Healthy Male AdultsPhase 1NCT07549919
A Study to Evaluate the Effect of Food on the Bioavailability of AJ201, and Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants
A Phase 1 study testing AJ201 in people with Healthy Male Adults and Food Effect in Healthy Volunteers, run by AnnJi Pharmaceutical Co., Ltd. at 1 site in United States.
Trial summary
This is a Phase 1, randomized, single-dose, open-label, two-way crossover study to evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and pharmacokinetics of AJ201 in Japanese and White healthy male participants. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Adults, Food Effect in Healthy Volunteers
- What is being tested?
- AJ201
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2026to 27 Apr 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, non-smokers (no use of tobacco or nicotine products within 3 months prior to Screening), ≥ 18 and ≤ 55 years of age, with body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 and body weight ≥ 50.0 kg.
- Normal renal function at Screening.
- Healthy as defined by:
- The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
- The absence of a clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, depression, attempted suicide, gastrointestinal, renal, hepatic, and metabolic disease.
- Participants must be either Japanese or White.
- Able to understand the study procedures and provide signed informed consent to participate in the study.
Who cannot join
- Any clinically significant abnormal finding at physical examination.
- Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, at Screening.
- Positive urine drug screen, urine cotinine test, or alcohol breath test.
- History of significant allergic reactions to any drug.
- Clinically significant ECG abnormalities or vital signs abnormalities at Screening.
- History of drug abuse of any soft drugs or hard drugs.
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- History of alcohol abuse.
- History of smoking or uses other nicotine-containing products.
- Undergone major surgery ≤ 3 months before first study drug administration.
- History of clinically significant opportunistic infection or serious local infection or significant medical/surgical procedure or trauma or any current infection.
- Use of medications for the timeframes specified in the protocol.
- Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would interfere with the dosing procedure.
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
AnnJi Investigational Site
Los Alamitos, California, 90720
CNS Outreach, 844-424-9494, cns.outreach@cenexel.com
About this study
Official title: A Phase 1, Randomized, Single-dose, Open-label, Two-way, Crossover Study to Evaluate the Effect of Food on AJ201, and to Evaluate the Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants
This is a Phase 1, randomized, single-dose, open-label, two-way crossover study to evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and pharmacokinetics of AJ201 in Japanese and White healthy male participants.
- Being tested
- AJ201
- Keywords
- Healthy Male Adults, Healthy Volunteers, Food Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AJ201Drug
All participants are planned to be administered a single dose of AJ201 for each period (fed and fasted).
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Japanese) | Experimental | Japanese Participants Receives: Drug: AJ201 |
| Arm B (White) | Experimental | White Participants Receives: Drug: AJ201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma PK of AJ201
AUC0-24hr: Area under the concentration-time curve from zero to 24 hours under fasting and fed conditions
Measured: Pre-dose to Day 6
Plasma PK of AJ201
AUC0-last: Area under the concentration-time curve from zero to the last observed concentration under fasting and fed conditions
Measured: Pre-dose to Day 6
Plasma PK of AJ201
AUC0-inf: Area under the concentration-time curve from time zero to infinity (extrapolated) under fasting and fed conditions
Measured: Pre-dose to Day 6
Plasma PK of AJ201
Cmax: Maximal observed concentration under fasting and fed conditions
Measured: Pre-dose to Day 6
Plasma PK of AJ201
Tmax: Time when the maximal concentration is observed under fasting and fed conditions
Measured: Pre-dose to Day 6
Plasma PK of AJ201
Residual area: Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as
[1 - (AUC0-last/AUC0-inf)] x 100 under fasting and fed conditions
Measured: Pre-dose to Day 6
Plasma PK of AJ201
Tlag: Time of observation prior to the first observation with a measurable (non-zero) concentration under fasting and fed conditions
Measured: Pre-dose to Day 6
Plasma PK of AJ201
T½ el: Terminal elimination half-life under fasting and fed conditions
Measured: Pre-dose to Day 6
Plasma PK of AJ201
Kel: Terminal elimination rate constant under fasting and fed conditions
Measured: Pre-dose to Day 6
Plasma PK of AJ201
Cl/F: Apparent clearance under fasting and fed conditions
Measured: Pre-dose to Day 6
Plasma PK of AJ201
Vz/F: Apparent volume of distribution under fasting and fed conditions
Measured: Pre-dose to Day 6
Urine PK of AJ201
Ae0-24hr: Cumulative urinary excretion from time zero to 24 hours, calculated as the sum of the amounts excreted over each collection interval under fasting and fed conditions
Measured: Pre-dose to Day 7
Urine PK of AJ201
Ae0-48hr: Cumulative urinary excretion from time zero to 48 hours, calculated as the sum of the amounts excreted over each collection interval under fasting and fed conditions
Measured: Pre-dose to Day 7
Urine PK of AJ201
Ae0-last: Cumulative urinary excretion from time zero to the last observed concentrations, calculated as the sum of the amounts excreted over each collection interval under fasting and fed conditions
Measured: Pre-dose to Day 7
Urine PK of AJ201
Rmax: Maximal rate of urinary excretion, calculated by dividing the amount of drug excreted in each collection interval by the time over which it was collected under fasting and fed conditions
Measured: Pre-dose to Day 7
Urine PK of AJ201
TRmax: Time of maximal urinary excretion, calculated as the midpoint of the collection interval during which Rmax occurred under fasting and fed conditions
