to 11 days
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Measured: Predose (-0.75 hours) up to 19 days
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Measured: Predose (-0.75 hours) up to 19 days
Maximum plasma concentration [Cmax]
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Measured: Predose (-0.75 hours) up to 19 days
Minimum plasma concentration [Cmin]
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Measured: Predose (-0.75 hours) up to 19 days
C0 [predose]
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Measured: Predose (-0.75 hours) up to 19 days
Half-life [t1/2]
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Measured: Predose (-0.75 hours) up to 19 days
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Measured: Predose (-0.75 hours) up to 9 days
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Measured: Predose (-0.75 hours) up to 9 days
Maximum plasma concentration [Cmax]
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Measured: Predose (-0.75 hours) up to 9 days
Minimum plasma concentration [Cmin]
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Measured: Predose (-0.75 hours) up to 9 days
C0 [predose]
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Measured: Predose (-0.75 hours) up to 9 days
Half-life [t1/2]
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Measured: Predose (-0.75 hours) up to 9 days
Secondary outcomes (7)
Maximum plasma concentration [Cmax]
Pharmacokinetic parameters of ALG-097558 in plasma
Measured: Predose (-0.75 hours) up to 19 days
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of ALG-097558 in plasma
Measured: Predose (-0.75 hours) up to 19 days
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of ALG-097558 in plasma
Measured: Predose (-0.75 hours) up to 19 days
Minimum plasma concentration [Cmin]
Pharmacokinetic parameters of ALG-097558 in plasma
Measured: Predose (-0.75 hours) up to 19 days
Half-life [t1/2]
Pharmacokinetic parameters of ALG-097558 in plasma
Measured: Predose (-0.75 hours) up to 19 days
C0 [predose]
Pharmacokinetic parameters of ALG-097558 in plasma
Measured: Predose (-0.75 hours) up to 19 days
Dose Proportionality
Pharmacokinetic parameters of ALG-097558 in plasma
Measured: Predose (-0.75 hours) up to 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start4 Jul 2023
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
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
- Parts 1 and 2 of the study are parallel assignment, with 2 arms. Parts 3, 5, and 6 are fixed sequence, crossover studies. Part 4 is a partially placebo-controlled, fixed sequence, crossover study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aligos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840952
- Sponsor's protocol ID
- ALG-097558-701
- Status last verified
- Sep 2024
- First submitted
- 10 Apr 2023
- Last updated
- 8 Apr 2025
- 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558
- ClinicalTrials.gov ID
- NCT05840952
- Acronym / sponsor ID
- ALG-097558-701
- Conditions
- COVID-19
- Keywords
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Aligos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 3 May 2023 (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 multi-part study of ALG-097558 to evaluate safety, tolerability, pharmacokinetics and drug-drug interaction potential after single and multiple doses in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Parts 1 and 2 of the study are parallel assignment, with 2 arms. Parts 3, 5, and 6 are fixed sequence, crossover studies. Part 4 is a partially placebo-controlled, fixed sequence, crossover study.
| Arm | Type | Receives |
|---|---|---|
| ALG-097558 | Experimental | Drug: ALG-097558Oral doses of ALG-097558 in Healthy Volunteers, up to 20 doses over 10 days |
| Placebo | Placebo comparator | Drug: PlaceboOral doses of placebo in Healthy Volunteers, up to 20 doses over 10 days |
| ALG-097558 and Midazolam | Experimental | Drug: ALG-097558, Drug: MidazolamOral doses of ALG-097558, up to 14 doses over 7 days and oral dose of Midazolam, up to 2 doses, over 2 days, in Healthy Volunteers |
| ALG-097558, Placebo, and, Itraconazole | Experimental | Drug: ALG-097558, Drug: Placebo, Drug: ItraconazoleOral doses of placebo, up to 2 doses over 2 days, followed by ALG-097558, up to 2 doses over 2 days, and itraconazole up to 10 doses over 10 days, in Healthy Volunteers. |
| ALG-097558 and Carbamazepine | Experimental | Drug: ALG-097558, Drug: CarbamazepineOral doses of ALG-097558, up to 2 doses over 2 days and oral doses of Carbamazepine, up to 30 doses, over 15 days, in Healthy Volunteers |
| ALG-097558 Bioavailability | Experimental | Drug: ALG-097558 in solution formulation, Drug: ALG-097558 in tablet formulationOral doses of ALG-097558, up to 3 doses over 3 days, both solution and tablet formulations dosed in fasted state, and tablet formulation dosed in fed state, in Healthy Volunteers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and Female between 18 and 55 years old
