A Phase I Clinical Study of Flonoltinib Maleate Tablets in Healthy Subjects

NCT06387966 | Completed Phase 1 DMC

• 1 other identifier: H-FNTN-PI-Ia
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the safety , tolerability and pharmacokinetics of Flonoltinib Maleate tablets in a single increasing dose oral administered to healthy adult Chinese subjects.Subjects will divide into experimental group and placebo group, conduct single oral administration safety and tolerability test group by group.

Conditions

Heathly Subjects

Outcome Measures

Primary Outcomes (9)

• Tmax

  time to peak

  Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration

• Cmax

  maximum concentration

  Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration

• t1/2

  Terminal phase elimination half-life

  Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration

• CL/F

  Apparent clearance rate

  Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration

• AUC0-t

  Area under the blood concentration-time curve from 0 o 'clock to the last measurable concentration at collection time t

  Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration

• AUC0-∞

  The area under the blood drug concentration-time curve from 0 to infinity time

  Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration

• Vz/F

  apparent volume of distribution

  Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration

• Ae0-144hours and Ae%

  The pharmacokinetic statistical parameters of urine are the cumulative excretion (Ae0-144hours) and excretion rate (Ae%) of prototype drugs and major metabolites in urine，that is collected from the 50 mg and 150mg dose groups.

  Day1 Within 2hours before administration and 0~4 hours, 4~8 hours, 8~12 hours, 12~24 hours, 24~36 hours, 36~48 hours, 48~72 hours, 72~96hours, 96~120 hours, 120~144 hours after administration

• Ae0-144hours and Ae%

  The statistical parameters of fecal pharmacokinetics are the cumulative excretion of prototype drugs and major metabolites in feces (Ae0-144hours) and excretion rate (Ae%) ,that is collected from the 50 mg and 150mg dose groups

  1 blank fecal sample before administration and after administration: 0~24 hours, 24~48 hours,48~72 hours, 72~96hours, 96~120 hours, 120~144 h ours

Secondary Outcomes (1)

• security indicators

  According to the experimental schedule D-14-D7 or early termination

Study Arms (2)

Flonoltinib Maleate Tablets treament group

EXPERIMENTAL

Subjects in this group will take Flonoltinib Maleate Tablets

Drug: Flonoltinib Maleate Tablets

placebo group

PLACEBO COMPARATOR

Subjects in this group will take Flonoltinib Maleate Tablets placebo

Drug: Flonoltinib Maleate Tablets placebo

Interventions

Flonoltinib Maleate Tablets DRUG

Day 1 will be used for drug administration, and Day 1\~Day 7 will be used for experimental data collection.

Also known as: 25mg Flonoltinib Maleate Tablets, 50mg Flonoltinib Maleate Tablets, 100mg Flonoltinib Maleate Tablets, 150mg Flonoltinib Maleate Tablets, 200mg Flonoltinib Maleate Tablets

Flonoltinib Maleate Tablets treament group

Flonoltinib Maleate Tablets placebo DRUG

Day 1 will be used for drug administration, and Day 1\~Day 7 will be used for experimental data collection.

Also known as: 25mg Flonoltinib Maleate Tablets placebo, 50mg Flonoltinib Maleate Tablets placebo, 100mg Flonoltinib Maleate Tablets placebo, 150mg Flonoltinib Maleate Tablets placebo, 200mg Flonoltinib Maleate Tablets placebo

placebo group

Eligibility Criteria

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

You may qualify if:

• Age and gender: 18 to 45 years old (including 18 and 45 years old), no gender limit;
• The weight of male subjects is ≥50.0 kg, the weight of female subjects is ≥45.0 kg, and the body mass index (BMI) is between 19.0 and 25.0 kg/m2 (including the boundary value);
• Those who fully understand the trial content, trial drugs, trial process, etc., can communicate well with the researchers, are willing to comply with the research regulations, voluntarily participate in the trial and sign the informed consent form.

You may not qualify if:

• Those with a history of severe allergies (such as angioedema and anaphylactic shock), allergies (such as allergies to pollen, two or more drugs/foods), or those with Those who are judged by the researcher to have a clinically significant history of food or drug allergies or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.); or those who are known to be allergic to JAK inhibitors or to excipients contained in the trial drug ;
• Pre-selection physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (including: blood routine, blood biochemistry, urine routine, blood pregnancy (females only), infectious disease screening, antinuclear antibodies, coagulation function , tuberculosis antibodies, chest anteroposterior X-ray examination, abdominal color ultrasound) results are abnormal and clinically significant;
• QTcF \> 440 ms for males and \> 460 ms for females on ECG during the screening period;
• Those who have undergone major surgical operations within 3 months before screening or plan to undergo surgery during the trial;
• Those who suffer from acute diseases within 2 weeks before screening; those who have clinically significant infections (such as upper respiratory tract infection, nasopharyngitis, urinary system infection, etc.) within 3 months before screening; those who have any symptoms within 7 days before screening Those with evidence of infection; those with a history of herpes simplex infection or recurrent (\>1) herpes zoster or disseminated herpes zoster.
• Have any history of serious clinical diseases or diseases or conditions that the researcher believes may affect the test results, including but not limited to the circulatory system, endocrine system, nervous system, digestive system, urinary system or History of blood, immune, psychiatric and metabolic diseases;
• Those with a history of dysphagia or any gastrointestinal system disease (or gastrointestinal resection, etc.) that affects drug absorption;
• Those with irregular bowel movements and habitual constipation or diarrhea;
• Those with a history of lipid metabolism defects, such as: familial hyperlipidemia, lipoid nephropathy, or patients with acute pancreatitis accompanied by hyperlipidemia, etc.;
• Those whose urine is positive for multiple combined drug tests (including morphine, methamphetamine, ketamine, methylenedioxyamphetamine, and tetrahydrocannabinolic acid);
• Those who have a history of drug abuse or drug dependence;
• Those who have been vaccinated within 8 weeks before screening, or plan to be vaccinated during the study or within 8 weeks after the administration of study drugs;
• Those who have donated blood or lost ≥400 mL of blood or received blood transfusions within 3 months before screening; or those who have donated blood or blood components within 1 month after the planned trial ends;
• Those who have special requirements for diet or cannot comply with the unified diet and corresponding regulations of the research center;
• Those who smoke more than 3 cigarettes/day or the same amount of tobacco within 3 months before screening; or drink ≥14 units of alcohol per week (1 unit is equal to 17.5mL or 14g of pure alcohol, Approximately equal to 35mL of 50° liquor or 350mL of 5° beer); or those who do not agree to abstain from smoking or drinking during the trial; or those whose alcohol breath test results are positive;

Sponsors & Collaborators

• Chengdu Zenitar Biomedical Technology Co., Ltd: lead

Study Sites (1)

Chengdu Xinhua Hospital

Chengdu, Sichuan, 610000, China

Location

Study Officials

• Xiaolan Yong, bachelor

  Chengdu Xinhua Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: April 29, 2024
• Study Start: March 18, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)