Healthy SubjectPhase 1NCT05274802
A Study of ALS-4 in Healthy Adults Subjects
A Phase 1 study testing ALS-4 in people with Healthy Subject, run by Aptorum International Limited at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- ALS-4
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 20 Mar 2021to 2 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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".
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- 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).
Who cannot join
- 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.
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- 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.
- Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing.
- Individuals having undergone any major surgery within 6 months prior to the start of the study, unless deemed otherwise by PI/Sub-Investigator.
- Have any other conditions that, in the opinion of the Investigator or Sponsor, would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study.
- Have had a tattoo or body piercing within 30 days prior to first study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of ALS-4 (IM032) Administered Orally to Healthy Volunteers
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.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, first-in-human (FIH) study of ALS-4 (IM032) in healthy male and non-pregnant, non-lactating female volunteers. The study will consist of two phases: SAD and MAD. The study will evaluate the safety, tolerability and pharmacokinetic (PK) in 6 planned SAD cohorts (5 dose levels, and 1 cohort to evaluate for a potential food or circadian effect) with sentinel design (n=8 per cohort, total randomized 6 active: 2 placebo; sentinel design not applicable when a cohort with the same or a higher drug exposure has already been evaluated) and 3 planned MAD cohorts with sentinel design (n=8 per cohort, total randomized 6 active: 2 placebo).
- Conditions
- Healthy Subject
- Being tested
- ALS-4, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALS-4Drug
Also called IM032
Single dose of ALS-4 before Breakfast
PlaceboDrug
Single dose of placebo before Breakfast
ALS-4Drug
Also called IM032
Dose three separate times in crossover fashion: (1) fasted morning dose; (2) fed morning dose; (3) fasted evening dose
ALS-4Drug
Also called IM032
Multiple dose of ALS-4 up to two times daily
PlaceboDrug
Multiple dose of placebo up to two times daily
| Study group | Role | What they receive |
|---|---|---|
| Part A1 (Single dose): Cohort A: ALS-4 25mg | Experimental | Single dose of ALS-4 or placebo before Breakfast Receives: Drug: ALS-4; Drug: Placebo |
| Part A1 (Single dose): Cohort B: ALS-4 50mg | Experimental | Single dose of ALS-4 or placebo before Breakfast Receives: Drug: ALS-4; Drug: Placebo |
| Part A1 (Single dose): Cohort C: ALS-4 100mg | Experimental | Single dose of ALS-4 or placebo before Breakfast Receives: Drug: ALS-4; Drug: Placebo |
| Part A1 (Single dose): Cohort D: ALS-4 200mg | Experimental | Single dose of ALS-4 or placebo before Breakfast Receives: Drug: ALS-4; Drug: Placebo |
| Part A1 (Single dose): Cohort E: ALS-4 300mg | Experimental | Single dose of ALS-4 or placebo before Breakfast Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: ALS-4; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 28 days
Secondary outcomes (13)
Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUCinf)
Measured: 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)
Measured: Up to 24 hours post dose
Time of maximum observed plasma concentration (Cmax)
Measured: Up to 24 hours post dose
Time of maximum plasma concentration (Tmax)
Measured: Up to 24 hours post dose
Terminal elimination rate constant (λz)
Measured: Up to 24 hours post dose
Terminal elimination half-life(T1/2)
Measured: Up to 24 hours post dose
Plasma concentration at the end of the dosing interval at steady state on Day 14 (Ctau)
Measured: Up to 24 hours post dose
Minimum steady-state plasma concentration during a dosage interval on Day 14 (Cmin)
Measured: Up to 24 hours post dose
Maximum plasma concentration during a dosage interval (x = 1 or 14) (Cmax, Day x)
Measured: Up to 24 hours post dose
Area under the plasma concentration-time curve during a dosage interval on Day x (x = 1 or 14) (AUC12, Day x)
Measured: Up to 24 hours post dose
Accumulation ratio from Cmax from Day 1 to Day 14 (AR(Cmax))
Measured: Up to 24 hours post dose
Accumulation ratio from AUC from Day 1 to Day 14 (AR(AUC))
Measured: Up to 24 hours post dose
Time until maximum plasma concentration reached on Day x (x = 1 or 14) (Tmax,Day x)
Measured: Up to 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start20 Mar 2021
- Primary completion22 Dec 2021
- Study completion2 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptorum International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Lee, PhD, Principal investigator, Aptorum International Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274802
- Sponsor's protocol ID
- ALS-4-2020-11-01
- Status last verified
- Apr 2022
- First submitted
