Skip to main content
OpenTrials
Completed

NCT Number: NCT05875493

A Food Effect Study 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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing GoBroad Boren Hospital

Beijing, Beijing Municipality, 100070, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JAB-21822

Drug

2 discrete single doses

Primary outcomes

  1. Area under plasma concentration (AUC) 0 to∞

    Time frame: 31days

    Area under the plasma concentration time curve of JAB-21822

  2. Area under plasma concentration (AUC) 0 to t

    Time frame: 31days

    Area under the plasma concentration time curve of JAB-21822

  3. Plasma concentration ( Cmax)

    Time frame: 31days

    Highest observed plasma concentration of JAB-21822

Secondary outcomes

  1. Time to achieve Cmax (Tmax)

    Time frame: 31days

    Time of highest observed plasma concentration of JAB-21822

  2. Elimination rate constant (λz)

    Time frame: 31days

    Elimination rate constant based on the terminal phase of unchanged form of JAB-21822

  3. Concentration half-life (T1/2)

    Time frame: 31days

    Elimination half-life of unchanged form of JAB-21822

  4. Absorption lag-time (Tlag)

    Time frame: 31days

    Elimination lag-time of JAB-21822

  5. Apparent volume of distribution (Vz/F)

    Time frame: 31days

    Apparent volume of distribution based on the terminal phase of unchanged form of JAB-21822

  6. Apparent clearance (CL/F)

    Time frame: 31days

    Apparent total body clearance of unchanged form of JAB-21822

  7. Number of participants with adverse events (AEs) and serious adverse events(SAEs)

    Time frame: 31days

    Incidence,duration and severity of adverse events and serious adverse events according to NCI-CTCAE v5.0

  8. Number of subjects with abnormal lab parameters

    Time frame: 31days

    Abnormal values of lab parameters

  9. Number of subjects with abnormal electrocardiogram (12-lead ECG)

    Time frame: 31days

    Prolongation of the QTc interval

  10. Number of subjects with abnormal systolic and diastolic blood pressure

    Time frame: 31days

    Abnormal values in systolic and diastolic blood pressure

  11. Number of subjects with abnormal pulse rate

    Time frame: 31days

    Abnormal values in pulse rate

  12. Number of subjects with abnormal respiratory rate

    Time frame: 31days

    Abnormal values in respiratory rate

  13. Number of subjects with abnormal body temperature

    Time frame: 31days

    Abnormal values of body temperature

Sponsors and collaborators

Lead sponsor

Allist Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 25, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.