Healthy ElderlyPhase 1NCT04350177

A Study to Assess Single and Multiple Doses of IkT-148009 in Healthy Elderly Participants and Parkinson's Patients

A Phase 1 study testing IkT-148009 in people with Healthy Elderly and Parkinson Disease, run by ABLi Therapeutics, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Elderly, Parkinson Disease
What is being tested?: IkT-148009
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 101 participants
Where: 4 sitesUnited States
Study dates: 16 Feb 2021to 30 Jan 2023
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 55 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1. Subject must have all questions about the study answered and must have signed the informed consent document before any study-specific procedures are performed.
2. Men or women aged 55 to 70 years (both inclusive) of any race. 3. Subjects must be otherwise healthy and ambulatory, with no history or evidence of clinically relevant medical disorders as determined by the Investigator in consultation with the Sponsor.
4. Mini Mental State Examination (MMSE) ≥ 28 at Screening (V1) and Baseline (V2).
5. Physical examination, clinical laboratory values, vital signs (as defined in the CRU standard operating procedure [SOP]), and the electrocardiogram (ECGs) are clinically acceptable to the Investigator. Body weight ≥ 45 kg at screening and baseline visits. Body Mass Index (BMI) ≥ 18 and ≤30 kg/m2 at screening.
6. Female subjects must be postmenopausal (12 months without menses and confirmed by follicle stimulating hormone [FSH] > 40 mIU/mL) or surgically sterile (hysterectomy or bilateral oophorectomy) or sterile for other medical reason (i.e., able to document premature low ovarian reserve, birth defect, other). Women who are several years postmenopausal may be considered for enrollment even with [FSH] below this threshold.
7. Male subjects must agree to practice an acceptable method of highly effective birth control from the Screening visit, while on study and for 7 days after receiving the last dose of study drug. Highly effective methods of birth control include sexual abstinence; vasectomy; or a condom with spermicide (men) in combination with their partner's highly effective method.

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8. Males must be willing to abstain from sperm donation from the screening visit, while on study and through 30 days after receiving the last dose of study drug.
Part C:
Participants must be eligible as in Part A and B, with the following differences/additions:
9. MMSE ≥ 26 at screening (V1) and Baseline (V2) 10. Diagnosis of Parkinson's Disease (consistent with the UK PD Society Brain Bank Criteria for the Diagnosis of PD), with bradykinesia and a clear motor response to levodopa.
11. Hoehn \& Yahr staging of 3 or less in the ON state. 12. Good clinical response to levodopa as judged by participant and investigator.
13. Stable doses of all PD medications for at least 4 weeks prior to Screening. 14. Approved by an Enrollment Authorization Committee (EAC).

Who cannot join

1. Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and admission visits. Abnormalities considered to be non-clinically significant by the Investigator are acceptable.
2. Clinically significant abnormal findings on physical examination or 12-lead electrocardiogram (ECG) at the screening or admission visits. NOTE: QTcF interval of > 450 msec in males or > 470 msec in females will be the basis for exclusion from the study. Safety ECG may be repeated for confirmatory purposes if initial values obtained exceed the limits specified.
3. Significant history (within six months prior to receiving the study drug) and/or presence of clinically significant medical, surgical or psychiatric disorder. Subjects with co-morbid conditions that are stable and controlled may remain eligible (stable defined as no change in the dose or frequency of medications over the prior three months).
4. For optional lumbar puncture: participants with bleeding disorders, relevant lab abnormalities (Screening INR greater than 1.4, platelets less than 50), relevant blood dyscrasias, prior intolerance of LP, anatomical reasons preventing safe or successful collection of fluid (skin infection at site of puncture, relevant spine surgery, spinal deformity, etc), known intracranial space-occupying lesions with mass effect, posterior fossa masses, or relevant brain malformations (Arnold-Chiari malformation, etc), exam findings suggestive of increased intracranial pressure, or known allergy/sensitivity to lidocaine or its derivatives will not be eligible.
5. eGFR < 60 mL/min 6. Creatinine, Amylase and/or Lipase > ULN 7. Any malignancy in the 5 years prior to screening excluding basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated.
8. Any subject with a history, presence and/or current evidence of serologic positive result for hepatitis B surface antigen, hepatitis C antibodies, or HIV antibodies 1 or 2. Subjects considered to be cured for hepatitis C will be eligible. 9. Recent history (within previous six months prior to screening) of alcohol or drug abuse (as judged by the investigator) or has consumed > 2 alcohol drinks/day during the last three months prior to screening (one glass is approximately equivalent to: beer [284 mL], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]). Subjects that consume three glasses of alcoholic beverages per day but less than 14 glasses per week may be enrolled at the discretion of the Investigator. Positive screens for alcohol or controlled substances at the screening or admission visits will disqualify a subject from study participation.

