A Study of ALS-4 in Healthy Adults Subjects

NCT05274802 | Completed Phase 1 DMC

• 1 other identifier: ALS-4-2020-11-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I trial to evaluate the safety, tolerability and Pharmacokinetics of ALS-4 (IM032) in a single ascending dose (SAD) and multiple ascending dose (MAD) in healthy adult subjects.

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse Events

  An adverse event is any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the Study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product.

  Up to 28 days

Secondary Outcomes (13)

• Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUCinf)

  Up to 24 hours post dose

• Area under the plasma concentration vs time curve from time 0 to the time of the last measurable concentration, or last sampling time t (AUCt)

  Up to 24 hours post dose

• Time of maximum observed plasma concentration (Cmax)

  Up to 24 hours post dose

• Time of maximum plasma concentration (Tmax)

  Up to 24 hours post dose

• Terminal elimination rate constant (λz)

  Up to 24 hours post dose

Study Arms (9)

Part A1 (Single dose): Cohort A: ALS-4 25mg

EXPERIMENTAL

Single dose of ALS-4 or placebo before Breakfast

Drug: ALS-4; Drug: Placebo

Part A1 (Single dose): Cohort B: ALS-4 50mg

EXPERIMENTAL

Single dose of ALS-4 or placebo before Breakfast

Drug: ALS-4; Drug: Placebo

Part A1 (Single dose): Cohort C: ALS-4 100mg

EXPERIMENTAL

Single dose of ALS-4 or placebo before Breakfast

Drug: ALS-4; Drug: Placebo

Part A1 (Single dose): Cohort D: ALS-4 200mg

EXPERIMENTAL

Single dose of ALS-4 or placebo before Breakfast

Drug: ALS-4; Drug: Placebo

Part A1 (Single dose): Cohort E: ALS-4 300mg

EXPERIMENTAL

Single dose of ALS-4 or placebo before Breakfast

Drug: ALS-4; Drug: Placebo

Part A2 (Single dose): Cohort F: ALS-4 50mg

EXPERIMENTAL

Dose three separate times in crossover fashion: (1) fasted morning dose; (2) fed morning dose; (3) fasted evening dose

Drug: Placebo; Drug: ALS-4

Part B (Multiple dose): Cohort AA: ALS-4 50mg

EXPERIMENTAL

Multiple dose of ALS-4 or placebo up to two times daily

Drug: ALS-4; Drug: Placebo

Part B (Multiple dose): Cohort BB: ALS-4 100mg

EXPERIMENTAL

Multiple dose of ALS-4 or placebo up to two times daily

Drug: ALS-4; Drug: Placebo

Part B (Multiple dose): Cohort CC: ALS-4 200mg

EXPERIMENTAL

Multiple dose of ALS-4 or placebo up to two times daily

Drug: ALS-4; Drug: Placebo

Interventions

ALS-4 DRUG

Single dose of ALS-4 before Breakfast

Also known as: IM032

Part A1 (Single dose): Cohort A: ALS-4 25mg; Part A1 (Single dose): Cohort B: ALS-4 50mg; Part A1 (Single dose): Cohort C: ALS-4 100mg; Part A1 (Single dose): Cohort D: ALS-4 200mg; Part A1 (Single dose): Cohort E: ALS-4 300mg

Placebo DRUG

Single dose of placebo before Breakfast

Part A1 (Single dose): Cohort A: ALS-4 25mg; Part A1 (Single dose): Cohort B: ALS-4 50mg; Part A1 (Single dose): Cohort C: ALS-4 100mg; Part A1 (Single dose): Cohort D: ALS-4 200mg; Part A1 (Single dose): Cohort E: ALS-4 300mg; Part A2 (Single dose): Cohort F: ALS-4 50mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, non-smoking male and female volunteers (18-60 years inclusive at the time of informed consent.)
• Body mass index (BMI) within 18.5 - 33.0 kg/m2 inclusive and weight \>50 kg.
• Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
• QTc interval \< 440 milliseconds for males and \< 460 milliseconds for females, unless deemed otherwise by the PI/Sub-Investigator
• Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 55-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
• Clinical laboratory values within the most recent acceptable laboratory test range, and/or values are deemed by the PI/Sub-Investigator as "Not Clinically Significant".
• Ability to comprehend and be informed of the nature of the study, as assessed by staff. Capable of giving written informed consent prior to any study related procedure. Must be able to communicate effectively with clinic staff.
• Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
• Agree not to have a tattoo or body piercing until the end of the study.
• Subject agree to avoid pregnancy and use an acceptable highly effective method of contraception from at least 30 days prior to the study until at least 30 days after the last study procedure (IM032 or placebo).

You may not qualify if:

• Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
• Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first study drug administration, as determined by the PI/Sub-Investigator.
• Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the PI/Sub-Investigator.
• Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
• A known history or positive test result for human immunodeficiency virus (HIV), chronic Hepatitis B surface antigen, or Hepatitis C.
• A positive test result for drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol test and cotinine. Positive pregnancy test for female subjects.
• Known history or presence of Food allergies and/or presence of any dietary restrictions unless deemed by the - - PI/Sub-I as "Not Clinically Significant" or Severe allergic reactions
• Intolerance to and/or difficulty with blood sampling through venipuncture.
• Individuals who have donated, in the days prior to first study drug administration: 50-499 mL of blood in the previous 30 days; or 500 mL or more in the previous 56 days; or donation of plasma by plasmapheresis within 7 days prior to first study drug administration.
• Individuals who have participated in another clinical trial or who received an investigational drug within 30 days or 5-half-lives prior to first study drug administration.
• Use of any enzyme-modifying drugs and/or other products, including strong inhibitors of cytochrome P450 (CYP) enzymes (e.g., cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (e.g., barbiturates, carbamazepine, glucocorticoids, phenytoin, St. John´s Wort, and rifampicin) in the previous 30 days before first study drug administration.
• Use of any monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine) within 30 days prior to first study drug administration.
• Use of any prescription medication within 14 days prior to first study drug administration (except for accepted methods of contraception).
• Use of any over-the-counter medications (including oral multivitamins, herbal and/or dietary supplements) within 14 days prior to first study drug administration (except for accepted methods of contraception).
• Consumption of food or beverages containing grapefruit and/or pomelo within 10 days prior to first study drug administration.

Sponsors & Collaborators

• Aptorum International Limited: lead

Study Sites (1)

BioPharma Services Inc.

North York, Ontario, M9L 3A2, Canada

Location

Study Officials

• Thomas Lee, PhD

  Aptorum International Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 10, 2022
• Study Start: March 20, 2021
• Primary Completion: December 22, 2021
• Study Completion: January 2, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

CA (1)