HealthyPhase 1NCT07016464
A Study to Investigate Safety, Tolerability and Pharmacokinetics of REM0045392 Compared With Placebo in Healthy Participants.
A Phase 1 study testing REM0045392 in people with Healthy, run by reMYND at 1 site in Belgium.
Trial summary
This study is testing if the medicine REM0045392 is safe and well-tolerated. It also looks at whether food affects how the medicine works. The medicine will be tested in Healthy men (Part 1 and 2) and Healthy Older men and women (Part 3). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- REM0045392
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Mar 2025to 23 Jun 2025
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male participants between 18 and 55 years of age, inclusive, at screening. For Part 3: male and females participants, aged between 65 and 85 years of age, inclusive, at screening
- Otherwise healthy with no clinically significant abnormalities as determined by medical history, coagulation, blood chemistry assessments, hematologic assessments, and urinalysis at screening; and physical examination, measurement of vital signs and ECG at screening and Day 1 predose (of the first treatment period, if applicable).
- Note: Isolated out-of-range values judged by the investigator (or designated physician) to be of no clinical significance can be allowed. This determination must be recorded in the electronic source (eSource) system.
- For Part 3: elderly participants should be healthy for age. Mild and controlled comorbidities can be allowed at the discretion of the Investigator - as long as they do not interfere with the objectives of the study
- Have a body weight in the range of 50 to 100 kg, inclusive, at screening. Have a body mass index (BMI) of 19.0 to 30.0 kg/m2, inclusive, at screening.
- For Part 3: have a BMI of 19.0 to 32.0 kg/m2, inclusive, at screening
Show all 14Show fewer
- Agree to abstain from alcohol intake 24 hours before administration of investigational product, during the in-patient period of the study, and 24 hours prior to all other out patient clinic visits.
- Agree not to use prescription medications within 14 days prior to first investigational product administration and through the end of the study, unless approved by the investigator.
- For Part 3: elderly participants can be allowed to take their chronic medication (> 3 months stable dose) if this medication does not interfere with the absorption, distribution and elimination of the study drug.
- Agree not to use over-the-counter medications (including corticosteroids, Aspirin, decongestants, antihistamines, and other non-steroidal anti-inflammatory drugs [NSAIDs]), and herbal medication (including herbal tea, St. John's Wort), within 14 days prior to the first investigational product administration through the end of the study, unless approved by the investigator.
- Have signed the Informed Consent Form (ICF) voluntarily before any study related procedure is performed, indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study.
- Male participants who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 90 days after the last administration of investigational product. Sperm donation is also not allowed from the first administration until 90 days after the last administration of investigational product.
- Note: Medically acceptable method of contraception that may be used by the participant includes vasectomy for male participants and for non-vasectomized male participants having a female partner of childbearing potential acceptable options includes using a condom in combination with one of the following: combined oral contraceptive, contraceptive injection, intrauterine device, levonorgestrel implant, or being surgically sterile. For male participants having a female pregnant partner, a condom must be used.
- For Part 3: female participants should be postmenopausal as defined as spontaneous amenorrhea for more then 12 consecutive months; or spontaneous amenorrhea for less then 6 months with biochemical criteria of menopause (follicle-stimulating hormone >40 IU/L) or surgically sterile.
Who cannot join
- Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to) cardiovascular disease, neuromuscular disease, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, diseases affecting bone mineral density, endocrine disease, or dermatological disease.
- Have a clinically significant or chronic infection or diagnosed latent infection.
- Significant acute illness within 7 days prior to the first investigational product administration or have had a major illness or hospitalization within 1 month prior to the first investigational product administration.
- For CSF collection:
- Lower back surgery in the past interfering with lumbar puncture
- History of severe Post Dural Puncture Headache requiring blood patch (PDPH)
Show all 34Show fewer
- History or indications of elevated intracranial pressure as observed (fundoscopy)
- Any of the following findings on resting ECG:
- QT interval corrected for heart rate (HR) using Fridericia's formula (QTcF) > 450 ms (males) or < 300 ms at screening or baseline visit (Day 1 pre dose).
- Notable resting bradycardia (HR < 40 bpm) or tachycardia (HR > 100 bpm) at screening or baseline visit (Day 1 pre-dose).
- Family history of congenital long QT syndrome or sudden death.
- Screening or baseline (Day 1 pre-dose) ECG with QRS and/or T wave judged to be unfavorable for a consistently accurate QT measurement (e.g., neuromuscular artifact that cannot be readily eliminated, arrhythmia, indistinct QRS onset, low amplitude T wave, merged T and U waves, prominent U waves).
