A Food Effect Study of JAB-21822 in Healthy Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Food Effect in Healthy Participants
• Intervention / Treatment: Drug: JAB-21822

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jacobio Pharmaceuticals; Phone Number: 86 10 56315466; Email: clinicaltrials@jacobiopharma.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing GoBroad Boren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A-JAB-21822; Dosing in the fasted state followed by fed dosing	Drug: JAB-21822; 2 discrete single doses
Experimental: B-JAB-21822; Dosing in the fed state followed by fasted dosing	Drug: JAB-21822; 2 discrete single doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration ( Cmax)	Highest observed plasma concentration of JAB-21822	31days
Area under plasma concentration (AUC) 0 to∞	Area under the plasma concentration time curve of JAB-21822	31days
Area under plasma concentration (AUC) 0 to t	Area under the plasma concentration time curve of JAB-21822	31days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve Cmax (Tmax)	Time of highest observed plasma concentration of JAB-21822	31days
Absorption lag-time (Tlag)	Elimination lag-time of JAB-21822	31days
Apparent volume of distribution (Vz/F)	Apparent volume of distribution based on the terminal phase of unchanged form of JAB-21822	31days
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
Number of subjects with abnormal lab parameters	Abnormal values of lab parameters	31days
Number of subjects with abnormal electrocardiogram (12-lead ECG)	Prolongation of the QTc interval	31days
Number of subjects with abnormal systolic and diastolic blood pressure	Abnormal values in systolic and diastolic blood pressure	31days
Number of subjects with abnormal pulse rate	Abnormal values in pulse rate	31days
Number of subjects with abnormal respiratory rate	Abnormal values in respiratory rate	31days
Number of subjects with abnormal body temperature	Abnormal values of body temperature	31days
Elimination rate constant (λz)	Elimination rate constant based on the terminal phase of unchanged form of JAB-21822	31days
Concentration half-life (T1/2)	Elimination half-life of unchanged form of JAB-21822	31days
Apparent clearance (CL/F)	Apparent total body clearance of unchanged form of JAB-21822	31days

Collaborators and Investigators

• Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): June 14, 2023

Study Registration Dates

• First Submitted: April 23, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: JAB-21822-1009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No