SAD Study of IA-14069

NCT05317741 | Completed Phase 1 FDA Drug

• 1 other identifier: IA-14069_1a
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• Incidence and severity of adverse events

  Up to Day 14

• Incidence and severity of clinical findings on physical examination

  Up to Day 8

• Change from baseline in vital signs: Blood pressure (Systolic/Diastolic)

  Up to Day 8

• Change from baseline in vital signs: Body temperature

  Up to Day 8

• Change from baseline in vital signs: Respiratory rate

  Up to Day 8

• Change from baseline in vital signs: Heart rate

  Up to Day 8

• Incidence and severity of clinical laboratory abnormalities

  Hematology, serum chemistry and urinalysis

  Up to Day 8

• Change from baseline in 12-lead ECG parameters

  PR, QRS, QT and QTc intervals

  Up to Day 8

Secondary Outcomes (10)

• Maximum observed concentration (Cmax) for IA-14069

  Up to Day 8

• Time to maximum concentration (Tmax) for IA-14069

  Up to Day 8

• Area under the concentration-time curve (AUC) for IA-14069

  Up to Day 8

• Terminal elimination half-life (t1/2) for IA-14069

  Up to Day 8

• Apparent clearance (CL/F) for IA-14069

  Up to Day 8

Other Outcomes (1)

• Change from baseline in concentration of Tumor necrosis factor in blood

  Up to Day 8

Study Arms (5)

A mg IA-14069 or Placebo

EXPERIMENTAL

Drug: IA-14069; Drug: Placebo

B mg IA-14069 or Placebo

EXPERIMENTAL

Drug: IA-14069; Drug: Placebo

C mg IA-14069 or Placebo

EXPERIMENTAL

Period 1: Fasted condition → Period 2: Fed condition

Drug: IA-14069; Drug: Placebo

D mg IA-14069 or Placebo

EXPERIMENTAL

Drug: IA-14069; Drug: Placebo

E mg IA-14069 or Placebo

EXPERIMENTAL

Drug: IA-14069; Drug: Placebo

Interventions

IA-14069 DRUG

Subjects received IA-14069 tablet orally on Day 1.

A mg IA-14069 or Placebo; B mg IA-14069 or Placebo; C mg IA-14069 or Placebo; D mg IA-14069 or Placebo; E mg IA-14069 or Placebo

Placebo DRUG

Subjects received matching placebo tablet orally on Day 1.

A mg IA-14069 or Placebo; B mg IA-14069 or Placebo; C mg IA-14069 or Placebo; D mg IA-14069 or Placebo; E mg IA-14069 or Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed the ICF.
• Male subjects, ≥ 18 to ≤ 55 years of age at the time of signing the ICF.
• Overtly healthy as determined by medical evaluation including medical history, physical examination and clinical laboratory tests.
• Body mass index (BMI) within ≥ 18.0 to ≤ 32.0 kg/m2 and body weight not less than 50 kg.
• Pulse rate between 40 and 100 beats per minutes (bpm)
• 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
• Non-smoker or ex-smoker for \> 6 months.
• 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.

You may not qualify if:

• Resting BP systolic or diastolic \> 140/90 mmHg or \< 90/45 mmHg. Subjects BP may be re-checked per site SOPs.
• 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.
• 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).
• 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.
• 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.
• Show evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases (including anti-depressant /anti-anxiety medication).
• 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.
• 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.
• History of vaso-vagal syncope within 5 years.
• History of any major surgery within 6 months.
• History of any active infection within 30 days prior to the first dosing.
• 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.
• Subjects with a positive urine nicotine/cotinine test.
• 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).
• 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.

Sponsors & Collaborators

• ILAb Co., Ltd.: lead

Study Sites (1)

ICON plc.

Lenexa, Kansas, 66219, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: April 8, 2022
• Study Start: August 23, 2021
• Primary Completion: September 8, 2022
• Study Completion: September 8, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)