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10. Any subject with known hypersensitivity to IkT-148009.
11. Donation of blood or acute loss of blood within 60 days prior to screening visit.
12. Any subject who has received treatment with an investigational drug during the 30 days prior to screening.
13. Investigative site personnel or their immediate families (spouse, parent, child or sibling whether biological or legally adopted).
14. Any subject unwilling or unable to comply with study procedures.
and in addition for Part C:
15. For optional lumbar puncture: participants with bleeding disorders, relevant lab abnormalities (Screening INR greater than 1.4, platelets less than 50), prior intolerance of LP, anatomical reasons preventing safe or successful collection of fluid (skin infection at site of puncture, relevant spine surgery, spinal deformity, etc), known intracranial space-occupying lesions with mass effect, posterior fossa masses, or relevant brain malformations (Arnold-Chiari malformation, etc), exam findings suggestive of increased intracranial pressure, or known allergy/sensitivity to lidocaine or its derivatives will not be eligible.
16. Diagnosis of secondary or atypical parkinsonism 17. Prior neurosurgery for PD or treatment with DUODOPA or infused apomorphine 18. Concurrent use of neuroleptic medications or other dopamine antagonists. 19. Severe or disabling fluctuations or dyskinesias that would, in the opinion of the investigator, interfere with completion of the study 20. Clinically significant hallucinations or delusions that, in the opinion of the investigator or EAC, may preclude completion of the study 21. Clinically significant orthostatic hypotension that, in the opinion of the investigator, may preclude completion of the study 22. Currently active major depression as determined by BDI-II score of >19 23. Previous surgical procedure for PD.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Quest Research Institute LLC
Farmington Hills, Michigan, 48334
Velocity Clinical Research
Hallandale, Florida, 33009
Collaborative Neuroscience Research, LLC
Long Beach, California, 90806
Hassman Research Institute
Marlton, New Jersey, 08053

Other trials in United States

About this study

Official title: A Phase I, Randomized Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Determine the Safety, Tolerability and Pharmacokinetics (PK) of IkT-148009 in Older Adult and Elderly Healthy Volunteers With Extension Into Parkinson's Patients

This study investigates the safety and tolerability of drug IkT-148009 in healthy elderly volunteers (55 to 70 years old). This first-in-human study is designed in 3 parts. In Part A, healthy participants will take a single, oral dose of IkT-148009 or placebo. Part A participants will be at the study site for approximately 4 days. In Part B, healthy participants will take an oral dose of IkT-148009 once a day for 7 days. Part B participants will be at the study site for approximately 12 days. In Part C, Parkinson\'s patients will take an oral dose of IkT-148009 once a day for 7 days. Part C participants will be at the study site for approximately 12 days.

Read the detailed description

This is a randomized, Phase 1 study in older adult or elderly healthy volunteer subjects with subsequent extension into Parkinson patients to identify the safety, tolerability, maximum tolerated dose (MTD) and the pharmacokinetic (PK) profile of IkT-148009 capsules given as single or multiple doses.

In Part A (SAD) cohorts will consist of eight (8) subjects, six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo. Sentinel dosing will be employed on the first day of each cohort, with one subject randomized to receive IkT-148009 and the other placebo. These two subjects in each cohort will be monitored for 48 hours after dosing before deciding to dose the remainder of the cohort. The other six subjects in the first cohort will be dosed approximately 48 hours later. Each cohort will be monitored for at least 48 hours before deciding whether to administer drug to the sentinel pair for the next cohort. Each cohort will be dosed at approximately weekly intervals to allow adequate time for collection and review of safety and PK data.

A Safety Review Committee (SRC) will evaluate all available safety, tolerability, and PK data for each cohort. Escalation to a next dose will be undertaken only after these data have been reviewed by the SRC and agreement reached that it is safe to increase the dose. The SRC will not receive any unblinded PK data unless they agree to unblind a subject and/or cohort based on the completed safety review.

In Part B (MAD) cohorts will consist of eight (8) subjects, six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo daily for up to seven consecutive days. Subjects in each cohort will be observed for 48 hours after their last dose before deciding to initiate the next (higher dose) cohort. Each cohort will be dosed at approximately weekly intervals in order to allow adequate time for collection and review of safety and PK data. At the discretion of the SRC, MAD cohorts may be added consisting of eligible participants with Parkinson's Disease (Part C).

