Healthy VolunteersPhase 1NCT06625541
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJ302-IM in Healthy Volunteers
A Phase 1 study testing AJ302-IM in people with Healthy Volunteers, run by AnnJi Pharmaceutical Co., Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AJ302-IM following intramuscular administration of single ascending doses in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AJ302-IM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2024to 15 Aug 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, non-smokers (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 55years of age, with body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- 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 clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, depression, attempted suicide, gastrointestinal, renal, hepatic, and metabolic disease.
- 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
- Any lifetime suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) in the 2 years before screening based on the C-SSRS
- 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 pregnancy test or lactating female volunteers
- Positive urine drug screen, urine cotinine test, or alcohol breath test at screening and on Day -1
- History of significant allergic reactions to any drug
Show all 16Show fewer
- Known allergy or hypersensitivity to histone deacetylase 6 (HDAC6) inhibitors or its derivatives and/or any study product excipients
- Clinically significant ECG abnormalities or vital signs abnormalities at screening
- History of drug abuse or recreational use of soft drugs or hard drugs
- History of alcohol abuse
- History of smoking or uses other nicotine-containing products
- Undergone major surgery ≤ 2 months before 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
- Received any investigational drug or any investigational device or any biological product within the timeframes specified in the protocol
- Tattoos, sunburn, scarring or anything that may interfere with evaluation of the injection site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of AJ302-IM in Healthy Volunteers Via Intramuscular Injection
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AJ302-IM following intramuscular administration of single ascending doses in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- AJ302-IM, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AJ302-IMDrug
7 cohorts (7 dose levels) of participants are planned to be dosed.
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| AJ302-IM | Experimental | Not described Receives: Drug: AJ302-IM |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and proportion of volunteers with AEs including TEAEs and SAEs
Measured: Baseline up to Day 57
Secondary outcomes (14)
Plasma PK of AJ302-IM
AUC0-168hr: Area under the plasma concentration-time curve from zero to 168 hours
Measured: Pre-dose to Day 57
Plasma PK of AJ302-IM
AUC0-inf: Area under the concentration-time curve from time zero to infinity (extrapolated)
Measured: Pre-dose to Day 57
Plasma PK of AJ302-IM
AUC0-last: Area under the plasma concentration-time curve from zero to the last observed concentrations
Measured: Pre-dose to Day 57
Plasma PK of AJ302-IM
Cmax: Maximal observed concentration
Measured: Pre-dose to Day 57
Plasma PK of AJ302-IM
Tmax: Time when the maximal concentration is observed
Measured: Pre-dose to Day 57
Plasma PK of AJ302-IM
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
Measured: Pre-dose to Day 57
Plasma PK of AJ302-IM
T½ el: Terminal elimination half-life
Measured: Pre-dose to Day 57
Plasma PK of AJ302-IM
Kel: Terminal elimination rate constant
Measured: Pre-dose to Day 57
Plasma PK of AJ302-IM
Cl/F: Apparent clearance
Measured: Pre-dose to Day 57
Plasma PK of AJ302-IM
Vz/F: Apparent volume of distribution
Measured: Pre-dose to Day 57
Urine PK of AJ302-IM
Ae0-168hr: Cumulative urinary excretion from time zero to 168 hours, calculated as the sum of the amounts excreted over each collection interval
Measured: Pre-dose to Day 8
Urine PK of AJ302-IM
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
Measured: Pre-dose to Day 8
Urine PK of AJ302-IM
TRmax: Time of maximal urinary excretion, calculated as the midpoint of the collection interval during which Rmax occurred
Measured: Pre-dose to Day 8
Urine PK of AJ302-IM
ClR: Renal clearance, calculated as Ae0-168hr /AUC0-168hr
Measured: Pre-dose to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start24 Jun 2024
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
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
- NCT06625541
- Sponsor's protocol ID
- AJ79009-302IM-101
- Status last verified
- Dec 2025
- First submitted
- 14 Aug 2024
- Last updated
- 29 Dec 2025
- 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 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of AJ302-IM in Healthy Volunteers Via Intramuscular Injection
- ClinicalTrials.gov ID
- NCT06625541
- Acronym / sponsor ID
- AJ79009-302IM-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- AnnJi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 3 Oct 2024 (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.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AJ302-IM following intramuscular administration of single ascending doses in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AJ302-IM | Experimental | Drug: AJ302-IM |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female, non-smokers (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 55years of age, with body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- Normal renal function at screening.
- Healthy as defined by:
- Able to understand the study procedures and provide signed informed consent to participate in the study
Key exclusion criteria (16 listed)
- Any clinically significant abnormal finding at physical examination
- Any lifetime suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) in the 2 years before screening based on the C-SSRS
- 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 pregnancy test or lactating female volunteers
- Positive urine drug screen, urine cotinine test, or alcohol breath test at screening and on Day -1
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 |
|---|---|---|
| AJ302-IM7 cohorts (7 dose levels) of participants are planned to be dosed. | Drug | AJ302-IM |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Incidence and proportion of volunteers with AEs including TEAEs and SAEs
Time frame: Baseline up to Day 57
14 secondary outcomes
Plasma PK of AJ302-IM
Time frame: Pre-dose to Day 57
Plasma PK of AJ302-IM
Time frame: Pre-dose to Day 57
Plasma PK of AJ302-IM
Time frame: Pre-dose to Day 57
Plasma PK of AJ302-IM
Time frame: Pre-dose to Day 57
Plasma PK of AJ302-IM
Time frame: Pre-dose to Day 57
Plasma PK of AJ302-IM
Time frame: Pre-dose to Day 57
Plasma PK of AJ302-IM
Time frame: Pre-dose to Day 57
Plasma PK of AJ302-IM
Time frame: Pre-dose to Day 57
Plasma PK of AJ302-IM
Time frame: Pre-dose to Day 57
Plasma PK of AJ302-IM
Time frame: Pre-dose to Day 57
Urine PK of AJ302-IM
Time frame: Pre-dose to Day 8
Urine PK of AJ302-IM
Time frame: Pre-dose to Day 8
Urine PK of AJ302-IM
Time frame: Pre-dose to Day 8
Urine PK of AJ302-IM
Time frame: Pre-dose to Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- 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. 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 AJ302-IM in people with 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 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and proportion of volunteers with AEs including TEAEs and SAEs (time frame: Baseline up to Day 57). 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 29 Dec 2025.