Rheumatoid Arthritis (RA)Phase 1NCT07266207
Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetic, and Food Effects of ARD-885 Film-coated Tablets in Healthy Chinese Subjects and Patients With Rheumatoid Arthritis
A Phase 1 study testing ARD-885 Tablets in people with Rheumatoid Arthritis (RA), run by Artivila (Shenzhen) Innovation Center, Ltd at 1 site in China.
Trial summary
The proposed study is a randomized, double-blind, placebo-controlled single and multiple ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetic, and food effects of ARD-885 Film-coated Tablets in healthy subjects.The entire study includes 3 parts: a single ascending dose study, a multiple… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- ARD-885 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2024to 18 Aug 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects:
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 55. Male and female patients with rheumatoid arthritis between the ages of 18 and 70.
- An informed consent document signed and dated by the subject. Subjects must be willing to understand and comply with all research procedures and restrictions and be able to communicate effectively with investigators.
- A minimum body weight of 50 kg for males and 45 kg for females, with a body mass index of 18 to 28 kg/m2 for healthy subjects and 18 to 35 kg/m2 for patients with RA.
- Subject (including partner) agrees to use at least one effective contraceptive method during sexual activity with partner from screening until 3 months after dosing agrees not to participate in sperm or egg donation during the study period until 3 months after the last dosing. See Section 8.1 for specific contraceptive methods.
Who cannot join
- Known or suspected allergy to any component of ARD-885 Film-coated Tablets, or individuals with a hypersensitivity to allergies (multiple drug and food allergies), as determined by the investigator, and deemed unsuitable for inclusion.
- Lactating women; Women of reproductive age with menstrual disorders within 90 days before administration; Women of childbearing age who have had unprotected sexual intercourse with an opposite-sex partner in the 28 days before administration. Female subjects who are lactating or have a positive serum pregnancy result during the screening period or during the trial.
- Participated in any drug clinical trial within 90 days before administration, or the administration date of this study is still within the safety washout period specified in the previous drug clinical trial.
- Non-physiological blood loss ≥ 200 ml within 60 days before administration (including trauma, blood collection, blood donation); Or plan to donate blood during the trial or within 30 days of administration.
- Had a major disease that investigators considered clinically significant within 90 days before first administration; Have any active malignancy or history of malignancy in the 5 years prior to screening, with the exception of treated and considered cured skin squamous or basal cell carcinoma, cervical carcinoma in situ, or breast ductal carcinoma in situ.
- Had major surgery within 60 days of administration, or had any surgery within 28 days of administration.
Show all 19Show fewer
- Infectious diseases such like fever and so on within 28 days before administration.
- Previous use of any of the drugs or treatments listed in protocol.
- Received vaccine or live attenuated vaccine within 1 month before administration, or who plan to receive the vaccine during the trial period.
- Those who smoked more than 5 pieces of tobacco or equivalent daily in the 3 months before screening, or drank ≥ 14 units of alcohol per week; Or disagree with the prohibition of smoking or alcohol during the trial; Or positive alcohol serum test during screening or baseline (Day-1).
- Those who test positive for urine drugs or have a history of drug abuse or use of drugs in the past five years.
- +Positive for Treponema pallidum antibodies, hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibodies or human immunodeficiency virus antibodies.
- Those who is diagnosed as tuberculosis or have a history of non-tuberculous mycobacterial infections
- Have a serious disease of the blood system or any disease that can cause hemolysis or instability of red blood cells, such as malaria, hemolytic anemia, etc..
- At the time of screening, clinically significant gastrointestinal, liver or kidney abnormalities known abnormal which likely to affect drug intake, transport, absorption, distribution, metabolism or excretion.
- Ingested any food or beverage containing caffein, or other xanthine-rich food or food that can induce or inhibit liver metabolic enzymes and beverages made from it within 48 hours before taking the study drug, or food or beverages containing alcohol, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.
- Those who Can not tolerate venous puncture blood collection or faint blood needle.
- Has special requirements for diet and cannot comply with a unified diet.
- By the investigator's decision, other factors may affect the study results and interfere with his/her participation in the study process.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei, Guangdong
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Food Effects of ARD-885 Film-coated Tablets in Healthy Chinese Subjects and Patients With Rheumatoid Arthritis
The proposed study is a randomized, double-blind, placebo-controlled single and multiple ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetic, and food effects of ARD-885 Film-coated Tablets in healthy subjects.The entire study includes 3 parts: a single ascending dose study, a multiple ascending dose study, and a food-effect bioavailability study in healthy subjects.
Read the detailed description
The whole study includes 3 parts: a single ascending dose study, a multiple ascending dose study, and a food-effect bioavailability study. The SAD and MAD studies are randomized, double-blinded, and placebo-controlled studies, and the FE study is a randomized, open-label, two-period, two-treatment (2×2) crossover study.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- ARD-885 Tablets, ARD-885 Placebo Tablet
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARD-885 TabletsDrug
ARD-885 Tablet is a dual-target inhibitor of IRAK4 and IRAK1.
