Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects

IlDong Pharmaceutical

Status and phase: Terminated; Phase 1

Conditions: Healthy Participants

Treatments: Drug: ID119031166M; Drug: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05604287

ID119031166M-NASH-101

Details and patient eligibility

About

This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.

Full 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).

Enrollment: 67 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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67 participants in 4 patient groups, including a placebo group

SAD: ID119031166M

Experimental group

Treatment:

Drug: ID119031166M

MAD: ID119031166M

Experimental group

Treatment:

Drug: ID119031166M

SAD: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

MAD: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo