A Food Effect Study of JAB-21822 in Healthy Subjects

• Sponsor: Jacobio Pharmaceuticals Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05875493
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Food Effect in Healthy Participants	Drug: JAB-21822; Drug: JAB-21822	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This is an open-label,randomized, 2-cycle,2-period crossover,food effect studyThis is an open-label,randomized, 2-cycle,2-period crossover,food effect study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A-JAB-21822 Dosing in the fasted state followed by fed dosing	Drug: JAB-21822; 2 discrete single doses separated by 7days
Experimental: B-JAB-21822 Dosing in the fed state followed by fasted dosing	Drug: JAB-21822; 2 discrete single doses separated by 7days

Outcome Measures

Primary Outcome Measures

1. Area under plasma Concentration (AUC) 0 to∞ [31days]

   Area under the plasma concentration time curve of JAB-21822

2. Area under plasma Concentration (AUC) 0 to t [31days]

   Area under the plasma concentration time curve of JAB-21822

3. Plasma concentration ( Cmax) [31days]

   Highest observed plasma concentration of JAB-21822

Secondary Outcome Measures

1. Time to achieve Cmax (Tmax) [31days]

   Time of highest observed plasma concentration of JAB-21822

2. Elimination rate constant (λz) [31days]

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

3. Concentration half-life (T1/2) [31days]

   Elimination half-life of unchanged form and its metabolite of JAB-21822

4. Absorption lag-time (Tlag) [31days]

   Elimination lag-time of JAB-21822

5. Apparent volume of distribution (Vz/F) [31days]

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

6. Oral clearance (CL/F) [31days]

   Apparent total body clearance of unchanged form of JAB-21822

7. Number of participants with adverse events (AEs) and serious adverse events(SAEs) [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 [31days]

   Abnormal values of lab parameters

9. Number of subjects with abnormal electrocardiogram (12-lead ECG) [31days]

   Prolongation of the QTc interval

10. Number of subjects with abnormal systolic and diastolic blood pressure [31days]

    Abnormal values in systolic and diastolic blood pressure

11. Number of subjects with abnormal pulse rate [31days]

    Abnormal values in pulse rate

12. Number of subjects with abnormal respiratory rate [31days]

    Abnormal values in respiratory rate

13. Number of subjects with abnormal body temperature [31days]

    Abnormal values of body temperature

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing GoBroad Boren Hospital	Beijing	Beijing	China	100070

Sponsors and Collaborators

• Jacobio Pharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jacobio Pharmaceuticals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05875493
• Other Study ID Numbers: JAB-21822-1009
• First Posted: May 25, 2023
• Last Update Posted: May 25, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 25, 2023