Safety, tolerability, and how Amisodin is processed in healthy adults

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects

Try whether single and short daily oral doses of Amisodin are safe and how the body handles the drug in healthy adults aged 18–55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: PRG Science & Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT07221240 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 1 study gives single ascending doses (SAD) and multiple ascending doses (MAD) of oral Amisodin to about 48 healthy adults in two parts. Participants are randomized 3:1 within each cohort (six on Amisodin, two on placebo), and one SAD cohort crosses over to fed conditions to test the food effect. Safety monitoring includes adverse events, ECGs, vital signs, laboratory tests, physical exams, and C-SSRS, while blood samples are taken to measure pharmacokinetics. Dose escalation proceeds only after safety and tolerability are reviewed and confirmed by a Safety Review Committee.

Who should consider this trial

Good fit: Healthy adults 18–55 years old, females of non-childbearing potential or males who agree to contraception requirements, and who can attend the Baltimore clinic are the intended participants.

Not a fit: People with symptomatic ALS, pregnant or breastfeeding individuals, children, or those with significant medical illnesses are unlikely to receive direct clinical benefit from this healthy-volunteer Phase 1 trial.

Why it matters

Potential benefit: If Amisodin is shown to be safe and has predictable pharmacokinetics, the results could enable further testing in people with ALS and help set dosing for later trials.

How similar studies have performed: Early Phase 1 safety and PK trials for other ALS drugs have frequently shown acceptable tolerability, but such trials do not establish effectiveness against ALS.

Eligibility criteria

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.

Where this trial is running

Baltimore, Maryland

• Pharmaron, Inc. — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Claudia Jang

Conditions Amyotrophic Lateral Sclerosis