HealthyPhase 1NCT06641557
A Phase I Dosing Study of IkT-148009.
A Phase 1 study testing 200mg of Ikt-148009 in people with Healthy, run by ABLi Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety, tolerability and pharmacokinetic (PK) profile of IkT-148009 capsules given as multiple capsules. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 200mg of Ikt-148009
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2023to 19 Apr 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 45 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 45 to 70 years at screening (both inclusive) of any race. 3. Subjects must be otherwise healthy and ambulatory, with no history or evidence of clinically relevant medical disorders 4. Mini Mental State Examination (MMSE) ≥ 28 5. Physical examination, clinical laboratory values, vital signs, and the electrocardiogram (ECGs) are clinically acceptable to the Investigator. Body weight ≥ 45 kg. Body Mass Index (BMI) ≥ 18 and ≤33 kg/m2.
- 6. Female subjects must be postmenopausal or surgically sterile or sterile for other medical reason.
- 7. Male subjects must agree to practice an acceptable method of highly effective birth control.
- 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.
Who cannot join
- 1. Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and admission visits.
- 2. Clinically significant abnormal findings on physical examination or 12-lead electrocardiogram (ECG) at the screening or admission visits.
- 3. Significant history (within six months prior to receiving the study drug) and/or presence of clinically significant medical, surgical or psychiatric disorder in the judgement of the investigator.
- 4. History of clinically significant problems in the retina as reported by a subject
- 5. eGFR < 60 mg/mL
- 6. Creatinine, Amylase and/or Lipase > ULN
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- 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.
- 10. Any subject with known hypersensitivity to IkT-148009. 11. Donation of blood, plasma, or acute loss of blood within 60 days prior to screening visit.
- 12. Use of tobacco or nicotine-containing products during the 60 days prior to screening and for the duration of the study.
- 13. Any subject who has received treatment with an investigational drug during the 30 days prior to screening.
- 14. Investigative site personnel or their immediate families (spouse, parent, child or sibling whether biological or legally adopted).
- 15. Any subject unwilling or unable to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, 7-Day Dosing Study of 200 Mg IkT-148009 to Determine the Safety, Tolerability and Pharmacokinetics (PK) of IkT-148009 in Older Adult and Elderly Healthy Volunteers
This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety, tolerability and pharmacokinetic (PK) profile of IkT-148009 capsules given as multiple capsules.
Read the detailed description
This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety, tolerability and pharmacokinetic (PK) profile of IkT-148009 capsules given as multiple capsules.
This is a single arm study with subjects to treatment with IkT-148009 only. The study will consist of a total of up to 15 visits over a period of up to 29 days prior to dosing, 7 days of dosing and 14 days of follow up.
Subjects will receive a single daily dose of study drug with a meal for a period of up to 7 days. A full breakfast must be consumed prior to receiving the dose study drug. Subjects will be confined to the unit for approximately 12 days.
- Conditions
- Healthy
- Being tested
- 200mg of Ikt-148009
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200mg of Ikt-148009Drug
4 50mg capsules
| Study group | Role | What they receive |
|---|---|---|
| 200mg | Experimental | IkT-148009 will be administered as 4x50mg gelatin capsules Receives: Drug: 200mg of Ikt-148009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Safety
Adverse event reporting
Measured: Through study completion, an average of 50 days
Participant Safety - vital signs
Changes in vital sign measurements including HR and blood pressure.
Measured: Through study completion, an average of 50 days
Participant Safety - clinical lab values
Changes in clinical laboratory data consisting of CBC, Serum Chemistry, FSH.
Measured: Through study completion, an average of 50 days
Participant Safety
Electrocardiogram [ECG] parameters of ventricular rate, RR or PR interval, QRS complex, and QTcF interval.
Measured: Through study completion, an average of 50 days
Participant Safety
C-SSRS assessment values.