- 14 Feb 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of ALS-4 (IM032) Administered Orally to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05274802
- Acronym / sponsor ID
- ALS-4-2020-11-01
- Conditions
- Healthy Subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Aptorum International LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 2 Jan 2022 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind, placebo-controlled, first-in-human (FIH) study of ALS-4 (IM032) in healthy male and non-pregnant, non-lactating female volunteers. The study will consist of two phases: SAD and MAD. The study will evaluate the safety, tolerability and pharmacokinetic (PK) in 6 planned SAD cohorts (5 dose levels, and 1 cohort to evaluate for a potential food or circadian effect) with sentinel design (n=8 per cohort, total randomized 6 active: 2 placebo; sentinel design not applicable when a cohort with the same or a higher drug exposure has already been evaluated) and 3 planned MAD cohorts with sentinel design (n=8 per cohort, total randomized 6 active: 2 placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part A1 (Single dose): Cohort A: ALS-4 25mg | Experimental | Drug: ALS-4, Drug: PlaceboSingle dose of ALS-4 or placebo before Breakfast |
| Part A1 (Single dose): Cohort B: ALS-4 50mg | Experimental | Drug: ALS-4, Drug: PlaceboSingle dose of ALS-4 or placebo before Breakfast |
| Part A1 (Single dose): Cohort C: ALS-4 100mg | Experimental | Drug: ALS-4, Drug: PlaceboSingle dose of ALS-4 or placebo before Breakfast |
| Part A1 (Single dose): Cohort D: ALS-4 200mg | Experimental | Drug: ALS-4, Drug: PlaceboSingle dose of ALS-4 or placebo before Breakfast |
| Part A1 (Single dose): Cohort E: ALS-4 300mg | Experimental | Drug: ALS-4, Drug: PlaceboSingle dose of ALS-4 or placebo before Breakfast |
| Part A2 (Single dose): Cohort F: ALS-4 50mg | Experimental | Drug: Placebo, Drug: ALS-4Dose three separate times in crossover fashion: (1) fasted morning dose; (2) fed morning dose; (3) fasted evening dose |
| Part B (Multiple dose): Cohort AA: ALS-4 50mg | Experimental | Drug: ALS-4, Drug: PlaceboMultiple dose of ALS-4 or placebo up to two times daily |
| Part B (Multiple dose): Cohort BB: ALS-4 100mg | Experimental | Drug: ALS-4, Drug: PlaceboMultiple dose of ALS-4 or placebo up to two times daily |
| Part B (Multiple dose): Cohort CC: ALS-4 200mg | Experimental | Drug: ALS-4, Drug: PlaceboMultiple dose of ALS-4 or placebo up to two times daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALS-4Also: IM032Single dose of ALS-4 before Breakfast | Drug | 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 |
| PlaceboSingle dose of placebo before Breakfast | Drug | 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 |
| ALS-4Also: IM032Dose three separate times in crossover fashion: (1) fasted morning dose; (2) fed morning dose; (3) fasted evening dose | Drug | Part A2 (Single dose): Cohort F: ALS-4 50mg |
| ALS-4Also: IM032Multiple dose of ALS-4 up to two times daily | Drug | Part B (Multiple dose): Cohort AA: ALS-4 50mg, Part B (Multiple dose): Cohort BB: ALS-4 100mg, Part B (Multiple dose): Cohort CC: ALS-4 200mg |
| PlaceboMultiple dose of placebo up to two times daily | Drug | Part B (Multiple dose): Cohort AA: ALS-4 50mg, Part B (Multiple dose): Cohort BB: ALS-4 100mg, Part B (Multiple dose): Cohort CC: ALS-4 200mg |
Primary outcome
Number of participants with Adverse Events
Time frame: Up to 28 days
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.
13 secondary outcomes
Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUCinf)
Time frame: 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)
Time frame: Up to 24 hours post dose
Time of maximum observed plasma concentration (Cmax)
Time frame: Up to 24 hours post dose
Time of maximum plasma concentration (Tmax)
Time frame: Up to 24 hours post dose
Terminal elimination rate constant (λz)
Time frame: Up to 24 hours post dose
Terminal elimination half-life(T1/2)
Time frame: Up to 24 hours post dose
Plasma concentration at the end of the dosing interval at steady state on Day 14 (Ctau)
Time frame: Up to 24 hours post dose
Minimum steady-state plasma concentration during a dosage interval on Day 14 (Cmin)
Time frame: Up to 24 hours post dose
Maximum plasma concentration during a dosage interval (x = 1 or 14) (Cmax, Day x)
Time frame: Up to 24 hours post dose
Area under the plasma concentration-time curve during a dosage interval on Day x (x = 1 or 14) (AUC12, Day x)
Time frame: Up to 24 hours post dose
Accumulation ratio from Cmax from Day 1 to Day 14 (AR(Cmax))
Time frame: Up to 24 hours post dose
Accumulation ratio from AUC from Day 1 to Day 14 (AR(AUC))
Time frame: Up to 24 hours post dose
Time until maximum plasma concentration reached on Day x (x = 1 or 14) (Tmax,Day x)
Time frame: Up to 24 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Lee, PhD principal investigator
Aptorum International Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALS-4 in people with Healthy Subject, run by Aptorum International Limited at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.