- Evidence of atrial fibrillation, atrial flutter, complete left or right bundle branch block (LBBB/RBBB), incomplete LBBB, incomplete RBBB, Wolf Parkinson White syndrome, or cardiac pacemaker at screening or baseline visit (Day 1 pre-dose) (note: a first-degree heart block with PR not exceeding 250 ms can be allowed).
- For Part 3: in elderly participants:
- QTcF > 450 ms (males); > 470 ms (females) or < 300 ms at screening or baseline visit (Day 1 pre dose).
- Notable resting bradycardia (HR < 45 bpm) or tachycardia (HR > 100 bpm) at screening or baseline visit (Day 1 pre-dose).
- Family history of congenital long QT syndrome or sudden death.
- Wolff Parkinson White syndrome, complete LBBB (note: a first-degree heart block with PR not exceeding 250 ms, treated atrial fibrillation /flutter and incomplete LBBB can be allowed).
- Have an estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) method of < 80 mL/min/1.73 m².
- For Part 3: elderly participants have an eGFR (CKD-EPI) <60 mL/min/1.73 m². In case of an abnormal result, recheck is authorized if needed and this recheck can consist of a 24h urine collection to measure real creatinine clearance when deemed necessary.
- Systolic blood pressure (SBP) greater than 140 or less than 90 mmHg, and diastolic blood pressure (DBP) greater than 90 or less than 45 mm Hg For Part 3: in elderly participants: SBP greater than 160 or less than 90 mmHg, and DBP greater than 95 or less than 45 mm Hg
- Major or traumatic surgery within 12 weeks of screening.
- Any participant who plans to undergo elective surgery within 4 weeks prior to the first investigational product administration and through the end of the study.
- Positive serology test for human immunodeficiency virus (HIV) type 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies at screening.
- Recent history (within the previous 6 months from screening) of alcohol or drug abuse.
- Active smoker and/or has used nicotine or nicotine-containing products (including e-cigarettes or the equivalent of e-cigarettes) within the past 6 months before the first investigational product administration.
- Have positive urine toxicology screen at screening or Day -1 for substances of abuse including amphetamines, benzodiazepine, cocaine, opiates, methadone, cannabinoids, and tricyclic antidepressants.
- Note: Participants should not consume poppy seeds within 24 hours before screening and before each urine drug screening because this can falsify the results of the opiate urine drug test.
- Have a positive alcohol breath test at screening or Day -1.
- Consumes, on average, more than approximately 500 mg/day of caffeine (as contained in 5 cups of tea or coffee or 8 cans of soda or other caffeinated products per day) at screening.
- Donated blood within 90 days prior to first investigational administration.
- Have a history of active drug and/or food allergy or other active allergic disease requiring the constant use of medications, or a history of severe allergic reaction, angioedema or anaphylaxis at screening.
- Received any other experimental therapy or new investigational agent within 30 days or 5 half-lives (whichever is longer) of the first investigational product administration.
- Treatment with any medication (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks), in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing of investigational product For Part 3: elderly participants taking the following prohibited medications/substances: Strong Cytochrome (CYP) 3A4-1A2-2D6 inhibitors (Wash out prior to Baseline 30 days or 5 half-lives, whichever is longer), and sensitive CYP2B6 -2D6 substrates (assessed on a case-by-case basis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of REM0045392 to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Food Effect in Healthy Male Participants and in a Panel of Healthy Elderly Participants (Both Sexes)
This study is testing if the medicine REM0045392 is safe and well-tolerated. It also looks at whether food affects how the medicine works.
The medicine will be tested in Healthy men (Part 1 and 2) and Healthy Older men and women (Part 3).
Participants will take the medicine once (in Part 1) or during 14 days (in Part 2 and 3), with increasing doses.
REM0045392 is being developed as a treatment for Alzheimer's disease.
