MalariaPhase 1APPNCT07470424
A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults
A Phase 1 study testing Piperaquine, Artesunate-pyronaridine (Pyramax) and Piperaquine and artesunate-pyronaridine (Pyramax) in people with Malaria, run by University of Oxford at 1 site in Thailand.
Trial summary
This is an open-label pharmacokinetic study in 24 healthy Thai participants. Participants will be admitted in the inpatient ward and each participant will attend a total of 4 visits, including one screening visit and three hospital admissions. Participants will be randomized into one of six groups. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Piperaquine, Artesunate-pyronaridine (Pyramax) and Piperaquine and artesunate-pyronaridine (Pyramax)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
- Male or female non-smoker aged between 18 years to 60 years, weighting between 45 and 85 kg.
- A female is eligible to participate in this study if she is:
- of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy
- or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels >40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
- or of childbearing potential, has a negative serum pregnancy test at screening and prior to start the study drug in each period, and agrees to abstain from sexual intercourse or use effective contraceptive methods (e.g., intrauterine device, hormonal contraceptive drug, tubal ligation or female barrier method with spermicide) during the study until completion of the follow-up procedures
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- Normal electrocardiogram (ECG) with QTc <450 msec.
- Willingness and ability to comply with the study protocol for the duration of the trial.
- Participants is willing and able to give written informed consent for participation in the study
Who cannot join
- Females who are pregnant, trying to get pregnant, or are lactating.
- The participant has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.
- A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
- Participants with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes (heart failure, hypokalemia) or with a family history of long QT syndrome, Brugada syndrome, or sudden cardiac death.
- Abnormal serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) <70 mL/min as determined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- History of alcohol or substance abuse or dependence within 6 months of the study.
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- Use of prescription or non-prescription drugs except paracetamol at doses of up to 2 grams/day, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of the investigator, the medication will not interfere with the study procedures or compromise participant safety; the investigator will take advice from the manufacturer representative as necessary.
- The participant has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 times the drug half-life, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication.
- The participant is unwilling to abstain from ingesting alcohol within 48 hours prior to the first dose of study medication until collection of the final pharmacokinetic sample during each regimen.
- Participants who have donated blood to the extent that participation in the study would result in more than 300 mL blood donated within a 30-day period. Note: This does not include plasma donation.
- Participants who have a history of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation in the trial. In addition, if heparin is used during pharmacokinetic sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
- Lack of suitability for participation in this study, including but not limited to, unstable medical conditions, systemic disease manifested by tendency to granulocytopenia e.g. rheumatoid arthritis and lupus erythematosus that in the opinion of the investigator would compromise their participation in the trial.
- AST or ALT >1.5 times the upper limit of normal (ULN)
- History of antimalarial drugs use including but not limited to mefloquine, chloroquine, primaquine, artesunate, piperaquine and pyronaridine treatment within 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Medical Therapeutic Unit, Faculty of Tropical Medicine
Bangkok, Bangkok, 10400
Kittiyod Poovorawan, MD, kittiyod.poo@mahidol.ac.th
About this study
Official title: A Randomized, Open-Label Crossover Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Piperaquine, Pyronaridine and Artesunate in Healthy Adult Participants
This is an open-label pharmacokinetic study in 24 healthy Thai participants. Participants will be admitted in the inpatient ward and each participant will attend a total of 4 visits, including one screening visit and three hospital admissions. Participants will be randomized into one of six groups.
Each group will receive 3 drug regimens consisting of (1) piperaquine, (2) pyronaridine plus artesunate, or (3) piperaquine, pyronaridine, and artesunate, administered once per day for three consecutive days in different sequential orders.
Read more
After each regimen, participants will be followed up for six weeks for clinical assessments and laboratory evaluations to study the pharmacokinetics. A washout period of at least eight weeks will be implemented between each regimen.
This study is funded by the Global Health Innovative Technology Fund (GHIT Fund), Tokyo, Japan, under grant number G2025-117.
Read the detailed description
This study will enroll 24 healthy Thai participants. Participants will complete one screening visit and three inpatient study periods.
Participants will be randomly assigned to one of six study groups and will receive three different study drugs in a crossover design, as described below:
- Study drug 1: Piperaquine
- Study drug 2: Pyronaridine and artesunate
- Study drug 3: Piperaquine, pyronaridine and artesunate
Each treatment study drug will be administered for three consecutive days. The order of administration will differ by study group as follows:
Group 1 (n = 4): Study drug 1 → Study drug 2 → Study drug 3
Group 2 (n = 4): Study drug 1 → Study drug 3 → Study drug 2
Group 3 (n = 4): Study drug 2 → Study drug 1 → Study drug 3
Group 4 (n = 4): Study drug 2 → Study drug 3 → Study drug 1
Group 5 (n = 4): Study drug 3 → Study drug 1 → Study drug 2
Group 6 (n = 4): Study drug 3 → Study drug 2 → Study drug 1
After each treatment period, participants will be followed for six weeks, during which seven follow-up visits will be conducted for clinical assessments and blood sampling. A washout period of at least eight weeks will be observed between treatment periods to allow for complete elimination of the study drugs from the body.
