Is NCT07221240 recruiting in Baltimore, MD?

Yes, NCT07221240 is currently recruiting participants at its Baltimore, MD location. This amyotrophic lateral sclerosis clinical trial is actively enrolling qualified participants.

How do I join the amyotrophic lateral sclerosis clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Amyotrophic Lateral Sclerosis Clinical Trial in Baltimore, MD

About This Amyotrophic Lateral Sclerosis Study in Baltimore

Researchers will evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered Amisodin in healthy adult subjects through a randomized, double-blind, placebo-controlled Phase 1 study consisting of two parts: single ascending dose (SAD) and multiple ascending dose (MAD). The food effect will be assessed in one cohort in Part1. Approximately 48 healthy, adult subjects are planned to be enrolled in total. Subjects will participate in only one part and one cohort.

Sponsor: PRG Science & Technology Co., Ltd.

Who Can Participate

Inclusion Criteria

Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:

1\. Healthy, adult, male or female (of non-childbearing potential only)\*, 18 55 years of age, inclusive, at the screening visit.

Females of non-childbearing potential are defined as follows:

Females who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing: o Hysteroscopic sterilization o Bilateral tubal ligation or bilateral salpingectomy o Hysterectomy

Bilateral oophorectomy or

Females who are postmenopausal with amenorrhea for at least 1 year prior to the first dosing and have follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status. 2. Male subjects must follow protocol specified contraception guidance as described in Section 7.4.5 Contraception Requirements and agree to refrain from sperm donation until 90 days after the last dosing. 3. Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting. 4\. Body mass index (BMI) ≥ 18.0 and \< 32.0 kg/m2 at the screening visit. 5. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the PI or designee at the screening visit, including the following:

Seated blood pressure is ≥ 90/50 mmHg and ≤ 140/90 mmHg

Liver function tests at or below limit or normal range

Estimated glomerular filtration rate (estimated by Modification of Diet in Renal Disease Study equation \[MDRD\] method) ≥ 90 mL/min/1.73 m² 6. No ECG findings of clinical significance as judged by the PI or qualified designee at the screening visit and at first check in, including each criterion as listed below:

Normal sinus rhythm (heart rate between 40 and 100 bpm, inclusive)

QTcF interval ≤ 450 msec (males) or ≤ 460 msec (females)

QRS interval \< 110 msec; if \> 110 msec, result will be confirmed by a manual over read

PR interval ≤ 210 msec 7. Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.

Exclusion Criteria

Subjects must not be enrolled in the study if they meet any of the following criteria:

1\. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. 2\. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. 3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study. 4. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing. 5. History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the study drug, study drug excipients, or antihistamines. 6\. Allergy to band aids, adhesive dressing, or medical tape. 7. Female subjects of childbearing potential. 8. Female subject with a positive pregnancy test at the screening visit or at first check-in or who is lactating. 9. Positive urine drug or serum alcohol results at the screening visit or first check-in. 10. Positive results at the screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV). 11. Unable to refrain from or anticipates the use of: • Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing. • Any drugs known to be significant inducers of cytochrome P450s (CYP) and/or P-glycoprotein (P-gp), including St. John's Wort, for 28 days prior to the first dosing. • Any drugs that prolong the QT/QTc interval within 14 days (or 5 half lives, whichever is longer) prior to the first dosing. 12\. Has been on a diet incompatible with the on-study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing. 13. Donation of blood or significant blood loss within 56 days prior to the first dosing. 14. Plasma donation within 7 days prior to the first dosing 15. Participation in another clinical study within 90 days prior to the first dosing. The 90-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study. 16\. Any other reason determined by the PI or designee, in their opinion, that would prevent the subject's participation in the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT07221240) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Amyotrophic Lateral Sclerosis Treatment Options in Baltimore, MD

If you're searching for amyotrophic lateral sclerosis treatment options in Baltimore, MD, this clinical trial (NCT07221240) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced amyotrophic lateral sclerosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all amyotrophic lateral sclerosis clinical trials near you to find additional studies recruiting in your area.

Amyotrophic Lateral Sclerosis Clinical Trial in Baltimore, MD

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