Amyotrophic Lateral SclerosisPhase 1ALSNCT07221240
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects With Amyotrophic Lateral Sclerosis
A Phase 1 study testing Amisodin in people with Amyotrophic Lateral Sclerosis, run by PRG Science & Technology Co., Ltd. at 1 site in United States.
Trial summary
Researchers will evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered Amisodin in healthy adult subjects through a randomized, double-blind, placebo-controlled Phase 1 study consisting of two parts: single ascending dose (SAD) and multiple ascending dose (MAD). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Amisodin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 3 Jul 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
- 1. Healthy, adult, male or female (of non-childbearing potential only)*, 18 55 years of age, inclusive, at the screening visit.
- Females of non-childbearing potential are defined as follows:
- Females who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
- o Hysteroscopic sterilization
- o Bilateral tubal ligation or bilateral salpingectomy
Show all 17Show fewer
- o Hysterectomy
- Bilateral oophorectomy or
- Females who are postmenopausal with amenorrhea for at least 1 year prior to the first dosing and have follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status. 2. Male subjects must follow protocol specified contraception guidance as described in Section 7.4.5 Contraception Requirements and agree to refrain from sperm donation until 90 days after the last dosing. 3. Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
- 4. Body mass index (BMI) ≥ 18.0 and < 32.0 kg/m2 at the screening visit. 5. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the PI or designee at the screening visit, including the following:
- Seated blood pressure is ≥ 90/50 mmHg and ≤ 140/90 mmHg
- Liver function tests at or below limit or normal range
- Estimated glomerular filtration rate (estimated by Modification of Diet in Renal Disease Study equation [MDRD] method) ≥ 90 mL/min/1.73 m² 6. No ECG findings of clinical significance as judged by the PI or qualified designee at the screening visit and at first check in, including each criterion as listed below:
- Normal sinus rhythm (heart rate between 40 and 100 bpm, inclusive)
- QTcF interval ≤ 450 msec (males) or ≤ 460 msec (females)
- QRS interval < 110 msec; if > 110 msec, result will be confirmed by a manual over read
- PR interval ≤ 210 msec 7. Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.
Who cannot join
- Subjects must not be enrolled in the study if they meet any of the following criteria:
- 1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- 2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. 3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study. 4. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing. 5. History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the study drug, study drug excipients, or antihistamines.
- 6. Allergy to band aids, adhesive dressing, or medical tape. 7. Female subjects of childbearing potential. 8. Female subject with a positive pregnancy test at the screening visit or at first check-in or who is lactating. 9. Positive urine drug or serum alcohol results at the screening visit or first check-in. 10. Positive results at the screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV). 11. Unable to refrain from or anticipates the use of:
- Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing.
- Any drugs known to be significant inducers of cytochrome P450s (CYP) and/or P-glycoprotein (P-gp), including St. John's Wort, for 28 days prior to the first dosing.
Show all 10Show fewer
- Any drugs that prolong the QT/QTc interval within 14 days (or 5 half lives, whichever is longer) prior to the first dosing.
- 12. Has been on a diet incompatible with the on-study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing. 13. Donation of blood or significant blood loss within 56 days prior to the first dosing. 14. Plasma donation within 7 days prior to the first dosing 15. Participation in another clinical study within 90 days prior to the first dosing.
- The 90-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
- 16. Any other reason determined by the PI or designee, in their opinion, that would prevent the subject's participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pharmaron, Inc.
Baltimore, Maryland, 21201
James Phillips, +82 051-583-8703, dntpdus@prgst.com
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects
Researchers will evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered Amisodin in healthy adult subjects through a randomized, double-blind, placebo-controlled Phase 1 study consisting of two parts: single ascending dose (SAD) and multiple ascending dose (MAD). The food effect will be assessed in one cohort in Part1. Approximately 48 healthy, adult subjects are planned to be enrolled in total. Subjects will participate in only one part and one cohort.
Read the detailed description
During this trial, a total of 48 subjects will be randomized in a 3:1 ratio (out of 8 subjects, 6 on Amisodin, 2 on placebo in each dose group). The placebo is a capsule that looks like Amisodin but contains no study drug. The use of a placebo helps to make sure that any side effects during the study are judged fairly.
