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CompletedNCT06055023Updated Apr 3, 2025

Phase I Clinical Study of ZL-82 Tablets

A Phase 1 interventional study of ZL-82 12.5mg and ZL-82 25mg in Rheumatoid Arthritis (RA) and Inflammatory Bowel Disease - IBD1, sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-03.

Sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Apr 2023, registered Sep 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

ZL-82 is an oral janus kinase (JAK) inhibitor. In vitro biological mass spectrometry identification test proves that ZL-82 can selectively and irreversibly inhibit JAK3. It has obvious safety advantages, with a wide therapeutic window and controllable cardiotoxicity. This is also demonstrated from preliminary GLP-conditions of acute toxicity in SD rats and Beagle dogs. Results of 4-week long-term toxicity in Beagle dogs also support this notion. Therefore, ZL-82 has the potential to treat rheumatoid arthritis. It Used to relieve and heal swelling, pain, stiffness, and limited mobility that may be caused by rheumatoid arthritis.The drug is intended to be used in patients with RA to relieve and heal swelling, pain, stiffness, and limited mobility that may be caused by rheumatoid arthritis.

Pharmacodynamic studies show that ZL-82 has a strong inhibitory effect on JAK3 with IC50 of 2.8 nM, and has no obvious inhibitory effect on JAK1, JAK2 and TYK2. Compared with the similar drug Tofacitinib, its inhibitory effect on JAK3 subtype is 1nM, but its inhibition IC50 for JAK1 subtype and JAK2 subtype are 112nM and 20nM, respectively.and its selectivity is 100-fold and 20-fold, respectively.Also, the selectivity multiples of ZL-82 were 100-fold and 20-fold than tofacitinib , respectively, which indicates that ZL-82 is more selective than the marketed Tofacitinib.This allows ZL-82 to precisely inhibit JAK kinase and block a series of cytokines in the downstream signaling pathway. And show significant effect on rheumatoid arthritis.

The experimental results showed that in DTH and CIA models, 25, 50, 75, and 100 mg/kg of this variety could dose-dependently inhibit joint swelling in mice.

Objectives of Study

Main Purpose:

  1. To evaluate the tolerability, safety and pharmacokinetic characteristics of a single oral dose of ZL-82 tablets in healthy adult subjects;
  2. To explore the effect of eating on the PK of oral ZL-82 tablets in healthy adult subjects;
  3. To evaluate the tolerability, safety and pharmacokinetics of ZL-82 tablets after multiple oral administration in healthy adult subjects.
02

Conditions studied

  • Rheumatoid Arthritis (RA)
  • Inflammatory Bowel Disease - IBD1
03

In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.

This study's enrollment of 69 is close to the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

Chengdu Zenitar Biomedical Technology Co., Ltd is the lead sponsor of 23 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy subjects, regardless of gender, 18 to 45 years old (including 18 and 45 years old)
  • The weighing of male subjects ≥ 50kg, female subjects ≥ 45kg, and a body mass index (BMI) between 19 and 25kg/m2 (including boundary values)
  • The medical history, physical examination, laboratory examination items and various tests and tests related to the trial before enrollment were normal or abnormal without clinical significance, and the clinical research doctor judged that they were qualified.
  • Be able to understand the informed consent form, voluntarily participate in the trial and sign the informed consent form

Exclusion criteria

Exclusion Criteria:

  • Allergic constitution, such as those who are known to be allergic to two or more substances, or those who are known to be allergic to JAK inhibitors or to the excipients contained in the test drug
  • ALT and/or AST>1×ULN, TIB>1×ULN, GGT>1×ULN; Scr>1×ULN
  • Major surgery within the 3 months prior to the trial or planning to undergo surgery during the trial
  • Acute illness within 2 weeks prior to trial
  • Have any serious diseases such as cardiovascular system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumor, mental illness, etc.
  • History of dysphagia or any gastrointestinal disease (or gastrointestinal resection, etc.) affecting drug absorption
  • HIV antibody, Treponema pallidum antibody, hepatitis B surface antigen and hepatitis C antibody test are positive
  • Positive urine drug screen (including morphine, methamphetamine, ketamine, MDMA, THC)
  • Systolic blood pressure>140mmHg or diastolic blood pressure>90mmHg during the screening period;
  • Blood donation or blood loss ≥400mL within 3 months, or blood transfusion; blood donation or blood loss ≥200mL within 1 month;
  • Have special requirements for diet or cannot comply with the unified diet and corresponding regulations of the research center
  • Alcoholics (alcoholism refers to drinking 60-degree white wine ≥10.5L or red wine ≥3.5L per week for more than 5 years), drinking a lot of coffee-containing beverages (more than 8 cups per day, 1 cup = 250ml) or heavy smoking (average > 20 sticks/day);
  • Have used any prescription drugs (JAK inhibitors, etc.) that may have an effect on the test drug within 2 weeks;
  • 4 weeks (28 days) before enrollment, strong inducers of liver metabolic enzymes was limit. ( such as omeprazole, barbiturates, carbamazepine, aminoglutamine, griseofulvin, carbamazepine, Phenytoin, Gluter, Rifampicin, Sulfinpyrazone, Roxithromycin, etc. )
  • Participate in clinical trials of other drugs or medical devices as subjects within 3 months
  • Women who are pregnant or breastfeeding or women of childbearing age who have had unprotected sex with their partner within 14 days before the test;
  • The subjects or their partners are unwilling to use non-drug contraceptive measures (such as total abstinence, condoms, IUDs, ligation, etc.) for contraception during the trial, or the subject and his partner has a pregnancy plan within 6 months of signing the informed consent;
  • Not suitable to participate in the trial according to the judgment of the investigator.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    ZL-82

