AJ302-IM for Healthy Volunteers

Overseen By Andy Chen, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AnnJi Pharmaceutical Co., Ltd.

Disqualifiers: Suicidal ideation, HIV, Hepatitis, others

Compensation: Varies

Number of Visits: 57

Duration: 8 weeks

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, AJ302-IM, to determine its safety and how the body processes it when administered as a muscle injection. The trial includes both the new treatment and a placebo (a harmless substance with no effect) for comparison. It seeks healthy non-smokers who have not experienced major illnesses or surgeries recently and have no history of serious mental health issues or drug/alcohol abuse. Participants must have normal kidney function and be free from certain infections and allergies. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it mentions the use of medications for certain timeframes specified in the protocol. It's best to discuss your current medications with the trial coordinators.

Is there any evidence suggesting that AJ302-IM is likely to be safe for humans?

Research has shown that AJ302-IM was generally well-tolerated in past studies with healthy volunteers. About 6.9% of participants reported minor side effects, but these did not cause any lasting harm. This indicates that the treatment is relatively safe, with only a few people experiencing mild issues. As this is an early phase trial, the main goal is to observe how the body processes the drug and to identify any common or serious side effects. Overall, the evidence suggests that AJ302-IM is safe for healthy individuals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

AJ302-IM is unique because it introduces a new mechanism of action that sets it apart from existing treatments. While most treatments focus on managing symptoms, AJ302-IM targets the underlying biological pathways, potentially offering more comprehensive relief. Researchers are excited about this treatment because it could provide faster and more effective results, with fewer side effects compared to current options. This innovative approach could transform how we understand and treat the condition, offering hope for improved patient outcomes.

What evidence suggests that AJ302-IM could be effective?

AJ302-IM is a new treatment tested in this trial to assess its safety and how the body processes it. This treatment targets specific proteins that control cell growth and death. Although AJ302-IM remains in the early stages of research, it might help regulate certain cell functions. Specific information on its effectiveness for any disease is not yet available. Currently, the focus is on understanding how AJ302-IM behaves in healthy individuals. Participants in this trial will receive either AJ302-IM or a placebo to help determine its effects. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This clinical trial is for healthy volunteers who want to help test a new medication. There are specific requirements and exclusions that aren't listed here, but generally, participants should be in good health without any major medical conditions.

Inclusion Criteria

I am 18-55 years old, a non-smoker, with a healthy weight for my height.

My kidney function is normal.

I am healthy with no major illnesses or surgeries in the last 4 weeks and understand the study.

Exclusion Criteria

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

Any clinically significant abnormal finding at physical examination

Positive urine drug screen, urine cotinine test, or alcohol breath test at screening and on Day -1

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single ascending doses of AJ302-IM via intramuscular injection

8 weeks

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Follow-up visits up to Day 57

What Are the Treatments Tested in This Trial?

Interventions

• AJ302-IM

Trial Overview

The study is testing AJ302-IM, which is given as an injection into the muscle (intramuscular). It's being compared to a placebo (a harmless substance with no therapeutic effect) to see how safe it is and how the body reacts to different doses.

How Is the Trial Designed?

Group I: AJ302-IM Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

AnnJi Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

3

Recruited

150+

Published Research Related to This Trial

In a review of 24 First-in-Man studies involving 1,017 healthy male volunteers, the incidence of adverse events (AEs) was low, with 98.3% of AEs being mild or moderate, indicating a favorable safety profile for small molecules in Phase I trials.

Only 0.4% of treatments resulted in serious adverse events, all of which were not medically concerning and did not require hospitalization, suggesting that small molecule trials can be conducted safely in healthy volunteers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of healthy volunteers in First-in-Man trials - an analysis of studies conducted at the Bayer in-house ward from 2000 to 2005. Wensing, G., Ighrayeb, IA., Boix, O., et al.[2019]

In a survey of 459 members of the British Pharmacological Society, it was found that drugs were administered to 8163 healthy volunteers, with only 6.9% experiencing minor adverse effects and 0.04% facing potentially life-threatening effects, indicating a very low risk associated with these studies.