Each participant will take part in the study for about 6 months. The entire study is expected to last about 12 months.
- Conditions
- Malaria
- Being tested
- Piperaquine, Artesunate-pyronaridine (Pyramax), Piperaquine and artesunate-pyronaridine (Pyramax)
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiperaquineDrug
Piperaquine is an antimalarial medicine normally combined with an artemisinin derivative in the combination therapy dihydroartemisinin-piperaquine.
Artesunate-pyronaridine (Pyramax)Drug
Artesunate-pyronaridine is a medicine that contains the active substances pyronaridine tetraphosphate and artesunate.
Piperaquine and artesunate-pyronaridine (Pyramax)Drug
Piperaquine is an antimalarial medicine. Artesunate-pyronaridine is a medicine that contains the active substances pyronaridine tetraphosphate and artesunate.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Piperaquine → Artesunate-pyronaridine → Piperaquine plus artesunate-pyronaridine) | Experimental | Not described Receives: Drug: Piperaquine; Drug: Artesunate-pyronaridine (Pyramax); Drug: Piperaquine and artesunate-pyronaridine (Pyramax) |
| Group 2 (Piperaquine → Piperaquine plus artesunate-pyronaridine → Artesunate-pyronaridine) | Experimental | Not described Receives: Drug: Piperaquine; Drug: Artesunate-pyronaridine (Pyramax); Drug: Piperaquine and artesunate-pyronaridine (Pyramax) |
| Group 3 (Artesunate-pyronaridine → Piperaquine → Piperaquine plus artesunate-pyronaridine) | Experimental | Not described Receives: Drug: Piperaquine; Drug: Artesunate-pyronaridine (Pyramax); Drug: Piperaquine and artesunate-pyronaridine (Pyramax) |
| Group 4 (Artesunate-pyronaridine → Piperaquine plus artesunate-pyronaridine → Piperaquine) | Experimental | Not described Receives: Drug: Piperaquine; Drug: Artesunate-pyronaridine (Pyramax); Drug: Piperaquine and artesunate-pyronaridine (Pyramax) |
| Group 5 (Piperaquine plus artesunate-pyronaridine → Piperaquine → artesunate-pyronaridine) | Experimental | Not described Receives: Drug: Piperaquine; Drug: Artesunate-pyronaridine (Pyramax); Drug: Piperaquine and artesunate-pyronaridine (Pyramax) |
| Group 6 (Piperaquine plus artesunate-pyronaridine → artesunate-pyronaridine → Piperaquine) | Experimental | Not described Receives: Drug: Piperaquine; Drug: Artesunate-pyronaridine (Pyramax); Drug: Piperaquine and artesunate-pyronaridine (Pyramax) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Adverse events will be assessed as one of safety and tolerability parameters.
Measured: Approximately 6 months
Number of events concerning of abnormal electrocardiographic
Electrocardiographic changes especially QTc interval prolongation will be assessed as one of safety and tolerability parameters.
Measured: Approximately 6 months
Number of events concerning of abnormal vital signs
Abnormal vital signs will be assessed as one of safety and tolerability parameters.
Measured: Approximately 6 months
Number of events concerning of abnormal laboratory values
Abnormal laboratory values will be assessed as one of safety and tolerability parameters.
Measured: Approximately 6 months
Secondary outcomes (6)
Area under the concentration-time curve (AUC∞)
Area under the concentration-time curve (AUC∞) of piperaquine, pyronaridine and artesunate and their metabolites when given alone and in combination.
Measured: Approximately 6 months
Area under the concentration-time curve (AUClast)
Area under the concentration-time curve (AUClast) of piperaquine, pyronaridine and artesunate and their metabolites when given alone and in combination.
Measured: Approximately 6 months
Maximum concentration (Cmax)
Maximum concentration (Cmax) of piperaquine, pyronaridine and artesunate and their metabolites when given alone and in combination.
Measured: Approximately 6 months
Elimination clearance (CL/F)
Elimination clearance (CL/F) of piperaquine, pyronaridine and artesunate and their metabolites when given alone and in combination.
Measured: Approximately 6 months
Terminal elimination half-life (t1/2)
Terminal elimination half-life (t1/2) of piperaquine, pyronaridine and artesunate and their metabolites when given alone and in combination.
