A Food Effect Study of JAB-21822 in Healthy Subjects

NCT05875493 | Completed Phase 1

• 1 other identifier: JAB-21822-1009
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Food Effect in Healthy Participants

Outcome Measures

Primary Outcomes (3)

• 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

• Plasma concentration ( Cmax)

  Highest observed plasma concentration of JAB-21822

  31days

Secondary Outcomes (13)

• Time to achieve Cmax (Tmax)

  31days

• Elimination rate constant (λz)

  31days

• Concentration half-life (T1/2)

  31days

• Absorption lag-time (Tlag)

  31days

• Apparent volume of distribution (Vz/F)

  31days

Study Arms (2)

A-JAB-21822

EXPERIMENTAL

Dosing in the fasted state followed by fed dosing

Drug: JAB-21822

B-JAB-21822

EXPERIMENTAL

Dosing in the fed state followed by fasted dosing

Drug: JAB-21822

Interventions

JAB-21822 DRUG

2 discrete single doses

A-JAB-21822

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allist Pharmaceuticals, Inc.: lead

Study Sites (1)

Beijing GoBroad Boren Hospital

Beijing, Beijing Municipality, 100070, China

Location

Study Officials

• He Qing B.Pharm

  Beijing Gaobo Boren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label,randomized, 2-cycle,2-period crossover,food effect study

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 25, 2023
• Study Start: May 12, 2023
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: April 4, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)