A Phase I Dosing Study of IkT-148009.

NCT06641557 | Completed Phase 1 FDA Drug

• 1 other identifier: IkT-148009-102
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

200mg

EXPERIMENTAL

IkT-148009 will be administered as 4x50mg gelatin capsules

Drug: 200mg of Ikt-148009

Interventions

200mg of Ikt-148009 DRUG

4 50mg capsules

200mg

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subject must have all questions about the study answered and must have signed the informed consent document before any study-specific procedures are performed.
• \. 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.
• \. Female subjects must be postmenopausal or surgically sterile or sterile for other medical reason.
• \. Male subjects must agree to practice an acceptable method of highly effective birth control.
• \. 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.

You may not qualify if:

• \. Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and admission visits.
• \. Clinically significant abnormal findings on physical examination or 12-lead electrocardiogram (ECG) at the screening or admission visits.
• \. 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.
• \. History of clinically significant problems in the retina as reported by a subject
• \. eGFR \< 60 mg/mL
• \. Creatinine, Amylase and/or Lipase \> ULN
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. Use of tobacco or nicotine-containing products during the 60 days prior to screening and for the duration of the study.
• \. Any subject who has received treatment with an investigational drug during the 30 days prior to screening.
• \. Investigative site personnel or their immediate families (spouse, parent, child or sibling whether biological or legally adopted).
• \. Any subject unwilling or unable to comply with study procedures.

Sponsors & Collaborators

• ABLi Therapeutics, Inc.: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: October 15, 2024
• Study Start: February 21, 2023
• Primary Completion: March 21, 2023
• Study Completion: April 19, 2023
• Last Updated: March 11, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)