Measured: Approximately 6 months
Apparent volume of distribution (Vd)
Apparent volume of distribution (Vd) of piperaquine, pyronaridine and artesunate and their metabolites when given alone and in combination.
Measured: Approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470424
- Sponsor's protocol ID
- MAL25006
- Acronym
- APP
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With participant's consent, participant's clinical data and results from blood analyses stored in our database may be shared with other researchers to use in the future in accordance with the current Data Sharing Policy. However, the other researchers will not be given any information that could identify the participant.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Crossover Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Piperaquine, Pyronaridine and Artesunate in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07470424
- Acronym / sponsor ID
- APP / MAL25006
- Conditions
- Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 13 Mar 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.
This is an open-label pharmacokinetic study in 24 healthy Thai participants. Participants will be admitted in the inpatient ward and each participant will attend a total of 4 visits, including one screening visit and three hospital admissions. Participants will be randomized into one of six groups.
Each group will receive 3 drug regimens consisting of (1) piperaquine, (2) pyronaridine plus artesunate, or (3) piperaquine, pyronaridine, and artesunate, administered once per day for three consecutive days in different sequential orders.
After each regimen, participants will be followed up for six weeks for clinical assessments and laboratory evaluations to study the pharmacokinetics. A washout period of at least eight weeks will be implemented between each regimen.
This study is funded by the Global Health Innovative Technology Fund (GHIT Fund), Tokyo, Japan, under grant number G2025-117.
Detailed description
This study will enroll 24 healthy Thai participants. Participants will complete one screening visit and three inpatient study periods.
Participants will be randomly assigned to one of six study groups and will receive three different study drugs in a crossover design, as described below:
- Study drug 1: Piperaquine
- Study drug 2: Pyronaridine and artesunate
- Study drug 3: Piperaquine, pyronaridine and artesunate
Each treatment study drug will be administered for three consecutive days. The order of administration will differ by study group as follows:
Group 1 (n = 4): Study drug 1 → Study drug 2 → Study drug 3
Group 2 (n = 4): Study drug 1 → Study drug 3 → Study drug 2
Group 3 (n = 4): Study drug 2 → Study drug 1 → Study drug 3
Group 4 (n = 4): Study drug 2 → Study drug 3 → Study drug 1
Group 5 (n = 4): Study drug 3 → Study drug 1 → Study drug 2
Group 6 (n = 4): Study drug 3 → Study drug 2 → Study drug 1
After each treatment period, participants will be followed for six weeks, during which seven follow-up visits will be conducted for clinical assessments and blood sampling. A washout period of at least eight weeks will be observed between treatment periods to allow for complete elimination of the study drugs from the body.
Each participant will take part in the study for about 6 months. The entire study is expected to last about 12 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Piperaquine → Artesunate-pyronaridine → Piperaquine plus artesunate-pyronaridine) | Experimental | Drug: Piperaquine, Drug: Artesunate-pyronaridine (Pyramax), Drug: Piperaquine and artesunate-pyronaridine (Pyramax) |
| Group 2 (Piperaquine → Piperaquine plus artesunate-pyronaridine → Artesunate-pyronaridine) | Experimental | Drug: Piperaquine, Drug: Artesunate-pyronaridine (Pyramax), Drug: Piperaquine and artesunate-pyronaridine (Pyramax) |
| Group 3 (Artesunate-pyronaridine → Piperaquine → Piperaquine plus artesunate-pyronaridine) | Experimental | Drug: Piperaquine, Drug: Artesunate-pyronaridine (Pyramax), Drug: Piperaquine and artesunate-pyronaridine (Pyramax) |
| Group 4 (Artesunate-pyronaridine → Piperaquine plus artesunate-pyronaridine → Piperaquine) | Experimental | Drug: Piperaquine, Drug: Artesunate-pyronaridine (Pyramax), Drug: Piperaquine and artesunate-pyronaridine (Pyramax) |
| Group 5 (Piperaquine plus artesunate-pyronaridine → Piperaquine → artesunate-pyronaridine) | Experimental | Drug: Piperaquine, Drug: Artesunate-pyronaridine (Pyramax), Drug: Piperaquine and artesunate-pyronaridine (Pyramax) |
| Group 6 (Piperaquine plus artesunate-pyronaridine → artesunate-pyronaridine → Piperaquine) | Experimental | Drug: Piperaquine, Drug: Artesunate-pyronaridine (Pyramax), Drug: Piperaquine and artesunate-pyronaridine (Pyramax) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
- Male or female non-smoker aged between 18 years to 60 years, weighting between 45 and 85 kg.
- A female is eligible to participate in this study if she is:
- Normal electrocardiogram (ECG) with QTc <450 msec.
- Willingness and ability to comply with the study protocol for the duration of the trial.
