HealthyPhase 1NCT05317741
SAD Study of IA-14069
A Phase 1 study testing IA-14069 in people with Healthy, run by ILAb Co., Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IA-14069
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 8 Sep 2022
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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).
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- 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.
- Donation or loss of > 500 mL of blood within 56 days prior to admission.
- 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.
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, First-in-human, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Food Effect, and Pharmacodynamics Following a Single Oral Dose of IA-14069 in Healthy Male Subjects
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
- Being tested
- IA-14069, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IA-14069Drug
Subjects received IA-14069 tablet orally on Day 1.
PlaceboDrug
Subjects received matching placebo tablet orally on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| A mg IA-14069 or Placebo | Experimental | Not described Receives: Drug: IA-14069; Drug: Placebo |
| B mg IA-14069 or Placebo | Experimental | Not described Receives: Drug: IA-14069; Drug: Placebo |
| C mg IA-14069 or Placebo | Experimental | Period 1: Fasted condition → Period 2: Fed condition Receives: Drug: IA-14069; Drug: Placebo |
| D mg IA-14069 or Placebo | Experimental | Not described Receives: Drug: IA-14069; Drug: Placebo |
| E mg IA-14069 or Placebo | Experimental | Not described Receives: Drug: IA-14069; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Measured: Up to Day 14
Incidence and severity of clinical findings on physical examination
Measured: Up to Day 8
Change from baseline in vital signs: Blood pressure (Systolic/Diastolic)
Measured: Up to Day 8
Change from baseline in vital signs: Body temperature
Measured: Up to Day 8
Change from baseline in vital signs: Respiratory rate
Measured: Up to Day 8
Change from baseline in vital signs: Heart rate
Measured: Up to Day 8
Incidence and severity of clinical laboratory abnormalities
Hematology, serum chemistry and urinalysis
Measured: Up to Day 8
Change from baseline in 12-lead ECG parameters
PR, QRS, QT and QTc intervals
Measured: Up to Day 8
Secondary outcomes (10)
Maximum observed concentration (Cmax) for IA-14069
Measured: Up to Day 8
Time to maximum concentration (Tmax) for IA-14069
Measured: Up to Day 8
Area under the concentration-time curve (AUC) for IA-14069
Measured: Up to Day 8
Terminal elimination half-life (t1/2) for IA-14069
Measured: Up to Day 8
Apparent clearance (CL/F) for IA-14069
Measured: Up to Day 8
Apparent volume of distribution (Vd/F) for IA-14069
Measured: Up to Day 8
Pharmacokinetic (PK) in Food effect measured by Cmax for IA-14069
Measured: Up to Day 8
PK in Food effect measured by Tmax for IA-14069
Measured: Up to Day 8
PK in Food effect measured by AUC for IA-14069
Measured: Up to Day 8
PK in Food effect measured by t1/2 for IA-14069
Measured: Up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start23 Aug 2021
- Primary completion8 Sep 2022
- Study completion8 Sep 2022
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
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ILAb Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317741
- Sponsor's protocol ID
- IA-14069_1a
- Status last verified
- Jan 2023
- First submitted
- 27 Oct 2021
- Last updated
- 4 Jan 2023
- Results posted
- 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 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-human, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Food Effect, and Pharmacodynamics Following a Single Oral Dose of IA-14069 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05317741
- Acronym / sponsor ID
- IA-14069_1a
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ILAb Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 8 Apr 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: IA-14069, Drug: PlaceboPeriod 1: Fasted condition → Period 2: Fed condition |
| D mg IA-14069 or Placebo | Experimental | Drug: IA-14069, Drug: Placebo |
| E mg IA-14069 or Placebo | Experimental | Drug: IA-14069, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| IA-14069Subjects received IA-14069 tablet orally on Day 1. | Drug | 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 |
| PlaceboSubjects received matching placebo tablet orally on Day 1. | Drug | 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 |
Primary outcome
Incidence and severity of adverse events
Time frame: Up to Day 14
Incidence and severity of clinical findings on physical examination
Time frame: Up to Day 8
Change from baseline in vital signs: Blood pressure (Systolic/Diastolic)
Time frame: Up to Day 8
Change from baseline in vital signs: Body temperature
Time frame: Up to Day 8
Change from baseline in vital signs: Respiratory rate
Time frame: Up to Day 8
Change from baseline in vital signs: Heart rate
Time frame: Up to Day 8
Incidence and severity of clinical laboratory abnormalities
Time frame: Up to Day 8
Hematology, serum chemistry and urinalysis
Change from baseline in 12-lead ECG parameters
Time frame: Up to Day 8
PR, QRS, QT and QTc intervals
10 secondary outcomes
Maximum observed concentration (Cmax) for IA-14069
Time frame: Up to Day 8
Time to maximum concentration (Tmax) for IA-14069
Time frame: Up to Day 8
Area under the concentration-time curve (AUC) for IA-14069
Time frame: Up to Day 8
Terminal elimination half-life (t1/2) for IA-14069
Time frame: Up to Day 8
Apparent clearance (CL/F) for IA-14069
Time frame: Up to Day 8
Apparent volume of distribution (Vd/F) for IA-14069
Time frame: Up to Day 8
Pharmacokinetic (PK) in Food effect measured by Cmax for IA-14069
Time frame: Up to Day 8
PK in Food effect measured by Tmax for IA-14069
Time frame: Up to Day 8
PK in Food effect measured by AUC for IA-14069
Time frame: Up to Day 8
PK in Food effect measured by t1/2 for IA-14069
Time frame: Up to Day 8
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 4 Jan 2023.
- 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 IA-14069 in people with Healthy, run by ILAb Co., Ltd. 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 13 inclusion and 18 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 4 Jan 2023. 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?
Incidence and severity of adverse events (time frame: Up to Day 14). The study lists 8 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 4 Jan 2023.