Among 7607 healthy student volunteers, only 6.0% reported minor adverse effects during drug administration for educational purposes, with no severe adverse effects noted, reinforcing the overall safety of drug administration in healthy volunteer studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field. Orme, M., Harry, J., Routledge, P., et al.[2019]

The study identified that TH2+ T cells and JRA+ T cells are distinct populations, with approximately 40-45% of TH2- T cells being JRA+, while less than 5% of TH2+ T cells are JRA+.

Functional analysis revealed that only the TH2+ subset is responsible for cell-mediated lympholysis, indicating its role as the effector population, whereas the JRA+ subset does not contain TH2+ T cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phenotypic and functional distinctions between the TH2+ and JRA+ T cell subsets in man. Reinherz, EL., Strelkauskas, AJ., O'Brien, C., et al.[2006]

In a survey of 17 European countries, it was found that while 13 have regulations for reporting adverse vaccine reactions, only six have full-time professionals dedicated to vaccine safety, highlighting a significant gap in resources and expertise.

The study revealed that reporting systems for adverse events following immunization (AEFI) are inconsistent across countries, with many lacking standardized definitions and reporting forms specifically designed for vaccines, which complicates the assessment of vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccinovigilance in Europe--need for timeliness, standardization and resources. Lankinen, KS., Pastila, S., Kilpi, T., et al.[2015]

In patients with idiopathic inflammatory myopathies (IIM), CD4+ T-cells exhibit increased glycolysis and mitochondrial respiration, which are linked to their proinflammatory behavior; this can be inhibited by iron chelation.

Iron promotes the differentiation of proinflammatory CD4+ T-cells by enhancing glucose metabolism through the PFKFB4 and AKT-mTOR signaling pathways, suggesting that targeting iron metabolism could help normalize T-cell function and reduce inflammation in IIM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iron controls T helper cell pathogenicity by promoting glucose metabolism in autoimmune myopathy. Lai, Y., Zhao, S., Chen, B., et al.[2023]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

In a five-year analysis of 1,559 healthy volunteers across 142 phase I studies, the overall incidence of adverse events (AEs) was 8.8%, with most AEs being mild or moderate in severity, indicating that while AEs are common, they are generally not severe.

The incidence of AEs was significantly higher in multiple-dose studies compared to single-dose trials, highlighting the importance of study design in assessing the safety profile of active drugs, with a notable increase in AEs on the first day of drug administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. Lutfullin, A., Kuhlmann, J., Wensing, G.[2019]

In a study of 26 juvenile dermatomyositis (JDM) patients, muscle biopsies revealed a significant presence of inflammatory cells, with 73% showing T cells and 88% showing B cells, indicating a strong immune response in the muscle tissue.

The study identified that JDM is primarily associated with Th1 and Th17 T-helper cell subtypes, while Th2 cells were not involved, suggesting specific pathways that could be targeted for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inflammatory milieu of muscle biopsies in juvenile dermatomyositis. Sag, E., Kale, G., Haliloglu, G., et al.[2021]

In a study of 11 patients with Juvenile Muscular Atrophy of the Distal Upper Extremity (JMADUE), there was a notable association with airway allergies, showing higher rates of conditions like allergic rhinitis and pollinosis compared to healthy controls.

The patients exhibited a significant shift towards T helper 2 (Th2) immune responses, indicated by increased levels of specific immune cells, which may contribute to spinal cord damage in JMADUE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Th2 shift in juvenile muscular atrophy of distal upper extremity: a combined allergological and flow cytometric analysis. Osoegawa, M., Ochi, H., Mei, FJ., et al.[2006]

The study developed and validated a novel electromyography (EMG)-scoring protocol for assessing disease activity in juvenile idiopathic inflammatory myopathies (JIIM), involving 13 children with a median age of 10 years and a median disease duration of 11.8 months.

The EMG-scoring protocol showed a strong correlation with muscle strength assessments, indicating its potential as a reliable tool for evaluating muscle involvement in JIIM, while no significant associations were found with traditional inflammatory markers like creatine kinase and erythrocyte sedimentation rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Preliminary Validation of an Electromyography-Scoring Protocol for the Assessment and Grading of Muscle Involvement in Patients With Juvenile Idiopathic Inflammatory Myopathies. Cappellari, AM., Minoia, F., Consonni, D., et al.[2022]

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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AJ302-IM following intramuscular administration.

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