In Part 1 (SAD), subjects will receive a single oral dose of Amisodin or placebo under fasting conditions, with one cohort crossing over to receive the same treatment under fed conditions to assess the effect of food. In Part 2 (MAD), subjects will receive Amisodin or placebo once daily for 7 days under fasting conditions. Dose escalation in both parts will proceed only after safety and tolerability are confirmed by the Safety Review Committee (SRC). Safety assessments will include adverse events (AEs), ECGs, vital signs, laboratory tests, physical examinations, and C-SSRS evaluations, while plasma samples will be collected to evaluate PK.
Amisodin will be administered study drug or placebo with approximately 180mL of water under fasting conditions. The capsules will be opened and mixed with 60mL of water. The contents will be stirred well to create a uniform suspension for consumption and immediately administered orally as one dose to the subject. The cup/bottle will be rinsed with an additional 60mL of water and immediately administered to the subject. A second rinse with an additional 60mL of water will be performed and immediately administered to the subject.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Amisodin, Placebo
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmisodinDrug
Administered as specified in the treatment arm.
PlaceboOther
Administered as specified in the Placebo arm.
| Study group | Role | What they receive |
|---|---|---|
| Drug: Amisodin | Experimental | Subjects who have successfully completed the screening phase will enter the treatment phase of the study and be randomized to a treatment arm. Subjects randomized to the Amisodin arm will receive orally administered Amisodin either as a single ascending dose (SAD) or multiple ascending doses (MAD) under fasting conditions, with one cohort in the SAD part crossing over to receive the same dose under fed conditions to assess the effect of food. Receives: Drug: Amisodin |
| Drug: Placebo | Placebo comparator | Subjects who have successfully completed the screening phase will enter the treatment phase of the study and be randomized to a Placebo arm. Subjects randomized to the Placebo arm will receive orally administered Placebo either as a single ascending dose (SAD) or multiple ascending doses (MAD) under fasting conditions. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of TEAEs following a single oral dose of Amisodin and placebo.
To evaluate the safety and tolerability of a single ascending dose of Amisodin in healthy adult subjects.
Measured: From signing of the informed consent form until the follow-up visit (7 days [± 1 day] after dosing).
Secondary outcomes (20)
Pharmacokinetics (PK) of Amisodin
AUC0-t-The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method.
Measured: SAD- Day 1 to Day 4 MAD- Day 1
Pharmacokinetics (PK) of Amisodin
AUC0-inf -The area under the concentration-time curve from time 0 extrapolated to infinity. AUC0-inf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Measured: SAD- Day 1 to Day 4
Pharmacokinetics (PK) of Amisodin
AUC%extrap -Percent of AUC0-inf extrapolated, represented as (1 - AUC-t/AUC-inf) ×100.
Measured: SAD- Day 1 to Day 4
Pharmacokinetics (PK) of Amisodin
CL/F - Apparent total plasma clearance after oral (extravascular) administration, calculated as Dose/AUC0-inf.
Measured: SAD- Day 1 to Day 4
Pharmacokinetics (PK) of Amisodin
Cmax-Maximum observed concentration.
Measured: SAD- Day 1 to Day 4 MAD- Day 1
Pharmacokinetics (PK) of Amisodin
Tmax -Time to reach Cmax. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value.
Measured: SAD- Day 1 to Day 4 MAD- Day 1
Pharmacokinetics (PK) of Amisodin
Tlag-Lag time- the delay between study drug administration and the onset of absorption (applicable to FE Cohort S2 only).
Measured: SAD- Day 1 to Day 4
Pharmacokinetics (PK) of Amisodin
Kel -Apparent first-order terminal elimination rate constant calculated from a semi log plot of the plasma concentration versus time curve. The parameter will be calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero plasma concentrations).
Measured: SAD- Day 1 to Day 4 MAD- Day 7
Pharmacokinetics (PK) of Amisodin
t1/2 -Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel.
Measured: SAD- Day 1 to Day 4 MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Vz/F -Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration, calculated as Dose/(AUC0-inf × Kel).
