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ID119031166M Safety and Tolerability for Healthy Subjects
Phase 1
Waitlist Available
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)
Summary
This trial is testing a new drug called ID119031166M in healthy participants to see how safe it is and how the body processes it. Researchers want to understand how the drug is absorbed, distributed, metabolized, and excreted, as well as its effects on the body.
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening (day -28 to -3) until termination (approximately day 8 for sad and day 22 for mad)
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
Secondary study objectives
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 moreTrial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments in healthy subjects often involve evaluating the pharmacokinetics (PK) and pharmacodynamics (PD) of new drugs. PK studies focus on how the drug is absorbed, distributed, metabolized, and excreted in the body, while PD studies assess the drug's biological effects and mechanisms of action.
This information is essential for determining the safety, efficacy, and optimal dosing of new treatments, ensuring that they can be safely administered to patients with specific conditions. Understanding these mechanisms helps in predicting potential side effects and interactions with other medications, ultimately guiding the development of effective and safe therapeutic interventions.
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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
2 Previous Clinical Trials
72 Total Patients Enrolled
IlDong Pharmaceutical Co LtdLead Sponsor
53 Previous Clinical Trials
14,602 Total Patients Enrolled
ParexelIndustry Sponsor
314 Previous Clinical Trials
96,719 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a gastrointestinal disease in the past.I have had low potassium levels in the past.I have had a solid organ transplant, but not a corneal transplant.I have a history of Multiple Endocrine Neoplasia type 2.I have a history of viral or autoimmune hepatitis.My kidney function is normal.I have a significant history of major health issues.I have a family history or diagnosis of long QT syndrome.I have a history of skin conditions or melanoma.I have had or currently have low white blood cell counts.I am not pregnant or breastfeeding.I am not taking medications that affect my heart's electrical cycle.I am currently experiencing symptoms from an acute illness.I don't have any long-term illnesses needing treatment.I am willing to use effective birth control methods.I am not pregnant or breastfeeding, and if male, I agree to use effective contraception.
Research Study Groups:
This trial has the following groups:- Group 1: MAD: ID119031166M
- Group 2: SAD: ID119031166M
- Group 3: SAD: Placebo
- Group 4: MAD: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.