Clinical trial NCT05604287: Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects
Official title: A Placebo-controlled, Randomized, Double-blind, Single and Multiple Dose-escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects in Healthy Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: First-in-human (FIH)
Single ascending doses (SAD)
Multiple ascending doses (MAD)
Farnesoid X receptor (FXR) agonist
Noncirrhotic non-alcoholic steatohepatitis (NASH)
Liver fibrosis
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
Collaborators: name: Parexel
name: YUNOVIA CO.,LTD.
First posted: 2022-11-03
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
timeFrame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 22 for MAD)
Secondary outcomes:
measure: Maximum plasma concentration determined directly from the concentration- time profile (Cmax)
timeFrame: Day 1-4 for SAD and Day 1-17 for MAD
measure: Time of maximum plasma concentration determined directly from the concentration-time profile (Tmax)
timeFrame: Day 1-4 for SAD and Day 1-17 for MAD
measure: Area under curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) (AUC0-last)
timeFrame: Day 1-4 for SAD and Day 1-17 for MAD
measure: Dose-normalized Cmax
timeFrame: Day 1-4 for SAD and Day 1-17 for MAD
measure: Dose-normalized AUC from pre-dose (time 0) extrapolated to 24 hours (AUC0-24)
timeFrame: Day 1-4 for SAD and Day 1-17 for MAD
measure: Dose-normalized AUC0-last
timeFrame: Day 1-4 for SAD and Day 1-17 for MAD
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical trials medical group/PAREXEL
state: California
Study officials:
References: