Healthy Adult ParticipantsPhase 1NCT07791303

Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects

A Phase 1 study testing Ketamir-2 in people with Healthy Adult Participants, run by MIRA Pharmaceuticals at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of oral Ketamir-2 in healthy adult participants. The study includes single ascending dose cohorts and multiple ascending dose cohorts. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Adult Participants
What is being tested?: Ketamir-2
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 1 siteIsrael
Study dates: 20 Mar 2025to 5 Mar 2026
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and female participants, ages 18-65.
Understands the study procedures described in the Informed Consent Form, be willing and able to comply with the protocol, and provides written consent.
Not pregnant or lactating and willing to comply with the contraceptive requirements from enrollment to 3 months post last dose.
In good health with no history of clinically significant medical conditions or suicide liability that would interfere with participant safety, as defined by medical history, physical examination and routine laboratory tests, ECG and determined by the Investigator at an admission evaluation.
Participants will have a documented medical history either prior to entering the study and/or following medical history review with the study physician at screening.

Who cannot join

History or evidence of any clinically significant or currently active cardiovascular, (including thromboembolic events), respiratory, dermatological, gastrointestinal, endocrine, hematological, hepatic, immunological, rheumatological, metabolic, urological, renal, neurological, psychiatric illness.
History of anaphylaxis and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the principal investigator (PI).
History or presence of alcohol addiction, or excessive use of alcohol, or use of drugs of abuse.
Psychiatric illness including participants with a history of depression and/or anxiety with associated severe psychiatric comorbidities, for example psychosis.
Participants who are currently smoking or former regular cigarette smokers.
Body Mass Index (BMI) ≤18 Kg/m2 and ≥28 Kg/m2.

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Venous access is deemed inadequate for the phlebotomy and cannulation demands of the study.
At the discretion of the PI, any clinically significant abnormal finding on screening biochemistry, hematology, serology microbiology blood tests or urinalysis or positive HIV, active/chronic hepatitis B or C test.
Twelve-lead ECG recording with clinically relevant abnormalities as judged by the study physician/PI.
Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to screening.
Use of any medication or product (prescription or over the counter), including therapeutics for central nervous system activity (such as Ritalin, and its derivatives, antidepressants, hypnotics, anti-psychotics, or similar) within 14 days or 5 half-lives (whatever is longer) prior to screening until completion of the study.
Receipt of any investigational drug within 3 months prior to screening or receipt of three or more investigational drugs within the previous 12 months prior to screening.
Over the counter medications (e.g., paracetamol or ibuprofen) where the dose taken over the preceding 14 days prior to the planned date of drug administration had exceeded the maximum permissible 24-hour dose.
Participants who have received any systemic chemotherapy agent, immunoglobulins, or other cytotoxic or immunosuppressive drugs at any time.

Trial locations and contacts

1 site in 1 country.

Israel1 site

Hadassah Clinical Research Unit
Jerusalem

Other trials in Israel

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Centre Study of Single and Repeated Dosing of Ascending Doses, to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects

Conditions: Healthy Adult Participants
Being tested: Ketamir-2, Placebo
Keywords: Ketamir-2, Ketamir hemipamoate, healthy participants, Phase 1, Single ascending dose, Multiple Ascending dose, Safety, Tolerability, neuropathic, neuropathic pain
Medical subject headings: Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ketamir-2Drug
Ketamir-2, also referred to as Ketamir hemipamoate, was administered orally as capsules containing 50 mg or 300 mg. Participants randomized to active treatment received Ketamir-2 according to assigned dose cohort. Cohorts 1 through 4 received a single dose on Day 1. Cohorts 5 through 7 received once-daily dosing from Day 1 through Day 5. Capsules were swallowed together with a glass of water after an overnight fast.
PlaceboDrug
Placebo capsules were identical in appearance to active capsules and were administered orally according to the same number of capsules and dosing schedule as the corresponding Ketamir-2 dose cohort.