- BMI 18.0 to 32.0 kg/m^2
- Female subjects must have a negative serum pregnancy test at screening
- Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria
Key exclusion criteria (7 listed)
- Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
- Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
- Subjects with a history of clinically significant drug allergy
- Excessive use of alcohol defined as regular consumption of ≥14 units/week
- Unwilling to abstain from alcohol use for 1 week prior to start of the study through end of study follow up
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 |
|---|---|---|
| ALG-097558single or multiple doses of ALG-097558 | Drug | ALG-097558, ALG-097558 and Carbamazepine, ALG-097558 and Midazolam, ALG-097558, Placebo, and, Itraconazole |
| Placebosingle or multiple doses of placebo | Drug | ALG-097558, Placebo, and, Itraconazole, Placebo |
| MidazolamMultiple doses of Midazolam | Drug | ALG-097558 and Midazolam |
| ItraconazoleMultiple doses of Itraconazole | Drug | ALG-097558, Placebo, and, Itraconazole |
| CarbamazepineMultiple doses of Carbamazepine | Drug | ALG-097558 and Carbamazepine |
| ALG-097558 in solution formulationALG-097558 in solution administered in fasted state | Drug | ALG-097558 Bioavailability |
| ALG-097558 in tablet formulationALG-097558 in tablet administered in fasted and fed state | Drug | ALG-097558 Bioavailability |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 11 days for Part 1
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 20 days for Part 2
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 20 days for Part 3
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 23 days for Part 4
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 28 days for Part 5
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 17 days for Part 6
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Area under the concentration time curve [AUC]
Time frame: Predose (-2 hours) up to 11 days
Pharmacokinetic parameters of Midazolam and applicable metabolites
Time to maximum plasma concentration [Tmax]
Time frame: Predose (-2 hours) up to 11 days
Pharmacokinetic parameters of Midazolam and applicable metabolites
Maximum plasma concentration [Cmax]
Time frame: Predose (-2 hours) up to 11 days
Pharmacokinetic parameters of Midazolam and applicable metabolites
Minimum plasma concentration [Cmin]
Time frame: Predose (-2 hours) up to 11 days
Pharmacokinetic parameters of Midazolam and applicable metabolites
C0 [predose]
Time frame: Predose (-2 hours) up to 11 days
Pharmacokinetic parameters of Midazolam and applicable metabolites
Half-life [t1/2]
Time frame: Predose (-2 hours) up to 11 days
Pharmacokinetic parameters of Midazolam and applicable metabolites
Area under the concentration time curve [AUC]
Time frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Time to maximum plasma concentration [Tmax]
Time frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Maximum plasma concentration [Cmax]
Time frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Minimum plasma concentration [Cmin]
Time frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
C0 [predose]
Time frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Half-life [t1/2]
Time frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Area under the concentration time curve [AUC]
Time frame: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Time to maximum plasma concentration [Tmax]
Time frame: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Maximum plasma concentration [Cmax]
Time frame: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Minimum plasma concentration [Cmin]
Time frame: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
C0 [predose]
Time frame: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Half-life [t1/2]
Time frame: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
7 secondary outcomes
Maximum plasma concentration [Cmax]
Time frame: Predose (-0.75 hours) up to 19 days
Area under the concentration time curve [AUC]
Time frame: Predose (-0.75 hours) up to 19 days
Time to maximum plasma concentration [Tmax]
Time frame: Predose (-0.75 hours) up to 19 days
Minimum plasma concentration [Cmin]
Time frame: Predose (-0.75 hours) up to 19 days
Half-life [t1/2]
Time frame: Predose (-0.75 hours) up to 19 days
C0 [predose]
Time frame: Predose (-0.75 hours) up to 19 days
Dose Proportionality
Time frame: Predose (-0.75 hours) up to 19 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 8 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 ALG-097558, Midazolam and Itraconazole in people with COVID-19, run by Aligos Therapeutics at 1 site in United Kingdom.
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 4 inclusion and 7 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 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Up to 11 days for Part 1). The study lists 24 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 8 Apr 2025.