Clinical trial NCT05875493: A Food Effect Study of JAB-21822 in Healthy Subjects
Official title: A Phase I, Single-center, Randomized, Open-label, 2-cycle,2-period Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of JAB-21822 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Food Effect in Healthy Participants
Lead sponsor: Allist Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is an open-label,randomized, 2-cycle,2-period crossover,food effect study
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of JAB-21822 following single dose administration with and without a meal

Detailed description: This is an open-label,randomized, 2-cycle,2-period crossover,food effect study. On Day 1 of each period, subjects will receive a single oral dose of JAB-21822 administered either under fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for JAB-21822 will be collected predose and postdose. There will be a washout period between doses.

Eligibility criteria: Inclusion Criteria:

* Male or female , between 18 and 45 years of age
* Bodyweight (male) ≥50kg, Bodyweight (Female) ≥45kg；BMI within the range of 19 to 25 kg/m2, inclusive
* No clinically significant abnormalities identified in the judgement of investigator at screening
* Written informed consent prior to any study specific procedures

Exclusion Criteria:

* History of clinically significant disease or disorder
* History of interstitial pneumonia, pulmonary fibrosis, and other interstitial lung diseases
* History of dysphagia or any gastrointestinal disease that would potentially alter absorption of drug
* COVID-19 positive at screening or baseline
* Allergic to JAB-21822 and any of the tablet's ingredients, history of hypersensitivity or allergy to drug or food
* Received surgical procedure within 3 months at screening
* Blood donation within the 3 months or planing to donate during the study
* Participated in another clinical trial of biological agents within 6 months at screening, or any other clinical trial within 3 months at screening
* History of drug abuse or positive urine drug test
* Received the vaccine within 3 months at screening or planning to receive during the study
* Overtake of achole,tea and coffee prior to first dosing and unable to control during the study
* Special dietary requirements or unable to control during the study
* HIV, HBV, HCV, and syphilis positive
* Pregnant or breast-feeding women or positive of blood pregnancy test
* Subjects who are considered to be unacceptable in this study under the opinion of the investigator

Primary outcomes:
measure: Area under plasma concentration (AUC) 0 to∞
timeFrame: 31days
measure: Area under plasma concentration (AUC) 0 to t
timeFrame: 31days
measure: Plasma concentration ( Cmax)
timeFrame: 31days
Secondary outcomes:
measure: Time to achieve Cmax (Tmax)
timeFrame: 31days
measure: Elimination rate constant (λz)
timeFrame: 31days
measure: Concentration half-life (T1/2)
timeFrame: 31days
measure: Absorption lag-time (Tlag)
timeFrame: 31days
measure: Apparent volume of distribution (Vz/F)
timeFrame: 31days
measure: Apparent clearance (CL/F)
timeFrame: 31days
measure: Number of participants with adverse events (AEs) and serious adverse events(SAEs)
timeFrame: 31days
measure: Number of subjects with abnormal lab parameters
timeFrame: 31days
measure: Number of subjects with abnormal electrocardiogram (12-lead ECG)
timeFrame: 31days
measure: Number of subjects with abnormal systolic and diastolic blood pressure
timeFrame: 31days
measure: Number of subjects with abnormal pulse rate
timeFrame: 31days
measure: Number of subjects with abnormal respiratory rate
timeFrame: 31days
measure: Number of subjects with abnormal body temperature
timeFrame: 31days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing GoBroad Boren Hospital
state: Beijing
Study officials:
affiliation: Beijing Gaobo Boren Hospital
name: He Qing B.Pharm
role: PRINCIPAL_INVESTIGATOR
References: