A Food Effect Study of JAB-21822 in Healthy Subjects

Food Effect in Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05875493
• Other study ID #: JAB-21822-1009
• Status: Completed
• Phase: Phase 1
• Start date: May 12, 2023
• Est. completion date: June 14, 2023

Study information

• Verified date: January 2024
• Source: Jacobio Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 14, 2023
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Effect in Healthy Participants

Intervention

Drug:
• JAB-21822
2 discrete single doses
• JAB-21822
2 discrete single doses

Locations

Country	Name	City	State
China	Beijing GoBroad Boren Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jacobio Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under plasma concentration (AUC) 0 to8	Area under the plasma concentration time curve of JAB-21822	31days
Primary	Area under plasma concentration (AUC) 0 to t	Area under the plasma concentration time curve of JAB-21822	31days
Primary	Plasma concentration ( Cmax)	Highest observed plasma concentration of JAB-21822	31days
Secondary	Time to achieve Cmax (Tmax)	Time of highest observed plasma concentration of JAB-21822	31days
Secondary	Elimination rate constant (?z)	Elimination rate constant based on the terminal phase of unchanged form of JAB-21822	31days
Secondary	Concentration half-life (T1/2)	Elimination half-life of unchanged form of JAB-21822	31days
Secondary	Absorption lag-time (Tlag)	Elimination lag-time of JAB-21822	31days
Secondary	Apparent volume of distribution (Vz/F)	Apparent volume of distribution based on the terminal phase of unchanged form of JAB-21822	31days
Secondary	Apparent clearance (CL/F)	Apparent total body clearance of unchanged form of JAB-21822	31days
Secondary	Number of participants with adverse events (AEs) and serious adverse events(SAEs)	Incidence,duration and severity of adverse events and serious adverse events according to NCI-CTCAE v5.0	31days
Secondary	Number of subjects with abnormal lab parameters	Abnormal values of lab parameters	31days
Secondary	Number of subjects with abnormal electrocardiogram (12-lead ECG)	Prolongation of the QTc interval	31days
Secondary	Number of subjects with abnormal systolic and diastolic blood pressure	Abnormal values in systolic and diastolic blood pressure	31days
Secondary	Number of subjects with abnormal pulse rate	Abnormal values in pulse rate	31days
Secondary	Number of subjects with abnormal respiratory rate	Abnormal values in respiratory rate	31days
Secondary	Number of subjects with abnormal body temperature	Abnormal values of body temperature	31days