Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects
- Registration Number
- NCT05604287
- Lead Sponsor
- IlDong Pharmaceutical Co Ltd
- Brief Summary
This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.
- Detailed Description
This is a Phase 1, randomized, double-blind, placebo-controlled, sequential single/repeated-dose study. This study is a dose-escalation study with healthy participants in single ascending dose (SAD) including food-effect and multiple ascending dose (MAD) cohorts to determine the highest allowable dose (HAD).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 67
- Must be Caucasian (White American of European or Latin American descent).
- Healthy participants of Japanese origin are allowed up to 50% in each MAD cohort.
- Body mass index (BMI) within the range of 18.5 to 30 kg/m^2 (inclusive) at the time of Screening.
- No congenital or chronic diseases that require treatment and without pathologic symptoms or signs on medical examinations.
- Participants with normal renal function.
- Women are eligible to participate if not pregnant, not breastfeeding. Male subjects should be willing to use 'highly effective' or 'applicable' contraceptive methods.
- Currently have an acute disease with active symptoms.
- History of melanoma or other skin issues (including, but not limited to pre-cancerous areas, atopic dermatitis, psoriasis, rosacea, excessive moles etc.).
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease and/or arrhythmias.
- History of clinically significant hypersensitivity reaction to any drugs or additives.
- History of any gastrointestinal disease.
- History of substance use disorder including history of drug abuse disorder or history of alcohol use disorder, or tobacco use disorder or excessive caffeine intake.
- Evidence of moderate or excessive alcohol consumption.
- Tested positive in viral serology tests (hepatitis B virus [HBV], hepatitis C virus [HCV], and human immunodeficiency virus [HIV]).
- Known family history or known presence of long QT syndrome.
- A history of hypokalemia.
- Use of concomitant medicines that prolong QT/QTc (QT Interval Corrected for Heart Rate).
- History of active viral hepatitis (hepatitis A, B, C, and E), or autoimmune hepatitis.
- History of Multiple Endocrine Neoplasia type 2.
- Solid organ transplantation, except corneal transplants.
- History or presence of neutropenia which is defined as absolute neutrophil count (ANC) < 1.5 at Screening and admission.
- Participants with a microalbuminuria.
- Hemoglobin levels below 12.0 g/dL at Screening or Baseline.
- White Blood Cell levels below 3.5 × 109/L at Screening or Baseline.
- Platelet count < 150,000/µL, international normalized ratio (INR) > 1.5, albumin < 3.5 g/dL
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description MAD: Placebo Placebo - SAD: ID119031166M ID119031166M - MAD: ID119031166M ID119031166M - SAD: Placebo Placebo -
- Primary Outcome Measures
Name Time Method Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 22 for MAD) To evaluate the safety and tolerability of single and multiple ascending doses of ID119031166M in healthy participants.
- Secondary Outcome Measures
Name Time Method Time of maximum plasma concentration determined directly from the concentration-time profile (Tmax) Day 1-4 for SAD and Day 1-17 for MAD To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants.Area under curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) (AUC0-last) Day 1-4 for SAD and Day 1-17 for MAD To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Dose-normalized AUC0-last Day 1-4 for SAD and Day 1-17 for MAD To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Dose-normalized Cmax Day 1-4 for SAD and Day 1-17 for MAD To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Dose-normalized AUC from pre-dose (time 0) extrapolated to 24 hours (AUC0-24) Day 1-4 for SAD and Day 1-17 for MAD To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Maximum plasma concentration determined directly from the concentration- time profile (Cmax) Day 1-4 for SAD and Day 1-17 for MAD To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants.
Trial Locations
- Locations (1)
California Clinical trials medical group/PAREXEL
🇺🇸Glendale, California, United States