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AJ201 for Kennedy's Disease
Phase 1 & 2
Waitlist Available
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
Able to complete 2MWT with or without the aid of an assisted device at screening
Adult males aged 18 or greater with a confirmed genetic diagnosis (confirmed CAG repeat expansion in the AR gene of at least 36 repeat) of SBMA and clinical diagnosis of symptomatic muscle weakness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 3/week 2 and visit 4/week 6 at the following time points: predose and 0.5, 1, 2, 4, 8, and 12 hours postdose.
Awards & highlights
Study Summary
This trial will study a drug's safety, tolerability, and effects in people with SBMA.
Who is the study for?
Adult males over 18 with Spinal and Bulbar Muscular Atrophy (SBMA) who can walk, have moderate physical performance, agree to use two forms of birth control, and can undergo study procedures like blood draws and muscle biopsies. Excluded are those nonambulatory, allergic to curcumin analogs or excipients in AJ201, with significant cardiovascular or cerebrovascular disease, recent use of investigational products or drugs affecting muscle metabolism.Check my eligibility
What is being tested?
The trial is testing the safety and effects of a new drug called AJ201 compared to a placebo in men with SBMA. It's randomized and double-blind meaning neither the participants nor the researchers know who gets the real drug versus placebo until after results are collected.See study design
What are the potential side effects?
Since this is an early-phase trial for AJ201, specific side effects aren't listed but generally could include reactions at injection sites, gastrointestinal issues, fatigue or allergic responses. Safety monitoring will identify side effects during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk with or without help during the test.
Select...
I am a man over 18 with SBMA, confirmed by a genetic test showing at least 36 CAG repeats in the AR gene, and I have muscle weakness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 3/week 2 and visit 4/week 6 at the following time points: predose and 0.5, 1, 2, 4, 8, and 12 hours postdose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 3/week 2 and visit 4/week 6 at the following time points: predose and 0.5, 1, 2, 4, 8, and 12 hours postdose.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and proportion of subjects with AEs including SAEs and TEAEs.
Secondary outcome measures
Pharmacodynamics: Change from baseline in mutant androgen receptor protein levels in skeletal muscle in treatment vs placebo group.
Pharmacokinetics: Area Under the Curve (AUC) will be assessed
Pharmacokinetics: Maximum Plasma Concentration (Cmax) will be assessed
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Experimental: AJ201Active Control1 Intervention
Subjects taking active drug AJ201 600mg/day for 12 weeks.
Group II: Placebo ComparatorPlacebo Group1 Intervention
Subjects taking placebo for 12 weeks.
Find a Location
Who is running the clinical trial?
AnnJi Pharmaceutical Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any experimental drugs recently, except for approved COVID-19 vaccines.I can walk with or without help during the test.Your physical performance score is 26 or higher, which means you have moderate to high physical abilities.I haven't taken any muscle-affecting drugs or high-dose steroids in the last month.I am willing to undergo all required study procedures, including blood tests and muscle biopsies.I am a man over 18 with SBMA, confirmed by a genetic test showing at least 36 CAG repeats in the AR gene, and I have muscle weakness.Your heart's electrical activity, as shown in the ECG test, is not normal and could be risky for you to participate in the study. For example, if your ECG shows changes similar to those seen in SBMA patients in Italy and Japan.You have a metal implant that cannot be removed, or you are claustrophobic and cannot undergo an MRI scan.I am allergic to curcumin or ingredients in the study medication.I am using two effective birth control methods, one being a barrier method, during and 90 days after the study.I have a serious heart condition or have had a stroke.I don't have any health conditions that could make participating in the study unsafe for me.I cannot walk by myself.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Comparator
- Group 2: Experimental: AJ201
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there availability for patients to join the ongoing clinical trial?
"Clinicaltrials.gov indicates that this clinical trial, first posted on the 1st of November 2022 and last edited nine days later, is no longer accepting participants. However, there are 206 other studies presently recruiting patients for trials."
Answered by AI
How many medical sites are administering this trial presently?
"To partake in this medical trial, individuals can visit 6 different sites such as Stanford University located in Palo Alto, Mayo Clinic in Jacksonville or the University of California Irvine situated within Orange."
Answered by AI
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