Measured: Through study completion, an average of 50 days
Participant Tolerability
Percent completers
Measured: Through study completion, an average of 50 days
Assess the pharmacokinetics (PK) of IkT-148009
Pharmacokinetic parameters:
- Area under the concentration-time curve from time zero to 96 hours (AUC0-∞)
Measured: Through study completion, an average of 50 days
Assess the pharmacokinetics (PK) of IkT-148009
Pharmacokinetic parameters:
- Maximum plasma concentration (Cmax)
Measured: Through study completion, an average of 50 days
Assess the pharmacokinetics (PK) of IkT-148009
Pharmacokinetic parameters:
- Area under the concentration-time curve from time zero to last time point (AUC0-last)
Measured: Through study completion, an average of 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start21 Feb 2023
- Primary completion21 Mar 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- ABLi Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641557
- Sponsor's protocol ID
- IkT-148009-102
- Status last verified
- Oct 2024
- First submitted
- 12 Sep 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, 7-Day Dosing Study of 200 Mg IkT-148009 to Determine the Safety, Tolerability and Pharmacokinetics (PK) of IkT-148009 in Older Adult and Elderly Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06641557
- Acronym / sponsor ID
- IkT-148009-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- ABLi Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 15 Oct 2024 (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.
This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety, tolerability and pharmacokinetic (PK) profile of IkT-148009 capsules given as multiple capsules.
Detailed description
This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety, tolerability and pharmacokinetic (PK) profile of IkT-148009 capsules given as multiple capsules.
This is a single arm study with subjects to treatment with IkT-148009 only. The study will consist of a total of up to 15 visits over a period of up to 29 days prior to dosing, 7 days of dosing and 14 days of follow up.
Subjects will receive a single daily dose of study drug with a meal for a period of up to 7 days. A full breakfast must be consumed prior to receiving the dose study drug. Subjects will be confined to the unit for approximately 12 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 200mg | Experimental | Drug: 200mg of Ikt-148009IkT-148009 will be administered as 4x50mg gelatin capsules |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 45 to 70 years at screening (both inclusive) of any race. 3. Subjects must be otherwise healthy and ambulatory, with no history or evidence of clinically relevant medical disorders 4. Mini Mental State Examination (MMSE) ≥ 28 5. Physical examination, clinical laboratory values, vital signs, and the electrocardiogram (ECGs) are clinically acceptable to the Investigator. Body weight ≥ 45 kg. Body Mass Index (BMI) ≥ 18 and ≤33 kg/m2.
- 6. Female subjects must be postmenopausal or surgically sterile or sterile for other medical reason.
- 7. Male subjects must agree to practice an acceptable method of highly effective birth control.
- 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.
Key exclusion criteria (14 listed)
- 1. Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and admission visits.
- 2. Clinically significant abnormal findings on physical examination or 12-lead electrocardiogram (ECG) at the screening or admission visits.
- 3. Significant history (within six months prior to receiving the study drug) and/or presence of clinically significant medical, surgical or psychiatric disorder in the judgement of the investigator.
- 4. History of clinically significant problems in the retina as reported by a subject
- 5. eGFR < 60 mg/mL
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 |
|---|---|---|
| 200mg of Ikt-1480094 50mg capsules | Drug | 200mg |
Primary outcome
Participant Safety
Time frame: Through study completion, an average of 50 days
Adverse event reporting
Participant Safety - vital signs
Time frame: Through study completion, an average of 50 days
Changes in vital sign measurements including HR and blood pressure.
Participant Safety - clinical lab values
Time frame: Through study completion, an average of 50 days
Changes in clinical laboratory data consisting of CBC, Serum Chemistry, FSH.
Participant Safety
Time frame: Through study completion, an average of 50 days
Electrocardiogram [ECG] parameters of ventricular rate, RR or PR interval, QRS complex, and QTcF interval.
Participant Safety
Time frame: Through study completion, an average of 50 days
C-SSRS assessment values.
Participant Tolerability
Time frame: Through study completion, an average of 50 days
Percent completers
Assess the pharmacokinetics (PK) of IkT-148009
Time frame: Through study completion, an average of 50 days
Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to 96 hours (AUC0-∞)
Assess the pharmacokinetics (PK) of IkT-148009
Time frame: Through study completion, an average of 50 days
Pharmacokinetic parameters: • Maximum plasma concentration (Cmax)
Assess the pharmacokinetics (PK) of IkT-148009
Time frame: Through study completion, an average of 50 days
Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to last time point (AUC0-last)
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 11 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 200mg of Ikt-148009 in people with Healthy, run by ABLi Therapeutics, Inc. at 1 site 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 5 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 11 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 1 site 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?
Participant Safety (time frame: Through study completion, an average of 50 days). The study lists 9 primary outcomes in all. 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 11 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.