Key exclusion criteria (14 listed)
- Females who are pregnant, trying to get pregnant, or are lactating.
- The participant has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.
- A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
- Participants with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes (heart failure, hypokalemia) or with a family history of long QT syndrome, Brugada syndrome, or sudden cardiac death.
- Abnormal serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) <70 mL/min as determined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
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 |
|---|---|---|
| PiperaquinePiperaquine is an antimalarial medicine normally combined with an artemisinin derivative in the combination therapy dihydroartemisinin-piperaquine. | Drug | Group 1 (Piperaquine → Artesunate-pyronaridine → Piperaquine plus artesunate-pyronaridine), Group 2 (Piperaquine → Piperaquine plus artesunate-pyronaridine → Artesunate-pyronaridine), Group 3 (Artesunate-pyronaridine → Piperaquine → Piperaquine plus artesunate-pyronaridine), Group 4 (Artesunate-pyronaridine → Piperaquine plus artesunate-pyronaridine → Piperaquine), Group 5 (Piperaquine plus artesunate-pyronaridine → Piperaquine → artesunate-pyronaridine), Group 6 (Piperaquine plus artesunate-pyronaridine → artesunate-pyronaridine → Piperaquine) |
| Artesunate-pyronaridine (Pyramax)Artesunate-pyronaridine is a medicine that contains the active substances pyronaridine tetraphosphate and artesunate. | Drug | Group 1 (Piperaquine → Artesunate-pyronaridine → Piperaquine plus artesunate-pyronaridine), Group 2 (Piperaquine → Piperaquine plus artesunate-pyronaridine → Artesunate-pyronaridine), Group 3 (Artesunate-pyronaridine → Piperaquine → Piperaquine plus artesunate-pyronaridine), Group 4 (Artesunate-pyronaridine → Piperaquine plus artesunate-pyronaridine → Piperaquine), Group 5 (Piperaquine plus artesunate-pyronaridine → Piperaquine → artesunate-pyronaridine), Group 6 (Piperaquine plus artesunate-pyronaridine → artesunate-pyronaridine → Piperaquine) |
| Piperaquine and artesunate-pyronaridine (Pyramax)Piperaquine is an antimalarial medicine. Artesunate-pyronaridine is a medicine that contains the active substances pyronaridine tetraphosphate and artesunate. | Drug | Group 1 (Piperaquine → Artesunate-pyronaridine → Piperaquine plus artesunate-pyronaridine), Group 2 (Piperaquine → Piperaquine plus artesunate-pyronaridine → Artesunate-pyronaridine), Group 3 (Artesunate-pyronaridine → Piperaquine → Piperaquine plus artesunate-pyronaridine), Group 4 (Artesunate-pyronaridine → Piperaquine plus artesunate-pyronaridine → Piperaquine), Group 5 (Piperaquine plus artesunate-pyronaridine → Piperaquine → artesunate-pyronaridine), Group 6 (Piperaquine plus artesunate-pyronaridine → artesunate-pyronaridine → Piperaquine) |
Primary outcome
Number of adverse events
Time frame: Approximately 6 months
Adverse events will be assessed as one of safety and tolerability parameters.
Number of events concerning of abnormal electrocardiographic
Time frame: Approximately 6 months
Electrocardiographic changes especially QTc interval prolongation will be assessed as one of safety and tolerability parameters.
Number of events concerning of abnormal vital signs
Time frame: Approximately 6 months
Abnormal vital signs will be assessed as one of safety and tolerability parameters.
Number of events concerning of abnormal laboratory values
Time frame: Approximately 6 months
Abnormal laboratory values will be assessed as one of safety and tolerability parameters.
6 secondary outcomes
Area under the concentration-time curve (AUC∞)
Time frame: Approximately 6 months
Area under the concentration-time curve (AUClast)
Time frame: Approximately 6 months
Maximum concentration (Cmax)
Time frame: Approximately 6 months
Elimination clearance (CL/F)
Time frame: Approximately 6 months
Terminal elimination half-life (t1/2)
Time frame: Approximately 6 months
Apparent volume of distribution (Vd)
Time frame: Approximately 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Yes. With participant's consent, participant's clinical data and results from blood analyses stored in our database may be shared with other researchers to use in the future in accordance with the current Data Sharing Policy. However, the other researchers will not be given any information that could identify the participant.
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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.
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 Piperaquine, Artesunate-pyronaridine (Pyramax) and Piperaquine and artesunate-pyronaridine (Pyramax) in people with Malaria, run by University of Oxford at 1 site in Thailand.
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 9 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: opening soon, as of the sponsor's last update on 5 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kittiyod C Poovorawan, MD (+662 2036333, kittiyod.poo@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: Approximately 6 months). The study lists 4 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 5 Aug 2026.