SAD Study of IA-14069

ILAb

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: IA-14069; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05317741

IA-14069_1a

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, food effect, and pharmacodynamics following a single oral dose of IA-14069 in healthy male subjects.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Signed the ICF.

2. Male subjects, ≥ 18 to ≤ 55 years of age at the time of signing the ICF.

3. Overtly healthy as determined by medical evaluation including medical history, physical examination and clinical laboratory tests.

4. Body mass index (BMI) within ≥ 18.0 to ≤ 32.0 kg/m2 and body weight not less than 50 kg.

5. Pulse rate between 40 and 100 beats per minutes (bpm)

6. A 12-lead ECG consistent with normal cardiac conduction and function, including:

   • Sinus rhythm
   • QTc interval of ≤ 450 milliseconds (QT interval corrected using Fridericia correction method [QTcF])
   • QRS interval of ≤ 120 milliseconds
   • PR interval ≤ 220 milliseconds
   • Morphology consistent with healthy cardiac conduction and function

7. Non-smoker or ex-smoker for > 6 months.

8. Agree to use contraception (Appendix 1) during the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period.

Exclusion criteria

1. Resting BP systolic or diastolic > 140/90 mmHg or < 90/45 mmHg. Subjects BP may be re-checked per site SOPs.
2. Received any investigational drug or used any investigational device within 30 days or 5 half-lives whichever is longer prior to the first dosing of study drug.
3. Clinically significant history of any serious drug sensitivity or allergy, or food allergy as determined by the Investigator (i.e., requiring epinephrine or steroids to treat).
4. Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or abnormalities, or other major systemic disease that, according to the Investigator, would unduly risk the subject's safety or may impact the conduct of the study.
5. Presence of any disorder that would interfere with the swallowing, absorption, distribution, metabolism and excretion of the investigational product as judged by the Investigator. Surgery for appendicitis is acceptable.
6. Show evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases (including anti-depressant /anti-anxiety medication).
7. Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results, or may present a safety issue to that particular subject. Laboratory results may be re-checked once per Investigator's discretion.
8. Liver function test results of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥ 1.25 upper limit of normal (ULN); with an exception of subjects considered eligible to participate in the study per Investigator's discretion.
9. History of vaso-vagal syncope within 5 years.
10. History of any major surgery within 6 months.
11. History of any active infection within 30 days prior to the first dosing.
12. Known history or positive test of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody (Ab), or human immunodeficiency virus type 1 (HIV-1) or 2 (HIV-2) Ab.
13. Subjects with a positive urine nicotine/cotinine test.
14. History of alcohol abuse as judged by the Investigator within approximately 1 year prior to admission. Average weekly alcohol intake > 14 units/week or are unwilling to stop alcohol consumption from 72 hr prior to dosing and outpatient visits and throughout the in-house periods until discharged from the clinical research unit and are unwilling to limit alcohol consumption during outpatient periods. Positive alcohol test at Screening or admission (One unit of alcohol equals about 12 ounces of beer, 5 ounces of wine or 1.5 ounces of spirits).
15. History of illicit drug abuse, within approximately 1 year prior to admission or evidence of current use as judged by the Investigator. Positive drug test, including marijuana, at Screening or admission.
16. Donation or loss of > 500 mL of blood within 56 days prior to admission.
17. Chronic use of prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) prior to the first dosing per Investigator's discretion.
18. Unable to comply with the safety monitoring requirements of this clinical study or is considered by the Investigator to be an unsuitable candidate for the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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40 participants in 5 patient groups

A mg IA-14069 or Placebo

Experimental group

Treatment:

Drug: Placebo

Drug: IA-14069

B mg IA-14069 or Placebo

Experimental group

Treatment:

Drug: Placebo

Drug: IA-14069

C mg IA-14069 or Placebo

Experimental group

Description:

Period 1: Fasted condition → Period 2: Fed condition

Treatment:

Drug: Placebo

Drug: IA-14069

D mg IA-14069 or Placebo

Experimental group

Treatment:

Drug: Placebo

Drug: IA-14069

E mg IA-14069 or Placebo

Experimental group

Treatment:

Drug: Placebo

Drug: IA-14069