- Conditions
- Healthy
- Being tested
- REM0045392, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REM0045392Drug
Liquid formulation
PlaceboDrug
Liquid formulation
| Study group | Role | What they receive |
|---|---|---|
| Part 1 SAD - Panel A Treatment Period 1 | Experimental | Not described Receives: Drug: REM0045392; Drug: Placebo |
| Part 1 SAD - Panel B Treatment Period 1 | Experimental | Not described Receives: Drug: REM0045392; Drug: Placebo |
| Part 1 SAD - Panel A Treatment Period 2 | Experimental | Not described Receives: Drug: REM0045392; Drug: Placebo |
| Part 1 SAD - Panel B Treatment Period 2 | Experimental | Not described Receives: Drug: REM0045392; Drug: Placebo |
| Part 1 SAD - Panel A Treatment Period 3 | Experimental | Not described Receives: Drug: REM0045392; Drug: Placebo |
| Part 1 SAD - Panel B Treatment Period 3 | Experimental | Not described Receives: Drug: REM0045392; Drug: Placebo |
| Part 1 SAD - Panel A Treatment Period 4 | Experimental | Not described Receives: Drug: REM0045392; Drug: Placebo |
| Part 1 SAD - Panel B Treatment Period 4 | Experimental | Not described Receives: Drug: REM0045392; Drug: Placebo |
| Part 2 MAD - Panel C | Experimental | Not described Receives: Drug: REM0045392; Drug: Placebo |
| Part 2 MAD - Panel D | Experimental | Not described Receives: Drug: REM0045392; Drug: Placebo |
| Part 2 MAD - Panel E | Experimental | Not described Receives: Drug: REM0045392; Drug: Placebo |
| Part 3 Elderly - Panel G | Experimental | Not described Receives: Drug: REM0045392; Drug: Placebo |
| Part 2 MAD - Panel F (optional) | Experimental | Not described Receives: Drug: REM0045392; Drug: Placebo |
| Part 3 Elderly - Panel H (optional) | Experimental | Not described Receives: Drug: REM0045392; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Related Adverse Events
To assess the safety and tolerability of REM0045392
Measured: Throughout the study, until 7-10 days post last dose
Secondary outcomes (10)
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Area under curve (AUC) in plasma
Measured: Up to 48 hours after last intervention
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Maximum concentration (Cmax) in plasma
Measured: Up to 48 hours after last intervention
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Time to peak drug concentration (Tmax) in plasma
Measured: Up to 48 hours after last intervention
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Half-life in plasma
Measured: Up to 48 hours after last intervention
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Clearance (CL/F) in plasma
Measured: Up to 48 hours after last intervention
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Volume of distribution (V/F) in plasma
Measured: Up to 48 hours after last intervention
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Peak to trough fluctuation ratio in plasma
Measured: Up to 48 hours after last intervention
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Accumulation index in plasma
Measured: Up to 48 hours after last intervention
Concentrations of REM0045392 measured in CSF samples
Measured: Up to 24h after study intervention
Assessment of the effect of REM0045392 on the QT interval on ECG
QTc changes in function of observed plasma concentrations of REM0045932
Measured: Up to 48h after last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start20 Mar 2025
- Primary completion23 Jun 2025
- Study completion23 Jun 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- reMYND
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016464
- Sponsor's protocol ID
- REMAD-04
- Status last verified
- Nov 2025
- First submitted
- 23 May 2025
- Last updated
- 4 Feb 2026
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of REM0045392 to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Food Effect in Healthy Male Participants and in a Panel of Healthy Elderly Participants (Both Sexes)
- ClinicalTrials.gov ID
- NCT07016464
- Acronym / sponsor ID
- REMAD-04
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 19 participants (actual)
- Lead sponsor
- reMYNDIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 11 Jun 2025 (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 is testing if the medicine REM0045392 is safe and well-tolerated. It also looks at whether food affects how the medicine works.
The medicine will be tested in Healthy men (Part 1 and 2) and Healthy Older men and women (Part 3).
Participants will take the medicine once (in Part 1) or during 14 days (in Part 2 and 3), with increasing doses.
REM0045392 is being developed as a treatment for Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part 1 SAD - Panel A Treatment Period 1 | Experimental | Drug: REM0045392, Drug: Placebo |
| Part 1 SAD - Panel B Treatment Period 1 | Experimental | Drug: REM0045392, Drug: Placebo |
| Part 1 SAD - Panel A Treatment Period 2 | Experimental | Drug: REM0045392, Drug: Placebo |
| Part 1 SAD - Panel B Treatment Period 2 | Experimental | Drug: REM0045392, Drug: Placebo |
| Part 1 SAD - Panel A Treatment Period 3 | Experimental | Drug: REM0045392, Drug: Placebo |
| Part 1 SAD - Panel B Treatment Period 3 | Experimental | Drug: REM0045392, Drug: Placebo |
| Part 1 SAD - Panel A Treatment Period 4 | Experimental | Drug: REM0045392, Drug: Placebo |
| Part 1 SAD - Panel B Treatment Period 4 | Experimental | Drug: REM0045392, Drug: Placebo |
| Part 2 MAD - Panel C | Experimental | Drug: REM0045392, Drug: Placebo |
| Part 2 MAD - Panel D | Experimental | Drug: REM0045392, Drug: Placebo |
| Part 2 MAD - Panel E | Experimental | Drug: REM0045392, Drug: Placebo |
| Part 3 Elderly - Panel G | Experimental | Drug: REM0045392, Drug: Placebo |
| Part 2 MAD - Panel F (optional) | Experimental | Drug: REM0045392, Drug: Placebo |
| Part 3 Elderly - Panel H (optional) | Experimental | Drug: REM0045392, Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male participants between 18 and 55 years of age, inclusive, at screening. For Part 3: male and females participants, aged between 65 and 85 years of age, inclusive, at screening
- Otherwise healthy with no clinically significant abnormalities as determined by medical history, coagulation, blood chemistry assessments, hematologic assessments, and urinalysis at screening; and physical examination, measurement of vital signs and ECG at screening and Day 1 predose (of the first treatment period, if applicable).
