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ID119031166M Safety and Tolerability for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by IlDong Pharmaceutical Co Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening (day -28 to -3) until termination (approximately day 8 for sad and day 22 for mad)
Awards & highlights

Study Summary

This trial tests if a drug is safe, works well, and affects the body in the right way in healthy people.

Who is the study for?
This trial is for healthy adults with a BMI of 18.5 to 30, normal kidney function, and no chronic diseases. It's open to both men and women who are not pregnant or breastfeeding and agree to use contraception. Up to half the participants may be of Japanese origin; the rest must be Caucasian.Check my eligibility
What is being tested?
The study is testing ID119031166M, a new drug, against a placebo (a substance with no active drug). It aims to understand how safe it is, how well tolerated it is by the body, and how the body processes it while also looking at its effects on various bodily functions.See study design
What are the potential side effects?
Since this trial involves healthy volunteers testing a new medication (ID119031166M), potential side effects are being investigated as part of the study objectives but are not specifically listed in provided information.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening (day -28 to -3) until termination (approximately day 8 for sad and day 22 for mad)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (day -28 to -3) until termination (approximately day 8 for sad and day 22 for mad) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
Secondary outcome measures
Area under curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) (AUC0-last)
Dose-normalized AUC from pre-dose (time 0) extrapolated to 24 hours (AUC0-24)
Dose-normalized AUC0-last
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: SAD: ID119031166MExperimental Treatment1 Intervention
Group II: MAD: ID119031166MExperimental Treatment1 Intervention
Group III: SAD: PlaceboPlacebo Group1 Intervention
Group IV: MAD: PlaceboPlacebo Group1 Intervention

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

YUNOVIA CO.,LTD.UNKNOWN
IlDong Pharmaceutical Co LtdLead Sponsor
52 Previous Clinical Trials
14,562 Total Patients Enrolled
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,748 Total Patients Enrolled

Media Library

ID119031166M (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05604287 — Phase 1
Healthy Subjects Research Study Groups: MAD: ID119031166M, SAD: ID119031166M, SAD: Placebo, MAD: Placebo
Healthy Subjects Clinical Trial 2023: ID119031166M Highlights & Side Effects. Trial Name: NCT05604287 — Phase 1
ID119031166M (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05604287 — Phase 1

Frequently Asked Questions

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

Are members of the 30+ age demographic eligible to join this scientific investigation?

"According to the trial's requirements, participants must be betwixt 18 and 70 years old in order to qualify for enrollment."

Answered by AI

Are there any remaining vacancies for this research project?

"Affirmative. The information present on clinicaltrials.gov attests that this research initiative, initially posted on October 10th 2022, is actively seeking participants. 78 individuals must be enrolled at a single medical centre to complete the study requirements."

Answered by AI

What is the total amount of participants being included in this research?

"Confirmed. Clinicaltrials.gov affirms that this clinical trial, which initially posted on October 10th 2022, is currently seeking participants. 78 patients will be enrolled from one site."

Answered by AI

Is SAD: ID119031166M a hazard to individuals?

"Due to the Phase 1 status of SAD: ID119031166M, our team has assigned it a score of 1 on our safety scale. This is an indication that there are limited data points available for both efficacy and security."

Answered by AI

Am I eligible to partake in this medical experiment?

"Eligibility criteria for this study requires healthy participants aged between 18 and 70 years old. A total of 78 patients are being accepted into the trial."

Answered by AI

Who else is applying?

What site did they apply to?
California Clinical trials medical group/PAREXEL
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What state do they live in?
California

Why did patients apply to this trial?

I am open to trying a treatment that may give hope to someone who needs this.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long will the trial last? Is it paid? The key questions are: What is the length of the trial?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects
2022. "Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05604287.
~8 spots leftby Jun 2024
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