Study groups in NCT07791303
Study group	Role	What they receive
Cohort 1: Single Dose Ketamir-2 50 mg or Placebo	Experimental	Participants in Cohort 1 were randomized in a 3:1 ratio to receive a single oral dose of Ketamir-2 50 mg or matching placebo on Day 1. Ketamir-2 was administered as one 50 mg capsule. Matching placebo was administered as one capsule. Receives: Drug: Ketamir-2; Drug: Placebo
Cohort 2: Single Dose Ketamir-2 150 mg or Placebo	Experimental	Participants in Cohort 2 were randomized in a 3:1 ratio to receive a single oral dose of Ketamir-2 150 mg or matching placebo on Day 1. Ketamir-2 was administered as three 50 mg capsules. Matching placebo was administered as three capsules. Receives: Drug: Ketamir-2; Drug: Placebo
Cohort 3: Single Dose Ketamir-2 300 mg or Placebo	Experimental	Participants in Cohort 3 were randomized in a 3:1 ratio to receive a single oral dose of Ketamir-2 300 mg or matching placebo on Day 1. Ketamir-2 was administered as one 300 mg capsule. Matching placebo was administered as one capsule. Receives: Drug: Ketamir-2; Drug: Placebo
Cohort 4: Single Dose Ketamir-2 600 mg or Placebo	Experimental	Participants in Cohort 4 were randomized in a 3:1 ratio to receive a single oral dose of Ketamir-2 600 mg or matching placebo on Day 1. Ketamir-2 was administered as two 300 mg capsules. Matching placebo was administered as two capsules. Receives: Drug: Ketamir-2; Drug: Placebo
Cohort 5: Ketamir-2 150 mg Once Daily for 5 Days or Placebo	Experimental	Participants in Cohort 5 were randomized in a 3:1 ratio to receive Ketamir-2 150 mg or matching placebo once daily for 5 days, from Day 1 through Day 5. Ketamir-2 was administered as three 50 mg capsules once daily. Matching placebo was administered as three capsules once daily. Receives: Drug: Ketamir-2; Drug: Placebo
Cohort 6: Ketamir-2 300 mg Once Daily for 5 Days or Placebo	Experimental	Participants in Cohort 6 were randomized in a 3:1 ratio to receive Ketamir-2 300 mg or matching placebo once daily for 5 days, from Day 1 through Day 5. Ketamir-2 was administered as one 300 mg capsule once daily. Matching placebo was administered as one capsule once daily. Receives: Drug: Ketamir-2; Drug: Placebo
Cohort 7: Ketamir-2 600 mg Once Daily for 5 Days or Placebo	Experimental	Participants in Cohort 7 were randomized in a 3:1 ratio to receive Ketamir-2 600 mg or matching placebo once daily for 5 days, from Day 1 through Day 5. Ketamir-2 was administered as two 300 mg capsules once daily. Matching placebo was administered as two capsules once daily. Receives: Drug: Ketamir-2; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Incidence of adverse events
Measured: From first dose through dosing period until 7 days post last dose
Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
Clinical laboratory assessments include urinalysis and blood tests. Clinically significant laboratory abnormality is determined by the investigator.
Measured: From baseline through end of study visit
Number of Participants With Clinically Significant Vital Sign Abnormalities
Vital sign assessments include blood pressure, heart rate, respiratory rate, and oral temperature. Clinically significant vital sign abnormality is determined by the investigator.
Measured: From baseline through end of study visit
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities on a 12-Lead ECG
Safety ECG will be assessed using 12-lead ECG recordings. Clinically significant abnormality is determined by the investigator.
Measured: From baseline through end of study visit
Number of Participants With Clinically Significant Physical Examination Findings
A focused physical examination will be performed prior to dosing on Day 1 and upon discharge on Day 2. For cohorts 5-7, a focused physical examination will be performed prior to dosing on Day 1, on Day 3, and Day 6. Examination of the cardiovascular system is mandatory, while the other body systems will be examined at the discretion of the Principal Investigator.
Measured: From baseline through end of study visit
Number of Participants With Ketamine-Related Side Effects as Assessed by the Ketamine Side Effect Tool (KSET)
The Ketamine Side Effect Tool will be used to assess ketamine-related side effects.
Measured: From baseline through end of study visit
Change From Baseline in Bowdle Visual Analog Scale (VAS) Score
The Bowdle VAS is a tool used to measure the psychedelic effects of substances. It consists of 13 items (each scored on 0-100 mm) that assess both internal perception and external perception. Higher scores indicate greater subjective effects.
Measured: From baseline through end of study visit