- Note: Isolated out-of-range values judged by the investigator (or designated physician) to be of no clinical significance can be allowed. This determination must be recorded in the electronic source (eSource) system.
- For Part 3: elderly participants should be healthy for age. Mild and controlled comorbidities can be allowed at the discretion of the Investigator - as long as they do not interfere with the objectives of the study
- Have a body weight in the range of 50 to 100 kg, inclusive, at screening. Have a body mass index (BMI) of 19.0 to 30.0 kg/m2, inclusive, at screening.
Key exclusion criteria (34 listed)
- Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to) cardiovascular disease, neuromuscular disease, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, diseases affecting bone mineral density, endocrine disease, or dermatological disease.
- Have a clinically significant or chronic infection or diagnosed latent infection.
- Significant acute illness within 7 days prior to the first investigational product administration or have had a major illness or hospitalization within 1 month prior to the first investigational product administration.
- For CSF collection:
- Any of the following findings on resting ECG:
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 |
|---|---|---|
| REM0045392Liquid formulation | Drug | Part 1 SAD - Panel A Treatment Period 1, Part 1 SAD - Panel A Treatment Period 2, Part 1 SAD - Panel A Treatment Period 3, Part 1 SAD - Panel A Treatment Period 4, Part 1 SAD - Panel B Treatment Period 1, Part 1 SAD - Panel B Treatment Period 2, Part 1 SAD - Panel B Treatment Period 3, Part 1 SAD - Panel B Treatment Period 4, Part 2 MAD - Panel C, Part 2 MAD - Panel D, Part 2 MAD - Panel E, Part 2 MAD - Panel F (optional), Part 3 Elderly - Panel G, Part 3 Elderly - Panel H (optional) |
| PlaceboLiquid formulation | Drug | Part 1 SAD - Panel A Treatment Period 1, Part 1 SAD - Panel A Treatment Period 2, Part 1 SAD - Panel A Treatment Period 3, Part 1 SAD - Panel A Treatment Period 4, Part 1 SAD - Panel B Treatment Period 1, Part 1 SAD - Panel B Treatment Period 2, Part 1 SAD - Panel B Treatment Period 3, Part 1 SAD - Panel B Treatment Period 4, Part 2 MAD - Panel C, Part 2 MAD - Panel D, Part 2 MAD - Panel E, Part 2 MAD - Panel F (optional), Part 3 Elderly - Panel G, Part 3 Elderly - Panel H (optional) |
Primary outcome
Number of Participants with Treatment Related Adverse Events
Time frame: Throughout the study, until 7-10 days post last dose
To assess the safety and tolerability of REM0045392
10 secondary outcomes
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Time frame: Up to 48 hours after last intervention
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Time frame: Up to 48 hours after last intervention
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Time frame: Up to 48 hours after last intervention
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Time frame: Up to 48 hours after last intervention
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Time frame: Up to 48 hours after last intervention
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Time frame: Up to 48 hours after last intervention
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Time frame: Up to 48 hours after last intervention
Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration
Time frame: Up to 48 hours after last intervention
Concentrations of REM0045392 measured in CSF samples
Time frame: Up to 24h after study intervention
Assessment of the effect of REM0045392 on the QT interval on ECG
Time frame: Up to 48h after last intervention
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 REM0045392 in people with Healthy, run by reMYND at 1 site in Belgium.
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 14 inclusion and 34 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: stopped early, as of the sponsor's last update on 4 Feb 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 Belgium. 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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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 Treatment Related Adverse Events (time frame: Throughout the study, until 7-10 days post last dose). 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 4 Feb 2026.