    1 case，The starting dose，Take the medicine once on D1 ，D1 through 7.

    Drug: ZL-82 12.5mg · Drug: ZL-82 25mg · Drug: ZL-82 50mg · Drug: ZL-82 100mg · Drug: ZL-82 200mg · Drug: ZL-82 300mg · Drug: ZL-82 450mg · Drug: ZL-82 600mg

  • Placebo comparator
    zL-82 placebo group

    1 case,The starting dose,Take the medicine once on D1,D1-7.

    Drug: zL-82 placebo 12.5mg · Drug: ZL-82 placebo 25mg · Drug: ZL-82 placebo 50mg · Drug: ZL-82 placebo 100mg · Drug: ZL-82 placebo 200mg · Drug: ZL-82 placebo 300mg · Drug: ZL-82 placebo 450mg · Drug: ZL-82 placebo 600mg

Interventions

  • DrugZL-82 12.5mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

  • DrugZL-82 25mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

  • DrugZL-82 50mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

  • DrugZL-82 100mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

  • DrugZL-82 200mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

  • DrugZL-82 300mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

  • DrugZL-82 450mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

  • DrugZL-82 600mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

  • DrugzL-82 placebo 12.5mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

  • DrugZL-82 placebo 25mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

  • DrugZL-82 placebo 50mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

  • DrugZL-82 placebo 100mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

  • DrugZL-82 placebo 200mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

  • DrugZL-82 placebo 300mg

    1 case,The starting dose,Take the medicine once on D1,D1-7. Edit

  • DrugZL-82 placebo 450mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

  • DrugZL-82 placebo 600mg

    1 case,The starting dose,Take the medicine once on D1,D1-7.

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK) of ZL-82：Cmax

    Estimation of maximum observed plasma concentration

    Time frame: 24hours

  2. Pharmacokinetics (PK) of ZL-82：Tmax

    Estimation of time to reach Cmax

    Time frame: 24hours

  3. Pharmacokinetics (PK) of ZL-82：AUC0-24h

    Estimation of AUC from time zero to the last measured time point

    Time frame: 24hours

  4. Pharmacokinetics (PK) of ZL-82：AUC0-∞

    Estimation of AUC from time zero extrapolated to infinity

    Time frame: 24hours

  5. Pharmacokinetics (PK) of ZL-82：Vd

    Estimation of apparent volume of distribution

    Time frame: 24hours

  6. Pharmacokinetics (PK) of ZL-82：t1/2

    Estimation of terminal elimination half-life

    Time frame: 24hours

  7. Pharmacokinetics (PK) of ZL-82：CLz/F

    Estimation of clearance when dosed orally

    Time frame: 24hours

  8. Pharmacokinetics (PK) of ZL-82：Vz/F

    Estimation of apparent volume of distribution when dosed orally

    Time frame: 24hours

  9. Pharmacokinetics (PK) of ZL-82：Kel

    Estimation of the elimination rate constant of a drug in the body

    Time frame: 24hours

07

Study locations

1 site
  • Affiliated Hospital of Guizhou Medical University
    Guizhou, GuiYang, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06055023
Lead sponsor
Chengdu Zenitar Biomedical Technology Co., Ltd
Responsible party
Sponsor
First posted
Sep 26, 2023
Start date
Apr 9, 2023
Primary completion
Jan 28, 2024
Completion
Jun 13, 2024
Last update
Apr 3, 2025

Study contacts

Chen Lijuan, doctor
study chair · West China Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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