Secondary outcomes (4)

Peak Plasma Concentration (Cmax) of Ketamir-2
Measured: Single Ascending Dose cohorts: Day 1 through Day 2; Multiple Ascending Dose cohorts: Day 1 through Day 6
Area Under the Plasma Concentration Versus Time Curve (AUC)
Measured: Single Ascending Dose cohorts: Day 1 through Day 2; Multiple Ascending Dose cohorts: Day 1 through Day 6
Time to Reach Maximum Plasma Concentration (Tmax)
Measured: Single Ascending Dose cohorts: Day 1 through Day 2; Multiple Ascending Dose cohorts: Day 1 through Day 6
Percent of Dose Recovered in Urine Over each Collection Period
Urine samples will be obtained prior to first dosing, every 3 hours up to 12 hours post-dose, and 12-24 hours post-dose.
Measured: Single Ascending Dose cohorts: Day 1 through Day 2; Multiple Ascending Dose cohorts: Day 1 through Day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 20255 Mar 2026

First posted27 Aug 2026
Study start20 Mar 2025
Primary completion5 Mar 2026
Study completion5 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Adult ParticipantsStudies 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: Not applicable
Intervention model: Sequential
Model description: Participants were enrolled sequentially into 7 ascending-dose cohorts. Cohorts 1 through 4 comprised the single ascending dose portion of the study, and Cohorts 5 through 7 comprised the multiple ascending dose portion. Within each cohort, participants were randomized in a 3:1 ratio to receive Ketamir-2 or matching placebo, respectively. Sentinel dosing was used in each cohort, with one participant receiving active treatment and one participant receiving placebo before dosing the remaining participants in the cohort. Dose escalation occurred after review of safety and tolerability data of the prior cohort by the Safety Steering Committee. The transition from Cohort 4 to Cohort 5 was reviewed and confirmed by an independent Data Safety Monitoring Committee, which also reviewed pharmacokinetic data from Cohorts 1 through 4.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07791303
Sponsor's protocol ID: Mira-001
Status last verified: Aug 2026
First submitted: 19 Aug 2026
Last updated: 27 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Centre Study of Single and Repeated Dosing of Ascending Doses, to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT07791303
Acronym / sponsor ID: Mira-001
Conditions: Healthy Adult Participants
Keywords: Ketamir-2, Ketamir hemipamoate, healthy participants, Phase 1, Single ascending dose, Multiple Ascending dose, Safety, Tolerability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: MIRA PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 20 Mar 2025 (actual)
Primary completion: 5 Mar 2026 (actual)
Study completion: 5 Mar 2026 (actual)
First posted: 27 Aug 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7
Model description: Participants were enrolled sequentially into 7 ascending-dose cohorts. Cohorts 1 through 4 comprised the single ascending dose portion of the study, and Cohorts 5 through 7 comprised the multiple ascending dose portion. Within each cohort, participants were randomized in a 3:1 ratio to receive Ketamir-2 or matching placebo, respectively. Sentinel dosing was used in each cohort, with one participant receiving active treatment and one participant receiving placebo before dosing the remaining participants in the cohort. Dose escalation occurred after review of safety and tolerability data of the prior cohort by the Safety Steering Committee. The transition from Cohort 4 to Cohort 5 was reviewed and confirmed by an independent Data Safety Monitoring Committee, which also reviewed pharmacokinetic data from Cohorts 1 through 4.