Measured: SAD- Day 1 to Day 4
Pharmacokinetics (PK) of Amisodin
Ctrough-Plasma trough concentration observed at the end of the dosing interval
Measured: MAD- Day 1 to Day 7
Pharmacokinetics (PK) of Amisodin
AUCtau -The area under the concentration-time curve during a dosing interval (tau) at steady state.
Measured: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Cmax,ss-Maximum observed concentration at steady state.
Measured: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Cmin,ss-Minimum observed/measured non-zero concentration at steady state.
Measured: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Tmax,ss-Time to reach Cmax,ss over the final dosing interval. If the maximum value occurs at more than one time point, Tmax,ss is defined as the first time point with this value.
Measured: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
CLss/F-Apparent total plasma clearance at steady state after oral (extravascular) administration, calculated as Dose/AUCtau.
Measured: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Cavg-Average plasma concentration during the dosing interval (Ratio of AUCtau to the dosing interval, tau).
Measured: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Vz,ss/F-Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration, calculated as Dose/(AUCtau × Kel).
Measured: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
RA_AUC Accumulation ratio calculated from AUCtau at steady-state and AUC0-t, following a single dose on Day 1. If AUC0-12 on Day 1 cannot be estimated, then corresponding AUC0-t values on Days 1 and 10 will be used instead (will be calculated where applicable).
Measured: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
RA_Cmax-Accumulation ratio calculated from Cmax,ss at steady-state and Cmax following a single dose on Day 1.
Measured: MAD- Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start1 Oct 2025
- Primary completion27 May 2026 (estimated)
- Study completion3 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies 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
- Model description
- The study includes SAD, MAD and a food effect cohort. While the overall study uses a parallel design, the food effect cohort is conducted using a crossover design.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PRG Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221240
- Sponsor's protocol ID
- PRG-A-001
- Acronym
- ALS
- Status last verified
- Mar 2026
- First submitted
- 30 Sep 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 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 Ascending Dose and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07221240
- Acronym / sponsor ID
- ALS / PRG-A-001
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- PRG Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 27 May 2026 (estimated)
- Study completion
- 3 Jul 2026 (estimated)
- First posted
- 27 Oct 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.
Researchers will evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered Amisodin in healthy adult subjects through a randomized, double-blind, placebo-controlled Phase 1 study consisting of two parts: single ascending dose (SAD) and multiple ascending dose (MAD). The food effect will be assessed in one cohort in Part1. Approximately 48 healthy, adult subjects are planned to be enrolled in total. Subjects will participate in only one part and one cohort.
Detailed description
During this trial, a total of 48 subjects will be randomized in a 3:1 ratio (out of 8 subjects, 6 on Amisodin, 2 on placebo in each dose group). The placebo is a capsule that looks like Amisodin but contains no study drug. The use of a placebo helps to make sure that any side effects during the study are judged fairly.
In Part 1 (SAD), subjects will receive a single oral dose of Amisodin or placebo under fasting conditions, with one cohort crossing over to receive the same treatment under fed conditions to assess the effect of food. In Part 2 (MAD), subjects will receive Amisodin or placebo once daily for 7 days under fasting conditions. Dose escalation in both parts will proceed only after safety and tolerability are confirmed by the Safety Review Committee (SRC). Safety assessments will include adverse events (AEs), ECGs, vital signs, laboratory tests, physical examinations, and C-SSRS evaluations, while plasma samples will be collected to evaluate PK.
Amisodin will be administered study drug or placebo with approximately 180mL of water under fasting conditions. The capsules will be opened and mixed with 60mL of water. The contents will be stirred well to create a uniform suspension for consumption and immediately administered orally as one dose to the subject. The cup/bottle will be rinsed with an additional 60mL of water and immediately administered to the subject. A second rinse with an additional 60mL of water will be performed and immediately administered to the subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The study includes SAD, MAD and a food effect cohort. While the overall study uses a parallel design, the food effect cohort is conducted using a crossover design.