Measured: Pre-dose to Day 7
Urine PK of AJ201
ClR: Renal clearance, calculated as Ae0-24hr /AUC0-24hr under fasting and fed conditions
Measured: Pre-dose to Day 7
Secondary outcomes (1)
Safety and Tolerability of AJ201
Incidence and proportion of volunteers with AEs, including TEAEs and SAEs
Measured: Baseline to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start9 Apr 2026
- Primary completion22 Apr 2026 (estimated)
- Study completion27 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male AdultsStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AnnJi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549919
- Sponsor's protocol ID
- JM17-201-102
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Single-dose, Open-label, Two-way, Crossover Study to Evaluate the Effect of Food on AJ201, and to Evaluate the Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants
- ClinicalTrials.gov ID
- NCT07549919
- Acronym / sponsor ID
- JM17-201-102
- Keywords
- Healthy Male Adults, Healthy Volunteers, Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- AnnJi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 22 Apr 2026 (estimated)
- Study completion
- 27 Apr 2026 (estimated)
- First posted
- 24 Apr 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 a Phase 1, randomized, single-dose, open-label, two-way crossover study to evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and pharmacokinetics of AJ201 in Japanese and White healthy male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Japanese) | Experimental | Drug: AJ201Japanese Participants |
| Arm B (White) | Experimental | Drug: AJ201White Participants |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male, non-smokers (no use of tobacco or nicotine products within 3 months prior to Screening), ≥ 18 and ≤ 55 years of age, with body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 and body weight ≥ 50.0 kg.
- Normal renal function at Screening.
- Healthy as defined by:
- Participants must be either Japanese or White.
- Able to understand the study procedures and provide signed informed consent to participate in the study.
Key exclusion criteria (12 listed)
- Any clinically significant abnormal finding at physical examination.
- Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, at Screening.
- Positive urine drug screen, urine cotinine test, or alcohol breath test.
- History of significant allergic reactions to any drug.
- Clinically significant ECG abnormalities or vital signs abnormalities at Screening.
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 |
|---|---|---|
| AJ201All participants are planned to be administered a single dose of AJ201 for each period (fed and fasted). | Drug | Arm A (Japanese), Arm B (White) |
Primary outcome
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
AUC0-24hr: Area under the concentration-time curve from zero to 24 hours under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
AUC0-last: Area under the concentration-time curve from zero to the last observed concentration under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
AUC0-inf: Area under the concentration-time curve from time zero to infinity (extrapolated) under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
Cmax: Maximal observed concentration under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
Tmax: Time when the maximal concentration is observed under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
Residual area: Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as [1 - (AUC0-last/AUC0-inf)] x 100 under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
Tlag: Time of observation prior to the first observation with a measurable (non-zero) concentration under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
T½ el: Terminal elimination half-life under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
Kel: Terminal elimination rate constant under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
Cl/F: Apparent clearance under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
Vz/F: Apparent volume of distribution under fasting and fed conditions
Urine PK of AJ201
Time frame: Pre-dose to Day 7
Ae0-24hr: Cumulative urinary excretion from time zero to 24 hours, calculated as the sum of the amounts excreted over each collection interval under fasting and fed conditions
Urine PK of AJ201
Time frame: Pre-dose to Day 7
Ae0-48hr: Cumulative urinary excretion from time zero to 48 hours, calculated as the sum of the amounts excreted over each collection interval under fasting and fed conditions
Urine PK of AJ201
Time frame: Pre-dose to Day 7
Ae0-last: Cumulative urinary excretion from time zero to the last observed concentrations, calculated as the sum of the amounts excreted over each collection interval under fasting and fed conditions
Urine PK of AJ201
Time frame: Pre-dose to Day 7
Rmax: Maximal rate of urinary excretion, calculated by dividing the amount of drug excreted in each collection interval by the time over which it was collected under fasting and fed conditions
Urine PK of AJ201
Time frame: Pre-dose to Day 7
TRmax: Time of maximal urinary excretion, calculated as the midpoint of the collection interval during which Rmax occurred under fasting and fed conditions
Urine PK of AJ201
Time frame: Pre-dose to Day 7
ClR: Renal clearance, calculated as Ae0-24hr /AUC0-24hr under fasting and fed conditions
1 secondary outcome
Safety and Tolerability of AJ201
Time frame: Baseline to Day 12
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 24 Apr 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 AJ201 in people with Healthy Male Adults and Food Effect in Healthy Volunteers, run by AnnJi Pharmaceutical 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 7 inclusion and 12 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 24 Apr 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. 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 Andy Chen, PhD (+886223655677 ext. 801, andy.chen@ajpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma PK of AJ201 (time frame: Pre-dose to Day 6). The study lists 17 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 24 Apr 2026.