Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of OPK-88006 in Healthy and Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- SAD - OPK-88006 maximum plasma concentration (Cmax)
研究概览
简要总结
Two-part Phase 1/2 study of OPK-88006, including an open-label SAD phase in healthy participants and a double-blind, randomized, placebo-controlled MAD phase in participants with presumed MASH, to evaluate safety, PK, and MASH related pharmacodynamic changes compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part A (SAD)
- •Inclusion Criteria:
- •Adults aged 18-65 years.
- •BMI ≥27 and ≤35 kg/m².
- •Good general health per investigator assessment.
- •Willing to comply with contraception, trial procedures, and stable diet/exercise.
排除标准
- •Significant uncontrolled medical or psychiatric history.
- •History of pancreatitis, cancer (within 5 years), or substance misuse.
- •Clinically significant abnormal labs (e.g., liver enzymes, low platelets) or ECG findings.
- •Recent use of prohibited medications (GLP-1 agonists, anti-obesity drugs).
- •Pregnant, lactating, or planning pregnancy.
- •Part B (MAD)
- •Inclusion Criteria:
- •Adults aged 18-75 years.
- •Presumed MASH (defined by metabolic risk factors and specific liver tests).
- •BMI ≥27 and ≤40 kg/m² with stable weight.
- •Willing to comply with contraception, trial procedures, and stable diet/exercise.
- •Exclusion Criteria:
- •Significant uncontrolled medical or psychiatric history.
- •History of other liver diseases, cirrhosis, or hepatic decompensation.
- •History of pancreatitis, cancer (within 5 years), or substance misuse.
- •Clinically significant abnormal labs (e.g., elevated liver enzymes, HbA1c ≥9.5%) or ECG findings.
- •Recent use of prohibited medications (GLP-1 agonists, anti-obesity drugs).
- •Pregnant, lactating, or planning pregnancy.
研究组 & 干预措施
SAD - Cohort 1 OPK-88006
干预措施: OPK-88006 (Drug)
SAD - Cohort 3 OPK-88006
干预措施: OPK-88006 (Drug)
SAD - Cohort 2 OPK-88006
干预措施: OPK-88006 (Drug)
MAD - OPK-88006/Placebo
干预措施: OPK-88006 (Drug)
MAD - OPK-88006/Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
SAD - OPK-88006 maximum plasma concentration (Cmax)
时间窗: 2 hours to 1 week
To assess Cmax of OPK-88006 after a single dose
SAD - OPK-88006 Time to peak (Tmax)
时间窗: 2 hours to 1 week
To assess Tmax of OPK-88006 after a single dose
SAD - OPK-88006 Elimination half-life (T1/2)
时间窗: 10 hours to 200 hours
To assess T1/2 of OPK-88006 after a single dose
SAD - Frequency of treatment emergent adverse events (TEAE)
时间窗: Up to 2 weeks
TEAEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
MAD - Frequency of treatment emergent adverse events (TEAE)
时间窗: Up to 20 weeks
TEAEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
MAD - Change in body weight
时间窗: Up to 17 weeks
Change from baseline in body weight (measured in kilograms) during the drug administration.
MAD - Change in fasting lipids
时间窗: Up to 17 weeks
Change from baseline in fasting lipid profile parameters
MAD - Change in liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
时间窗: Up to 17 weeks
Change from baseline in ALT and AST
MAD - Change in liver stiffness with Vibration-controlled Transient Elastography (VCTE)
时间窗: Up to 17 weeks
Change from baseline measured by VCTE
MAD - Change in fibrosis markers measured by Enhanced Liver Fibrosis (ELF) score
时间窗: Up to 17 weeks
Change from baseline in ELF score
MAD - Change in hepatic fat measured by MRI-PDFF
时间窗: Up to 17 weeks
Change from baseline in hepatic fat
次要结局
未报告次要终点