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Monoclonal Antibodies
AJ302-IM for Healthy Volunteers
Phase 1
Recruiting
Research Sponsored by AnnJi Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, non-smokers (no use of tobacco or nicotine products within 3 months prior to screening), aged between 18 and 55 years, with BMI between 18.5 and 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females
Be between 18 and 65 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose to day 57
Summary
This trial will test a new drug called AJ302-IM to see if it is safe and well-tolerated when given as a single injection in increasing doses to healthy volunteers.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves healthy volunteers, side effects are closely monitored. Specific side effects of AJ302-IM aren't listed here but could include reactions at the injection site, general discomfort or other symptoms that will be tracked.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18-55 years old, a non-smoker, with a healthy weight for my height.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have hepatitis B, C, or HIV based on recent tests.
Select...
I am currently pregnant or breastfeeding.
Select...
I am not allergic to HDAC6 inhibitors or any related medication ingredients.
Select...
I have had a serious infection or significant medical procedure recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose to day 57
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose to day 57
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Plasma PK of AJ302-IM
Urine PK of AJ302-IM
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AJ302-IMExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AnnJi Pharmaceutical Co., Ltd.Lead Sponsor
2 Previous Clinical Trials
97 Total Patients Enrolled