ARD-885 Placebo TabletDrug
Placebo Tablet to ARD-885 tablets.
| Study group | Role | What they receive |
|---|---|---|
| ARD-885 Tablets (Multiple Administration Dose, cohort B1~B3) | Experimental | ARD-885 Tablets, 25 mg/50 mg/100 mg, once a day(QD), from Day1~Day7 Receives: Drug: ARD-885 Tablets |
| ARD-885 tablet (Single Administration Dose, cohort A0~A7) | Experimental | ARD-885 Tablets, 5/10/30/60/100/150/200/250 mg，a single dose on Day1 Receives: Drug: ARD-885 Tablets |
| ARD-885 Placebo tablet (Single Ascending Dose, cohort A1~A7) | Placebo comparator | ARD-885 Placebo tablet, a single dose on Day1 Receives: Drug: ARD-885 Placebo Tablet |
| ARD-885 Tablets (Food Effect, cohort C1~C2) | Experimental | ARD-885 tablets, 50mg, a single dose on Day1 and Day7, fed or fasted crossover Receives: Drug: ARD-885 Tablets |
| ARD-885 Placebo Tablets (Multiple Administration Dose, cohort B1~B3) | Placebo comparator | ARD-885 Placebo tablets, once a day(QD), from Day1~Day7 Receives: Drug: ARD-885 Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)/Severe Adverse Events (SAE)
Safety and tolerability are assessed by the incidence of adverse events and its severity caused by the study drug during or after dose.
Measured: The first day of the first administration until 7 days after the last administration.
Secondary outcomes (16)
PK: Cmax of ARD-885.
Pharmacokinetics (PK): Maximum observed concentration.
Measured: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: T1/2 of ARD-885.
Pharmacokinetics (PK): Apparent terminal elimination half-life.
Measured: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: Tmax of ARD-885.
Pharmacokinetics (PK): Time to reach Cmax. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value.
Measured: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: AUC0-t of ARD-885.
Pharmacokinetics (PK): The area under the plasma concentration-time curve from time 0 to concentration time.
Measured: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: AUC0-last of ARD-885.
Pharmacokinetics (PK): The area under the plasma concentration-time curve, from time 0 to the last measurable non-zero concentration.
Measured: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: AUC0-inf of ARD-885.
Pharmacokinetics (PK): The area under the plasma concentration-time curve from time 0 extrapolated to infinity.
Measured: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: CL/F of ARD-885.
Pharmacokinetics (PK): Apparent oral drug clearance.
Measured: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: Css_max of ARD-885.
Pharmacokinetics (PK): Steady-state maximum blood concentration in MAD study.
Measured: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: Css_min of ARD-885.
Pharmacokinetics (PK): Steady-state minimum blood concentration in MAD study.
Measured: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: Tss_max of ARD-885.
Pharmacokinetics (PK): Time to reach Cmax at steady state in MAD study.
Measured: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: AUCss_tau of ARD-885.
Pharmacokinetics (PK): The area under the concentration-time curve at one dosing interval after reaching a steady state in MAD study.
Measured: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: RACmax of ARD-885.
Pharmacokinetics (PK): Accumulation ratio on Cmax of ARD-885 in MAD study.
Measured: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: RAAUCtau of ARD-885
Pharmacokinetics (PK): Accumulation ratio on AUCtau in MAD study.
Measured: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PD: The concentration of TNF-α
TNF-α, IL-1β and IL-6 are a pro-inflammatory cytokines whose high expression indicating the activation of TLRs/IL-1R/NF-κB signaling pathway. Healthy Subjects in MAD study(B1~B3) will have their blood samples collected to detect levels of inflammatory factors TNF-α, IL-1β and IL-6 expression.
Measured: blood samples were collected from 1 hour before first administration to 24 hours after the last administration.
PD: The concentration of IL-6.
TNF-α, IL-1β and IL-6 are a pro-inflammatory cytokines whose high expression indicating the activation of TLRs/IL-1R/NF-κB signaling pathway. Healthy Subjects in MAD study(B1~B3) will have their blood samples collected to detect levels of inflammatory factors TNF-α, IL-1β and IL-6 expression.
Measured: blood samples were collected from 1 hour before first administration to 24 hours after the last administration.
PD: The concentration of IL-1β.
TNF-α, IL-1β and IL-6 are a pro-inflammatory cytokines whose high expression indicating the activation of TLRs/IL-1R/NF-κB signaling pathway. Healthy Subjects in MAD study(B1~B3) will have their blood samples collected to detect levels of inflammatory factors TNF-α, IL-1β and IL-6 expression.
Measured: blood samples were collected from 1 hour before first administration to 24 hours after the last administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start16 Dec 2024
- Primary completion14 Aug 2025
- Study completion18 Aug 2025
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artivila (Shenzhen) Innovation Center, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266207
- Sponsor's protocol ID
- KHZY-ARD885-001
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Food Effects of ARD-885 Film-coated Tablets in Healthy Chinese Subjects and Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07266207
- Acronym / sponsor ID
- KHZY-ARD885-001
- Conditions
- Rheumatoid Arthritis (RA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Artivila (Shenzhen) Innovation Center, LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 5 Dec 2025 (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 proposed study is a randomized, double-blind, placebo-controlled single and multiple ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetic, and food effects of ARD-885 Film-coated Tablets in healthy subjects.The entire study includes 3 parts: a single ascending dose study, a multiple ascending dose study, and a food-effect bioavailability study in healthy subjects.