| Arm | Type | Receives |
|---|---|---|
| Drug: Amisodin | Experimental | Drug: AmisodinSubjects who have successfully completed the screening phase will enter the treatment phase of the study and be randomized to a treatment arm. Subjects randomized to the Amisodin arm will receive orally administered Amisodin either as a single ascending dose (SAD) or multiple ascending doses (MAD) under fasting conditions, with one cohort in the SAD part crossing over to receive the same dose under fed conditions to assess the effect of food. |
| Drug: Placebo | Placebo comparator | Other: PlaceboSubjects who have successfully completed the screening phase will enter the treatment phase of the study and be randomized to a Placebo arm. Subjects randomized to the Placebo arm will receive orally administered Placebo either as a single ascending dose (SAD) or multiple ascending doses (MAD) under fasting conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
- 1. Healthy, adult, male or female (of non-childbearing potential only)*, 18 55 years of age, inclusive, at the screening visit.
- o Hysteroscopic sterilization
- o Bilateral tubal ligation or bilateral salpingectomy
- o Hysterectomy
Key exclusion criteria (10 listed)
- 1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- 2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. 3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study. 4. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing. 5. History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the study drug, study drug excipients, or antihistamines.
- 6. Allergy to band aids, adhesive dressing, or medical tape. 7. Female subjects of childbearing potential. 8. Female subject with a positive pregnancy test at the screening visit or at first check-in or who is lactating. 9. Positive urine drug or serum alcohol results at the screening visit or first check-in. 10. Positive results at the screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV). 11. Unable to refrain from or anticipates the use of:
- 12. Has been on a diet incompatible with the on-study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing. 13. Donation of blood or significant blood loss within 56 days prior to the first dosing. 14. Plasma donation within 7 days prior to the first dosing 15. Participation in another clinical study within 90 days prior to the first dosing.
- The 90-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
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 |
|---|---|---|
| AmisodinAdministered as specified in the treatment arm. | Drug | Drug: Amisodin |
| PlaceboAdministered as specified in the Placebo arm. | Other | Drug: Placebo |
Primary outcome
Number and severity of TEAEs following a single oral dose of Amisodin and placebo.
Time frame: From signing of the informed consent form until the follow-up visit (7 days [± 1 day] after dosing).
To evaluate the safety and tolerability of a single ascending dose of Amisodin in healthy adult subjects.
20 secondary outcomes
Pharmacokinetics (PK) of Amisodin
Time frame: SAD- Day 1 to Day 4 MAD- Day 1
Pharmacokinetics (PK) of Amisodin
Time frame: SAD- Day 1 to Day 4
Pharmacokinetics (PK) of Amisodin
Time frame: SAD- Day 1 to Day 4
Pharmacokinetics (PK) of Amisodin
Time frame: SAD- Day 1 to Day 4
Pharmacokinetics (PK) of Amisodin
Time frame: SAD- Day 1 to Day 4 MAD- Day 1
Pharmacokinetics (PK) of Amisodin
Time frame: SAD- Day 1 to Day 4 MAD- Day 1
Pharmacokinetics (PK) of Amisodin
Time frame: SAD- Day 1 to Day 4
Pharmacokinetics (PK) of Amisodin
Time frame: SAD- Day 1 to Day 4 MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Time frame: SAD- Day 1 to Day 4 MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Time frame: SAD- Day 1 to Day 4
Pharmacokinetics (PK) of Amisodin
Time frame: MAD- Day 1 to Day 7
Pharmacokinetics (PK) of Amisodin
Time frame: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Time frame: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Time frame: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Time frame: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Time frame: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Time frame: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Time frame: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Time frame: MAD- Day 7
Pharmacokinetics (PK) of Amisodin
Time frame: MAD- Day 7
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 Mar 2026.
- 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.
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 Amisodin in people with Amyotrophic Lateral Sclerosis, run by PRG Science & Technology Co., Ltd. at 1 site in United States.
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 17 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 5 Mar 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 United States. 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?
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 Claudia Jang (+82 051-583-8703, claudiajang@kcrnresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of TEAEs following a single oral dose of Amisodin and placebo. (time frame: From signing of the informed consent form until the follow-up visit (7 days [± 1 day] after dosing).). 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 Mar 2026.