NCT07753902 - Bioequivalence Study of ADC118 Tablets in Healthy Chinese Volunteers Under Fasting Conditions | Crick

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

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Inclusion Criteria: * Healthy adult males and non-pregnant, non-lactating healthy adult females, aged 18 to 55 years (inclusive) at the time of signing the informed consent form. Subjects who exceed 55 years of age during the trial will not be excluded. * Weight: males ≥ 50.0 kg, females ≥ 45.0 kg; body mass index (BMI) \[BMI = weight (kg)/height² (m²)\] between 19.0 and 26.0 kg/m² (inclusive). * Participants (including their partners) are willing to have no pregnancy plan from the screening period until 6 months after the end of the trial, voluntarily use effective contraceptive measures, and have no plans for childbearing or sperm/egg donation. * Fully understand the content of the informed consent form, voluntarily sign it, and voluntarily participate in the trial. * Able to complete the study according to the requirements of the trial protocol. Exclusion Criteria: * Subjects with a history of allergy (allergic to two or more drugs or foods), or known allergy to the investigational product or its excipients. * Subjects with any history of clinically significant disease, or history of cardiovascular, endocrine, neurological, digestive system diseases, or pulmonary, hematological, immunological, psychiatric diseases, and metabolic abnormalities. * Subjects who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the trial, and those who have undergone any surgery that could affect the absorption, distribution, metabolism, or excretion of the drug. * Subjects with abnormalities in physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory tests that are deemed clinically significant by the investigator. * Female participants who are lactating or have a positive pregnancy test during the screening period or during the trial. * Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus (HIV) antibody, or syphilis screening. * Subjects who have taken any other investigational drug or participated in any other medical or drug clinical trial within 3 months prior to screening. * Subjects who have received any vaccination within 1 month prior to screening. * Subjects who have donated more than 400 mL of blood or experienced significant blood loss (\>400 mL) within 3 months prior to screening, or who plan to donate blood during the trial or within one month after the end of the trial. * Subjects who have a smoking habit (average of ≥5 cigarettes per day) within 3 months prior to screening, or who are unable to abstain from using any tobacco products during the trial. * Subjects who have consumed more than 14 units of alcohol per week within 6 months prior to screening (1 unit of alcohol = 360 mL of beer, or 45 mL of spirits with 40% alcohol, or 150 mL of wine), or who are unable to abstain from alcohol during the trial, or who have a positive alcohol screening test. * Subjects with a positive drug abuse screening test, or a history of drug abuse, or who have used illicit drugs within 3 months prior to screening. * Subjects who have taken any prescription drugs, over-the-counter medications, health supplements, or herbal medicines within 14 days prior to screening. * Subjects who develop any new illness or use any new medication (including prescription drugs, over-the-counter medications, health supplements, or herbal medicines) during the period from screening to admission on Day -1. * Subjects with special dietary requirements who are unable to comply with the standardized diet. * Subjects with difficulty in blood collection or a history of needle phobia or vasovagal syncope associated with blood draws. * Subjects who are unable to complete the trial due to other reasons, or who are deemed unsuitable for enrollment by the investigator.

Outcomes

Primary Outcomes

PK Parameter: Cmax

Cmax is defined as the maximum observed plasma concentration of the drug, obtained directly from the concentration-time data, following a single oral dose of the test or reference product under fasting conditions.

Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period

PK Parameter: AUC0-t

AUC0-t is defined as the area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule.

Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period

PK Parameter: AUC0-∞

AUC0-∞ is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity, calculated as AUC0-t + Clast/λz, where Clast is the last measurable plasma concentration and λz is the terminal elimination rate constant.

Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period

Secondary Outcomes

PK Parameter: Tmax

Tmax is defined as the time to reach the maximum observed plasma concentration (Cmax)

Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period

PK Parameter: AUC0-24h

AUC0-24h is defined as the area under the plasma concentration-time curve from time zero to 24 hours post-dose.

Time frame: Day 1 (pre-dose) through Day 2 (24 hours post-dose) of each treatment period

PK Parameter: C24h

C24h is defined as the plasma drug concentration sampled at 24 hours post-dose.

Time frame: 24 hours post-dose on Day 2 of each treatment period

PK Parameter: AUC_%Extrap

AUC\_%Extrap is defined as the percentage of AUC0-∞ that is due to extrapolation from the time of the last measurable concentration (Tlast) to infinity, calculated as \[(AUC0-∞ - AUC0-t) / AUC0-∞\] × 100%.

Time frame: Day 1 through Day 6 of each treatment period

PK Parameter: t1/2

t1/2 is defined as the plasma elimination half-life, calculated as ln(2)/λz. λz is the terminal elimination rate constant, determined by linear regression of the log-transformed plasma concentration versus time curve; the negative value of the slope represents λz.

Time frame: Day 1 through Day 6 of each treatment period

Safety: Adverse Events

Frequency, causality, severity, and expectedness of treatment-emergent adverse events (TEAEs), including Adverse Drug Reactions (ADRs), Grade ≥3 AEs, Serious Adverse Events (SAEs), Serious Adverse Drug Reactions (SADRs), and AEs leading to treatment discontinuation or early withdrawal from the trial.

Time frame: From signing of informed consent through study completion, up to approximately 10 weeks

Vital sign: Systolic blood pressure and diastolic blood pressure

Changes from baseline in systolic blood pressure and diastolic blood pressure.