Detailed description
The whole study includes 3 parts: a single ascending dose study, a multiple ascending dose study, and a food-effect bioavailability study. The SAD and MAD studies are randomized, double-blinded, and placebo-controlled studies, and the FE study is a randomized, open-label, two-period, two-treatment (2×2) crossover study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ARD-885 Tablets (Multiple Administration Dose, cohort B1~B3) | Experimental | Drug: ARD-885 TabletsARD-885 Tablets, 25 mg/50 mg/100 mg, once a day(QD), from Day1~Day7 |
| ARD-885 tablet (Single Administration Dose, cohort A0~A7) | Experimental | Drug: ARD-885 TabletsARD-885 Tablets, 5/10/30/60/100/150/200/250 mg，a single dose on Day1 |
| ARD-885 Placebo tablet (Single Ascending Dose, cohort A1~A7) | Placebo comparator | Drug: ARD-885 Placebo TabletARD-885 Placebo tablet, a single dose on Day1 |
| ARD-885 Tablets (Food Effect, cohort C1~C2) | Experimental | Drug: ARD-885 TabletsARD-885 tablets, 50mg, a single dose on Day1 and Day7, fed or fasted crossover |
| ARD-885 Placebo Tablets (Multiple Administration Dose, cohort B1~B3) | Placebo comparator | Drug: ARD-885 Placebo TabletARD-885 Placebo tablets, once a day(QD), from Day1~Day7 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All subjects:
Key exclusion criteria (19 listed)
- Known or suspected allergy to any component of ARD-885 Film-coated Tablets, or individuals with a hypersensitivity to allergies (multiple drug and food allergies), as determined by the investigator, and deemed unsuitable for inclusion.
- Lactating women; Women of reproductive age with menstrual disorders within 90 days before administration; Women of childbearing age who have had unprotected sexual intercourse with an opposite-sex partner in the 28 days before administration. Female subjects who are lactating or have a positive serum pregnancy result during the screening period or during the trial.
- Participated in any drug clinical trial within 90 days before administration, or the administration date of this study is still within the safety washout period specified in the previous drug clinical trial.
- Non-physiological blood loss ≥ 200 ml within 60 days before administration (including trauma, blood collection, blood donation); Or plan to donate blood during the trial or within 30 days of administration.
- Had a major disease that investigators considered clinically significant within 90 days before first administration; Have any active malignancy or history of malignancy in the 5 years prior to screening, with the exception of treated and considered cured skin squamous or basal cell carcinoma, cervical carcinoma in situ, or breast ductal carcinoma in situ.
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 |
|---|---|---|
| ARD-885 TabletsARD-885 Tablet is a dual-target inhibitor of IRAK4 and IRAK1. | Drug | ARD-885 Tablets (Food Effect, cohort C1~C2), ARD-885 Tablets (Multiple Administration Dose, cohort B1~B3), ARD-885 tablet (Single Administration Dose, cohort A0~A7) |
| ARD-885 Placebo TabletPlacebo Tablet to ARD-885 tablets. | Drug | ARD-885 Placebo Tablets (Multiple Administration Dose, cohort B1~B3), ARD-885 Placebo tablet (Single Ascending Dose, cohort A1~A7) |
Primary outcome
Adverse Events (AE)/Severe Adverse Events (SAE)
Time frame: The first day of the first administration until 7 days after the last administration.
Safety and tolerability are assessed by the incidence of adverse events and its severity caused by the study drug during or after dose.
16 secondary outcomes
PK: Cmax of ARD-885.
Time frame: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: T1/2 of ARD-885.
Time frame: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: Tmax of ARD-885.
Time frame: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: AUC0-t of ARD-885.
Time frame: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: AUC0-last of ARD-885.
Time frame: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: AUC0-inf of ARD-885.
Time frame: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: CL/F of ARD-885.
Time frame: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: Css_max of ARD-885.
Time frame: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: Css_min of ARD-885.
Time frame: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: Tss_max of ARD-885.
Time frame: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: AUCss_tau of ARD-885.
Time frame: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: RACmax of ARD-885.
Time frame: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PK: RAAUCtau of ARD-885
Time frame: Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.
PD: The concentration of TNF-α
Time frame: blood samples were collected from 1 hour before first administration to 24 hours after the last administration.
PD: The concentration of IL-6.
Time frame: blood samples were collected from 1 hour before first administration to 24 hours after the last administration.
PD: The concentration of IL-1β.
Time frame: blood samples were collected from 1 hour before first administration to 24 hours after the last administration.
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 5 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARD-885 Tablets in people with Rheumatoid Arthritis (RA), run by Artivila (Shenzhen) Innovation Center, Ltd at 1 site in China.
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 5 inclusion and 19 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 5 Dec 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?
Adverse Events (AE)/Severe Adverse Events (SAE) (time frame: The first day of the first administration until 7 days after the last administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2025.