A Phase I Dosing Study of IkT-148009.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 200mg of Ikt-148009

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

  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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 200mg; IkT-148009 will be administered as 4x50mg gelatin capsules	Drug: 200mg of Ikt-148009; 4 50mg capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Safety	Adverse event reporting	Through study completion, an average of 50 days
Participant Safety - vital signs	Changes in vital sign measurements including HR and blood pressure.	Through study completion, an average of 50 days
Participant Safety - clinical lab values	Changes in clinical laboratory data consisting of CBC, Serum Chemistry, FSH.	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.	Through study completion, an average of 50 days
Participant Safety	C-SSRS assessment values.	Through study completion, an average of 50 days
Participant Tolerability	Percent completers	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-∞)	Through study completion, an average of 50 days
Assess the pharmacokinetics (PK) of IkT-148009	Pharmacokinetic parameters: • Maximum plasma concentration (Cmax)	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)	Through study completion, an average of 50 days

Collaborators and Investigators

• Sponsor: ABLi Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Actual): March 21, 2023
• Study Completion (Actual): April 19, 2023

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IkT-148009-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No