Arm	Type	Receives
Cohort 1: Single Dose Ketamir-2 50 mg or Placebo	Experimental	Drug: Ketamir-2, Drug: PlaceboParticipants in Cohort 1 were randomized in a 3:1 ratio to receive a single oral dose of Ketamir-2 50 mg or matching placebo on Day 1. Ketamir-2 was administered as one 50 mg capsule. Matching placebo was administered as one capsule.
Cohort 2: Single Dose Ketamir-2 150 mg or Placebo	Experimental	Drug: Ketamir-2, Drug: PlaceboParticipants in Cohort 2 were randomized in a 3:1 ratio to receive a single oral dose of Ketamir-2 150 mg or matching placebo on Day 1. Ketamir-2 was administered as three 50 mg capsules. Matching placebo was administered as three capsules.
Cohort 3: Single Dose Ketamir-2 300 mg or Placebo	Experimental	Drug: Ketamir-2, Drug: PlaceboParticipants in Cohort 3 were randomized in a 3:1 ratio to receive a single oral dose of Ketamir-2 300 mg or matching placebo on Day 1. Ketamir-2 was administered as one 300 mg capsule. Matching placebo was administered as one capsule.
Cohort 4: Single Dose Ketamir-2 600 mg or Placebo	Experimental	Drug: Ketamir-2, Drug: PlaceboParticipants in Cohort 4 were randomized in a 3:1 ratio to receive a single oral dose of Ketamir-2 600 mg or matching placebo on Day 1. Ketamir-2 was administered as two 300 mg capsules. Matching placebo was administered as two capsules.
Cohort 5: Ketamir-2 150 mg Once Daily for 5 Days or Placebo	Experimental	Drug: Ketamir-2, Drug: PlaceboParticipants in Cohort 5 were randomized in a 3:1 ratio to receive Ketamir-2 150 mg or matching placebo once daily for 5 days, from Day 1 through Day 5. Ketamir-2 was administered as three 50 mg capsules once daily. Matching placebo was administered as three capsules once daily.
Cohort 6: Ketamir-2 300 mg Once Daily for 5 Days or Placebo	Experimental	Drug: Ketamir-2, Drug: PlaceboParticipants in Cohort 6 were randomized in a 3:1 ratio to receive Ketamir-2 300 mg or matching placebo once daily for 5 days, from Day 1 through Day 5. Ketamir-2 was administered as one 300 mg capsule once daily. Matching placebo was administered as one capsule once daily.
Cohort 7: Ketamir-2 600 mg Once Daily for 5 Days or Placebo	Experimental	Drug: Ketamir-2, Drug: PlaceboParticipants in Cohort 7 were randomized in a 3:1 ratio to receive Ketamir-2 600 mg or matching placebo once daily for 5 days, from Day 1 through Day 5. Ketamir-2 was administered as two 300 mg capsules once daily. Matching placebo was administered as two capsules once daily.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male and female participants, ages 18-65.
Understands the study procedures described in the Informed Consent Form, be willing and able to comply with the protocol, and provides written consent.
Not pregnant or lactating and willing to comply with the contraceptive requirements from enrollment to 3 months post last dose.
In good health with no history of clinically significant medical conditions or suicide liability that would interfere with participant safety, as defined by medical history, physical examination and routine laboratory tests, ECG and determined by the Investigator at an admission evaluation.
Participants will have a documented medical history either prior to entering the study and/or following medical history review with the study physician at screening.

Key exclusion criteria (14 listed)

History or evidence of any clinically significant or currently active cardiovascular, (including thromboembolic events), respiratory, dermatological, gastrointestinal, endocrine, hematological, hepatic, immunological, rheumatological, metabolic, urological, renal, neurological, psychiatric illness.
History of anaphylaxis and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the principal investigator (PI).
History or presence of alcohol addiction, or excessive use of alcohol, or use of drugs of abuse.
Psychiatric illness including participants with a history of depression and/or anxiety with associated severe psychiatric comorbidities, for example psychosis.
Participants who are currently smoking or former regular cigarette smokers.