In Part C (MAD with Parkinson\'s Disease) eligible PD participants will arrive the evening before initiation of study drug dosing. No Parkinsonism medications will be given after midnight, the following morning potential participants will be clinically assessed in the practically-defined OFF state using MDS-UPDRS Part III. Cohorts will consist of eight (8) subjects, six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo daily for up to seven consecutive days. Subjects in each cohort will be observed for 48 hours after their last dose before deciding to initiate the next (higher dose) cohort. Each cohort will be dosed at approximately weekly intervals in order to allow adequate time for collection and review of safety and PK data.

Conditions: Healthy Elderly, Parkinson Disease
Being tested: IkT-148009, Placebo
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IkT-148009Drug
Oral administration gelatin capsule
PlaceboDrug
Oral administration gelatin capsule

Study groups in NCT04350177
Study group	Role	What they receive
Single Ascending Dose (SAD)	Active comparator	In Part A, cohorts will consist of eight (8) subjects; six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo. Receives: Drug: IkT-148009; Drug: Placebo
Multiple Ascending Dose (MAD)	Active comparator	In Part B, cohorts will consist of eight (8) subjects; six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo. Receives: Drug: IkT-148009; Drug: Placebo
Multiple Ascending Dose (MAD) Parkinson's patients	Active comparator	In Part C, cohorts will consist of eight (8) patients; six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo. Receives: Drug: IkT-148009; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety: incidence of abnormal vital sign measurements
body temperature by mouth, blood pressure, pulse rate, pulse oximetry, respiration rate
Measured: Safety assessments performed from Day 1 through Day 14
Safety: incidence of abnormal Clinical Laboratory Data
Clinical chemistry tests will include albumin, alkaline phosphatase, total bilirubin, calcium, cholesterol, creatinine, creatinine clearance, creatinine kinase (CK), gamma-glutamyltransferase (γ-GT), glucose, lactate dehydrogenase (LDH), inorganic phosphorus, lipase, amylase, potassium, magnesium, total protein, aspartate transaminase (AST), alanine transaminase (ALT), sodium, triglycerides, urea and uric acid, bicarbonate and chloride. TSH levels will also be monitored. CBC assessments will include hemoglobin, hematocrit, red blood cell (RBC) count, reticulocyte count, white blood cells (WBC) count with differential, platelet count and PT-INR. PT-INR should be reported in both prothrombin time and international normalized ratio. Men and women will undergo additional laboratory tests for reproductive organ function to include leutenizing hormone (LH), follicle stimulating hormone (FSH), testosterone and inhibin B.
Measured: Safety assessments performed from Day 1 through Day 14
Safety: incidence of abnormal electrocardiogram [ECG]
An ECG traces the electrical activity of the heart.
Measured: Safety assessments performed from Day 1 through Day 14
Safety: C-SSRS
Columbia Suicide Severity Rating Scale questionaire
Measured: Safety assessments performed from Day 1 through Day 14
Tolerability (adverse event reporting)
Adverse events reported
Measured: Day 1 through 14 days post last dose
Pharmacokinetic AUC of IkT-148009
Area under the concentration-time curve (AUC0-∞)
Measured: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
Pharmacokinetic Cmax of IkT-148009
Maximum plasma concentration (Cmax)
Measured: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
Pharmacokinetic AUC to last time point of IkT-148009
Area under the concentration-time curve from time zero to last time point (AUC0-last)
Measured: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
Pharmacokinetic Tmax of IkT-148009
Time to reach maximum concentration (Tmax)
Measured: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
Pharmacokinetic distribution half-life of IkT-148009
The distributional half-life and terminal half-life (t1/2)
Measured: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
Pharmacokinetic trough concentration of IkT-148009
Exposure (Ctrough)
Measured: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
Pharmacokinetic concentration of IkT-148009 steady-state at maximum concentration
Exposure (Cmax SS)
Measured: Part B, C: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose.
Pharmacokinetic exposure of IkT-148009 steady-state
Exposure (AUC SS)
Measured: Part B, C: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Feb 202130 Jan 2023

