Phase 1 Study to Evaluate Safety and Pharmacokinetics of FZJ-003 in Healthy Volunteers

NCT04715529 | Completed Phase 1

• 1 other identifier: F0025-101
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and fasting/postprandial pharmacokinetics of FZJ-003, an oral Janus kinase1 (JAK1) inhibitor.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability

  Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; ECG testing). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study.

  up to 72 hours postdose

Secondary Outcomes (3)

• Maximum Plasma Concentration (Cmax)

  up to 72 hours postdose

• Area under the plasma concentration-time curve (AUC)

  up to 72 hours postdose

• Pharmacodynamics (PD) parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers

  up to 24 hours postdose

Study Arms (2)

FZJ-003

EXPERIMENTAL

Drug: FZJ-003

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

FZJ-003 DRUG

Subjects will receive FZJ-003 oral capsules in a dose escalation format.

FZJ-003

Placebo DRUG

Subjects will receive placebo oral capsules (matching FZJ-003) in a dose escalation format .

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent；
• Communicate well with the researcher and be able to complete the research in accordance with the research regulations；
• No plan for pregnancy in the next 6 months and voluntarily take effective contraceptive measures; No plan for sperm or egg donation；
• Healthy male and/or female subjects between the ages of 18 and 50 years ( inclusive)；
• Male body weight≥50.0kg or female body weight≥45.0kg; Body Mass Index (BMI) between 18 to 28 (both inclusive), calculated as weight in kg / height in m2.

You may not qualify if:

• Someone smoking more than 5 pieces per day within the 3 months before the trial；
• Suspected of being allergic to investigational drug or any ingredient in the investigational drug, or people with allergies (multi-drug or food allergies)；
• Having a history of alcohol abuse (14 units of alcohol per week: 1 units = beer 285 mL, or 25 mL of spirits, or 100 mL of wine);
• Blood donation or extensive blood loss ≥400 mL within 3 months before screening, or planning blood donors during the study;
• Urine drug test positive or have a history of drug abuse or drug use in the past 5 years;
• Subjects who were intolerant of high-fat meals (2 boiled eggs, 1 slices of buttered bacon toast, a box of fries, and a glass of whole milk) were applied only to subjects who participated in the postprandial test;
• Taked any drug within 14 days before screening, including prescription drugs, over-the-counter drugs, Chinese herbal medicines and health products (except regular supplementary vitamins);
• Taked any drug that changes liver drug enzyme activity within 28 days before screening, such as CYP3A4 inhibitors or inducers;
• Major changes in diet or exercise habits within 2 weeks before screening or during the period from screening to administration;
• Took a special diet (including dragon fruit, mango, grapefruit, etc.) or strenuous exercise, and other activities that affect drug absorption, distribution, metabolism, excretion and so on within 2 weeks before screening;
• Received or planned to receive any vaccine within 30 days before and after the trial;
• Participated in clinical trials within 3 months before the first administration of the study, or planned to participate in other clinical trials during the study period;
• Having difficulty of swallowing or any history of gastrointestinal diseases that affect drug absorption;
• With low immune function or immunodeficiency, or long-term use of immunosuppressive drugs; or used immunosuppressive drugs within 30 days before screeing;
• Have or have had malignant tumors；

Sponsors & Collaborators

• Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.: lead

Study Sites (1)

the First Bethune Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SAD and MAD: 6 cohorts, 8 subjects take FZJ-003 and 2 subjects take placebo; Food Effect on Phamocokinetics: 14 subjects, crossover designing

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 20, 2021
• Study Start: January 27, 2021
• Primary Completion: July 13, 2022
• Study Completion: July 13, 2022
• Last Updated: March 12, 2025

Record last verified: 2023-05

Locations

CN (1)