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
Ketamir-2Ketamir-2, also referred to as Ketamir hemipamoate, was administered orally as capsules containing 50 mg or 300 mg. Participants randomized to active treatment received Ketamir-2 according to assigned dose cohort. Cohorts 1 through 4 received a single dose on Day 1. Cohorts 5 through 7 received once-daily dosing from Day 1 through Day 5. Capsules were swallowed together with a glass of water after an overnight fast.	Drug	Cohort 1: Single Dose Ketamir-2 50 mg or Placebo, Cohort 2: Single Dose Ketamir-2 150 mg or Placebo, Cohort 3: Single Dose Ketamir-2 300 mg or Placebo, Cohort 4: Single Dose Ketamir-2 600 mg or Placebo, Cohort 5: Ketamir-2 150 mg Once Daily for 5 Days or Placebo, Cohort 6: Ketamir-2 300 mg Once Daily for 5 Days or Placebo, Cohort 7: Ketamir-2 600 mg Once Daily for 5 Days or Placebo
PlaceboPlacebo capsules were identical in appearance to active capsules and were administered orally according to the same number of capsules and dosing schedule as the corresponding Ketamir-2 dose cohort.	Drug	Cohort 1: Single Dose Ketamir-2 50 mg or Placebo, Cohort 2: Single Dose Ketamir-2 150 mg or Placebo, Cohort 3: Single Dose Ketamir-2 300 mg or Placebo, Cohort 4: Single Dose Ketamir-2 600 mg or Placebo, Cohort 5: Ketamir-2 150 mg Once Daily for 5 Days or Placebo, Cohort 6: Ketamir-2 300 mg Once Daily for 5 Days or Placebo, Cohort 7: Ketamir-2 600 mg Once Daily for 5 Days or Placebo

Primary outcome

Number of Participants with Incidence of adverse events
Time frame: From first dose through dosing period until 7 days post last dose
Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
Time frame: From baseline through end of study visit
Clinical laboratory assessments include urinalysis and blood tests. Clinically significant laboratory abnormality is determined by the investigator.
Number of Participants With Clinically Significant Vital Sign Abnormalities
Time frame: From baseline through end of study visit
Vital sign assessments include blood pressure, heart rate, respiratory rate, and oral temperature. Clinically significant vital sign abnormality is determined by the investigator.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities on a 12-Lead ECG
Time frame: From baseline through end of study visit
Safety ECG will be assessed using 12-lead ECG recordings. Clinically significant abnormality is determined by the investigator.
Number of Participants With Clinically Significant Physical Examination Findings
Time frame: From baseline through end of study visit
A focused physical examination will be performed prior to dosing on Day 1 and upon discharge on Day 2. For cohorts 5-7, a focused physical examination will be performed prior to dosing on Day 1, on Day 3, and Day 6. Examination of the cardiovascular system is mandatory, while the other body systems will be examined at the discretion of the Principal Investigator.
Number of Participants With Ketamine-Related Side Effects as Assessed by the Ketamine Side Effect Tool (KSET)
Time frame: From baseline through end of study visit
The Ketamine Side Effect Tool will be used to assess ketamine-related side effects.
Change From Baseline in Bowdle Visual Analog Scale (VAS) Score
Time frame: From baseline through end of study visit
The Bowdle VAS is a tool used to measure the psychedelic effects of substances. It consists of 13 items (each scored on 0-100 mm) that assess both internal perception and external perception. Higher scores indicate greater subjective effects.

4 secondary outcomes

Peak Plasma Concentration (Cmax) of Ketamir-2
Time frame: Single Ascending Dose cohorts: Day 1 through Day 2; Multiple Ascending Dose cohorts: Day 1 through Day 6
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: Single Ascending Dose cohorts: Day 1 through Day 2; Multiple Ascending Dose cohorts: Day 1 through Day 6
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: Single Ascending Dose cohorts: Day 1 through Day 2; Multiple Ascending Dose cohorts: Day 1 through Day 6
Percent of Dose Recovered in Urine Over each Collection Period
Time frame: Single Ascending Dose cohorts: Day 1 through Day 2; Multiple Ascending Dose cohorts: Day 1 through Day 6

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 27 Aug 2026.

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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 Ketamir-2 in people with Healthy Adult Participants, run by MIRA Pharmaceuticals at 1 site in Israel.

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 14 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 27 Aug 2026. 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 Israel. 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 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 with Incidence of adverse events (time frame: From first dose through dosing period until 7 days post last dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07791303.

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 27 Aug 2026.