56 Participants Needed

AJ302-IM for Healthy Volunteers

AC
Overseen ByAndy Chen, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: AnnJi Pharmaceutical Co., Ltd.

Trial Summary

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.

What safety data exists for AJ302-IM or similar treatments in healthy volunteers?

The safety of healthy volunteers in clinical trials is generally well-monitored, with minor adverse effects reported in a small percentage of participants. In a survey, minor adverse effects were reported in about 6.9% of healthy volunteers, with no lasting harm. This suggests that the risk involved in such studies is very small.12345

How is the drug AJ302-IM different from other treatments for autoimmune myopathy?

The research does not provide specific information about AJ302-IM, but it suggests that autoimmune myopathies involve complex immune responses, including T-helper cell activity. AJ302-IM may target these immune pathways differently than existing treatments, potentially offering a novel approach to managing the condition.678910

What is the purpose of this trial?

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.

Eligibility Criteria

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
See 13 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AJ302-IMExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AnnJi Pharmaceutical Co., Ltd.

Lead Sponsor

Trials
3
Recruited
150+

Findings from Research

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.
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 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.
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.
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]

References

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. [2019]
Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]
Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. [2019]
Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field. [2019]
Vaccinovigilance in Europe--need for timeliness, standardization and resources. [2015]
Iron controls T helper cell pathogenicity by promoting glucose metabolism in autoimmune myopathy. [2023]
Inflammatory milieu of muscle biopsies in juvenile dermatomyositis. [2021]
Phenotypic and functional distinctions between the TH2+ and JRA+ T cell subsets in man. [2006]
Th2 shift in juvenile muscular atrophy of distal upper extremity: a combined allergological and flow cytometric analysis. [2006]
10.United Statespubmed.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. [2022]
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