First posted16 Apr 2020
Study start16 Feb 2021
Primary completion30 Oct 2022
Study completion30 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ElderlyStudies 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: Basic science
Allocation: Randomised
Intervention model: Sequential
Model description: Sentinel dosing will be employed for each cohort in Part A, with one subject randomized to receive IkT-148009 and the other placebo on the first day. These two subjects in each cohort will be monitored for 48 hours after dosing before deciding to dose the remainder of the cohort. As such, the other six subjects in the first cohort will be dosed approximately 48 hours later. Each cohort will be monitored for at least 48 hours before deciding whether to sentinel pair in the next (higher dose) cohort, and each cohort will be dosed at approximately monthly intervals in order to allow adequate time for collection and review of safety and PK data. In Part B, 8 patients will be 3:1 randomized to placebo and dosed once per day for 7 days. In Part C, 8 patients will be 3:1 randomized to placebo and dosed once per day for 7 dayts.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04350177
Sponsor's protocol ID: IkT-148009-101
Status last verified: Feb 2023
First submitted: 26 Dec 2019
Last updated: 10 Mar 2025
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Determine the Safety, Tolerability and Pharmacokinetics (PK) of IkT-148009 in Older Adult and Elderly Healthy Volunteers With Extension Into Parkinson's Patients
ClinicalTrials.gov ID: NCT04350177
Acronym / sponsor ID: IkT-148009-101
Conditions: Healthy Elderly, Parkinson Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: ABLi Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 16 Feb 2021 (actual)
Primary completion: 30 Oct 2022 (actual)
Study completion: 30 Jan 2023 (actual)
First posted: 16 Apr 2020 (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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: Sentinel dosing will be employed for each cohort in Part A, with one subject randomized to receive IkT-148009 and the other placebo on the first day. These two subjects in each cohort will be monitored for 48 hours after dosing before deciding to dose the remainder of the cohort. As such, the other six subjects in the first cohort will be dosed approximately 48 hours later. Each cohort will be monitored for at least 48 hours before deciding whether to sentinel pair in the next (higher dose) cohort, and each cohort will be dosed at approximately monthly intervals in order to allow adequate time for collection and review of safety and PK data. In Part B, 8 patients will be 3:1 randomized to placebo and dosed once per day for 7 days. In Part C, 8 patients will be 3:1 randomized to placebo and dosed once per day for 7 dayts.

Arm	Type	Receives
Single Ascending Dose (SAD)	Active comparator	Drug: IkT-148009, Drug: PlaceboIn Part A, cohorts will consist of eight (8) subjects; six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo.
Multiple Ascending Dose (MAD)	Active comparator	Drug: IkT-148009, Drug: PlaceboIn Part B, cohorts will consist of eight (8) subjects; six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo.
Multiple Ascending Dose (MAD) Parkinson's patients	Active comparator	Drug: IkT-148009, Drug: PlaceboIn Part C, cohorts will consist of eight (8) patients; six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo.

Who may qualify

Ages: 55 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

1. Subject must have all questions about the study answered and must have signed the informed consent document before any study-specific procedures are performed.
2. Men or women aged 55 to 70 years (both inclusive) of any race. 3. Subjects must be otherwise healthy and ambulatory, with no history or evidence of clinically relevant medical disorders as determined by the Investigator in consultation with the Sponsor.
4. Mini Mental State Examination (MMSE) ≥ 28 at Screening (V1) and Baseline (V2).
5. Physical examination, clinical laboratory values, vital signs (as defined in the CRU standard operating procedure [SOP]), and the electrocardiogram (ECGs) are clinically acceptable to the Investigator. Body weight ≥ 45 kg at screening and baseline visits. Body Mass Index (BMI) ≥ 18 and ≤30 kg/m2 at screening.
6. Female subjects must be postmenopausal (12 months without menses and confirmed by follicle stimulating hormone [FSH] > 40 mIU/mL) or surgically sterile (hysterectomy or bilateral oophorectomy) or sterile for other medical reason (i.e., able to document premature low ovarian reserve, birth defect, other). Women who are several years postmenopausal may be considered for enrollment even with [FSH] below this threshold.

