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IA-14069 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by ILAb Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Signed the ICF.
Male subjects, ≥ 18 to ≤ 55 years of age at the time of signing the ICF.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 14
Awards & highlights

Study Summary

This trial will test the effects of a new drug in healthy male subjects. The goal is to see if it is safe and tolerated, how it is processed by the body, and what effects it has.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in 12-lead ECG parameters
Change from baseline in vital signs: Blood pressure (Systolic/Diastolic)
Change from baseline in vital signs: Body temperature
+5 more
Secondary outcome measures
Apparent clearance (CL/F) for IA-14069
Apparent volume of distribution (Vd/F) for IA-14069
Area under the concentration-time curve (AUC) for IA-14069
+7 more
Other outcome measures
Change from baseline in concentration of Tumor necrosis factor in blood

Trial Design

5Treatment groups
Experimental Treatment
Group I: E mg IA-14069 or PlaceboExperimental Treatment2 Interventions
Group II: D mg IA-14069 or PlaceboExperimental Treatment2 Interventions
Group III: C mg IA-14069 or PlaceboExperimental Treatment2 Interventions
Period 1: Fasted condition → Period 2: Fed condition
Group IV: B mg IA-14069 or PlaceboExperimental Treatment2 Interventions
Group V: A mg IA-14069 or PlaceboExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
IA-14069
2021
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ILAb Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial offer participation for those aged 40 and above?

"This study demands that applicants meet the age criteria of 18 to 55 years old. For minors, there are an additional 50 studies available and 373 for those above pensionable age."

Answered by AI

Are individuals able to participate in this experiment currently?

"Affirmative. Clinicaltrials.gov displays that this clinical research, initially published on August 23rd 2021, is currently seeking participants. The project necessitates recruiting 48 test subjects from a single medical centre."

Answered by AI

Are there any potential risks associated with IA-14069?

"Due to the limited research surrounding IA-14069, our team has assigned a safety ranking of 1 on a scale from one to three. This is because this trial is currently in Phase 1 and there are only preliminary findings regarding efficacy and safety."

Answered by AI

How many individuals are signed up for participation in this medical experiment?

"Affirmative. Clinicaltrials.gov's records confirm that this clinical trial is actively searching for participants, which was first published on August 23rd 2021 and revised most recently on September 6th 2022. A maximum of 48 patients will be accepted from one location."

Answered by AI

Is there a predetermined demographic that is eligible for this clinical trial?

"This study is open to individuals aged between 18 and 55 with a BMI of between 18.0-32.0 kg/m2, body weight not less than 50kg, heart rate in the 40-100 beats per minute range, normal sinus rhythm, QT interval corrected by Fridericia's correction method to ≤450 milliseconds, QRS interval ≤120 milliseconds and PR interval ≤220 milliseconds; all indicating healthy cardiac conduction and function. In addition those wishing to participate must have signed an ICF form confirming their eligibility for inclusion as a healthy subject (hs)."

Answered by AI
~11 spots leftby Mar 2025