Rheumatoid Arthritis (RA)Phase 1NCT06055023

Phase I Clinical Study of ZL-82 Tablets

A Phase 1 study testing ZL-82 12.5mg, ZL-82 25mg and ZL-82 50mg in people with Rheumatoid Arthritis (RA) and Inflammatory Bowel Disease - IBD1, run by Chengdu Zenitar Biomedical Technology Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Rheumatoid Arthritis (RA), Inflammatory Bowel Disease - IBD1
What is being tested?: ZL-82 12.5mg, ZL-82 25mg and ZL-82 50mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 69 participants
Where: 1 siteChina
Study dates: 9 Apr 2023to 13 Jun 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 18Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Affiliated Hospital of Guizhou Medical University
Guizhou, GuiYang

Other trials in China

About this study

Official title: Phase I Clinical Study on the Tolerability, Safety and Pharmacokinetics of Single-dose Dose Escalation and Multiple-dose Oral ZL-82 Tablets in Healthy Adult Subjects

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:

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

Conditions: Rheumatoid Arthritis (RA), Inflammatory Bowel Disease - IBD1
Being tested: ZL-82 12.5mg, ZL-82 25mg, ZL-82 50mg, ZL-82 100mg, ZL-82 200mg
Medical subject headings: Arthritis, Rheumatoid, Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZL-82 12.5mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.
ZL-82 25mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.
ZL-82 50mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.
ZL-82 100mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.
ZL-82 200mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.
ZL-82 300mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.
ZL-82 450mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.
ZL-82 600mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.
zL-82 placebo 12.5mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.
ZL-82 placebo 25mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.
ZL-82 placebo 50mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.
ZL-82 placebo 100mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.
ZL-82 placebo 200mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.
ZL-82 placebo 300mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7. Edit
ZL-82 placebo 450mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.
ZL-82 placebo 600mgDrug
1 case,The starting dose,Take the medicine once on D1,D1-7.

Study groups in NCT06055023
Study group	Role	What they receive
ZL-82	Experimental	1 case，The starting dose，Take the medicine once on D1 ，D1 through 7. Receives: 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
zL-82 placebo group	Placebo comparator	1 case,The starting dose,Take the medicine once on D1,D1-7. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK) of ZL-82：Cmax
Estimation of maximum observed plasma concentration
Measured: 24hours
Pharmacokinetics (PK) of ZL-82：Tmax
Estimation of time to reach Cmax
Measured: 24hours
Pharmacokinetics (PK) of ZL-82：AUC0-24h
Estimation of AUC from time zero to the last measured time point
Measured: 24hours
Pharmacokinetics (PK) of ZL-82：AUC0-∞
Estimation of AUC from time zero extrapolated to infinity
Measured: 24hours
Pharmacokinetics (PK) of ZL-82：Vd
Estimation of apparent volume of distribution
Measured: 24hours
Pharmacokinetics (PK) of ZL-82：t1/2
Estimation of terminal elimination half-life
Measured: 24hours
Pharmacokinetics (PK) of ZL-82：CLz/F
Estimation of clearance when dosed orally
Measured: 24hours
Pharmacokinetics (PK) of ZL-82：Vz/F
Estimation of apparent volume of distribution when dosed orally
Measured: 24hours
Pharmacokinetics (PK) of ZL-82：Kel
Estimation of the elimination rate constant of a drug in the body
Measured: 24hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Apr 202313 Jun 2024

First posted26 Sep 2023
Study start9 Apr 2023
Primary completion28 Jan 2024
Study completion13 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
More trials run by Chengdu Zenitar Biomedical Technology Co., LtdThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06055023
Sponsor's protocol ID: H-ZL82-PI-I
Status last verified: Mar 2025
First submitted: 19 Sep 2023
Last updated: 3 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
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Recruiting
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The Impact of Rheumatoid Arthritis Treatments on the Modulation of Extracellular Vesicles and Other Biomarkers Involved in the Development of Lung Cancer
Rheumatoid Arthritis (RA), Lung Neoplasms
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All Rheumatoid Arthritis (RA) trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Study on the Tolerability, Safety and Pharmacokinetics of Single-dose Dose Escalation and Multiple-dose Oral ZL-82 Tablets in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT06055023
Acronym / sponsor ID: H-ZL82-PI-I
Conditions: Rheumatoid Arthritis (RA), Inflammatory Bowel Disease - IBD1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Chengdu Zenitar Biomedical Technology Co., LtdIndustry (pharma, biotech, devices)
Study start: 9 Apr 2023 (actual)
Primary completion: 28 Jan 2024 (actual)
Study completion: 13 Jun 2024 (actual)
First posted: 26 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ZL-82	Experimental	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 600mg1 case，The starting dose，Take the medicine once on D1 ，D1 through 7.
zL-82 placebo group	Placebo comparator	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 600mg1 case,The starting dose,Take the medicine once on D1,D1-7.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (18 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ZL-82 12.5mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	ZL-82
ZL-82 25mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	ZL-82
ZL-82 50mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	ZL-82
ZL-82 100mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	ZL-82
ZL-82 200mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	ZL-82
ZL-82 300mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	ZL-82
ZL-82 450mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	ZL-82
ZL-82 600mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	ZL-82
zL-82 placebo 12.5mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	zL-82 placebo group
ZL-82 placebo 25mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	zL-82 placebo group
ZL-82 placebo 50mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	zL-82 placebo group
ZL-82 placebo 100mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	zL-82 placebo group
ZL-82 placebo 200mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	zL-82 placebo group
ZL-82 placebo 300mg1 case,The starting dose,Take the medicine once on D1,D1-7. Edit	Drug	zL-82 placebo group
ZL-82 placebo 450mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	zL-82 placebo group
ZL-82 placebo 600mg1 case,The starting dose,Take the medicine once on D1,D1-7.	Drug	zL-82 placebo group

Primary outcome

Pharmacokinetics (PK) of ZL-82：Cmax
Time frame: 24hours
Estimation of maximum observed plasma concentration
Pharmacokinetics (PK) of ZL-82：Tmax
Time frame: 24hours
Estimation of time to reach Cmax
Pharmacokinetics (PK) of ZL-82：AUC0-24h
Time frame: 24hours
Estimation of AUC from time zero to the last measured time point
Pharmacokinetics (PK) of ZL-82：AUC0-∞
Time frame: 24hours
Estimation of AUC from time zero extrapolated to infinity
Pharmacokinetics (PK) of ZL-82：Vd
Time frame: 24hours
Estimation of apparent volume of distribution
Pharmacokinetics (PK) of ZL-82：t1/2
Time frame: 24hours
Estimation of terminal elimination half-life
Pharmacokinetics (PK) of ZL-82：CLz/F
Time frame: 24hours
Estimation of clearance when dosed orally
Pharmacokinetics (PK) of ZL-82：Vz/F
Time frame: 24hours
Estimation of apparent volume of distribution when dosed orally
Pharmacokinetics (PK) of ZL-82：Kel
Time frame: 24hours
Estimation of the elimination rate constant of a drug in the body

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chen Lijuan, doctor study chair

West China Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK) of ZL-82：Cmax (time frame: 24hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06055023.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.