Key exclusion criteria (14 listed)

1. Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and admission visits. Abnormalities considered to be non-clinically significant by the Investigator are acceptable.
2. Clinically significant abnormal findings on physical examination or 12-lead electrocardiogram (ECG) at the screening or admission visits. NOTE: QTcF interval of > 450 msec in males or > 470 msec in females will be the basis for exclusion from the study. Safety ECG may be repeated for confirmatory purposes if initial values obtained exceed the limits specified.
3. Significant history (within six months prior to receiving the study drug) and/or presence of clinically significant medical, surgical or psychiatric disorder. Subjects with co-morbid conditions that are stable and controlled may remain eligible (stable defined as no change in the dose or frequency of medications over the prior three months).
4. For optional lumbar puncture: participants with bleeding disorders, relevant lab abnormalities (Screening INR greater than 1.4, platelets less than 50), relevant blood dyscrasias, prior intolerance of LP, anatomical reasons preventing safe or successful collection of fluid (skin infection at site of puncture, relevant spine surgery, spinal deformity, etc), known intracranial space-occupying lesions with mass effect, posterior fossa masses, or relevant brain malformations (Arnold-Chiari malformation, etc), exam findings suggestive of increased intracranial pressure, or known allergy/sensitivity to lidocaine or its derivatives will not be eligible.
5. eGFR < 60 mL/min 6. Creatinine, Amylase and/or Lipase > ULN 7. Any malignancy in the 5 years prior to screening excluding basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated.

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
IkT-148009Oral administration gelatin capsule	Drug	Multiple Ascending Dose (MAD), Multiple Ascending Dose (MAD) Parkinson's patients, Single Ascending Dose (SAD)
PlaceboOral administration gelatin capsule	Drug	Multiple Ascending Dose (MAD), Multiple Ascending Dose (MAD) Parkinson's patients, Single Ascending Dose (SAD)

Primary outcome

Safety: incidence of abnormal vital sign measurements
Time frame: Safety assessments performed from Day 1 through Day 14
body temperature by mouth, blood pressure, pulse rate, pulse oximetry, respiration rate
Safety: incidence of abnormal Clinical Laboratory Data
Time frame: Safety assessments performed from Day 1 through Day 14
Clinical chemistry tests will include albumin, alkaline phosphatase, total bilirubin, calcium, cholesterol, creatinine, creatinine clearance, creatinine kinase (CK), gamma-glutamyltransferase (γ-GT), glucose, lactate dehydrogenase (LDH), inorganic phosphorus, lipase, amylase, potassium, magnesium, total protein, aspartate transaminase (AST), alanine transaminase (ALT), sodium, triglycerides, urea and uric acid, bicarbonate and chloride. TSH levels will also be monitored. CBC assessments will include hemoglobin, hematocrit, red blood cell (RBC) count, reticulocyte count, white blood cells (WBC) count with differential, platelet count and PT-INR. PT-INR should be reported in both prothrombin time and international normalized ratio. Men and women will undergo additional laboratory tests for reproductive organ function to include leutenizing hormone (LH), follicle stimulating hormone (FSH), testosterone and inhibin B.
Safety: incidence of abnormal electrocardiogram [ECG]
Time frame: Safety assessments performed from Day 1 through Day 14
An ECG traces the electrical activity of the heart.
Safety: C-SSRS
Time frame: Safety assessments performed from Day 1 through Day 14
Columbia Suicide Severity Rating Scale questionaire
Tolerability (adverse event reporting)
Time frame: Day 1 through 14 days post last dose
Adverse events reported
Pharmacokinetic AUC of IkT-148009
Time frame: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
Area under the concentration-time curve (AUC0-∞)
Pharmacokinetic Cmax of IkT-148009
Time frame: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
Maximum plasma concentration (Cmax)
Pharmacokinetic AUC to last time point of IkT-148009
Time frame: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
Area under the concentration-time curve from time zero to last time point (AUC0-last)
Pharmacokinetic Tmax of IkT-148009
Time frame: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
Time to reach maximum concentration (Tmax)
Pharmacokinetic distribution half-life of IkT-148009
Time frame: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
The distributional half-life and terminal half-life (t1/2)
Pharmacokinetic trough concentration of IkT-148009
Time frame: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
Exposure (Ctrough)
Pharmacokinetic concentration of IkT-148009 steady-state at maximum concentration
Time frame: Part B, C: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose.
Exposure (Cmax SS)
Pharmacokinetic exposure of IkT-148009 steady-state
Time frame: Part B, C: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose.
Exposure (AUC SS)

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 10 Mar 2025.

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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.

Howard Hassman, MD principal investigator

Hassman Research Institute

Larry Blob, MD study chair

Cognitive Research Corporation

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IkT-148009 in people with Healthy Elderly and Parkinson Disease, run by ABLi Therapeutics, Inc. at 4 sites in United States.

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 12 inclusion and 14 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 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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?

Safety: incidence of abnormal vital sign measurements (time frame: Safety assessments performed from Day 1 through Day 14). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04350177.

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 10 Mar 2025; AzTrials last refreshed its copy on 4 Nov 2026.