New pill for rheumatoid arthritis enters first human tests
NCT ID NCT07266207
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested ARD-885, a new oral drug that targets two proteins involved in inflammation, in 94 healthy volunteers and people with rheumatoid arthritis. The main goal was to check safety and how the body processes the drug. Researchers gave single and multiple doses, and also looked at the effect of food. This is a first step to see if the drug is safe enough for larger studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ARD-885 tablets (a drug that targets inflammation pathways)
- What this could lead to
- If successful, this could lead to a new oral treatment option for rheumatoid arthritis that helps control joint inflammation and pain.
- What could go wrong
- This is a very early Phase 1 trial focused on safety and dosing, not on effectiveness. The drug may not work or could have side effects. Results in healthy people may not apply to RA patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
94 people
The number who actually took part.
- Started
-
Dec 2024
- Finished
-
Aug 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * All subjects: 1. 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. 2. 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. 3. 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. 4. 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. Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. Had major surgery within 60 days of administration, or had any surgery within 28 days of administration. 7. Infectious diseases such like fever and so on within 28 days before administration. 8. Previous use of any of the drugs or treatments listed in protocol. 9. Received vaccine or live attenuated vaccine within 1 month before administration, or who plan to receive the vaccine during the trial period. 10. 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). 11. Those who test positive for urine drugs or have a history of drug abuse or use of drugs in the past five years. 12. +Positive for Treponema pallidum antibodies, hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibodies or human immunodeficiency virus antibodies. 13. Those who is diagnosed as tuberculosis or have a history of non-tuberculous mycobacterial infections 14. 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.. 15. 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. 16. 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. 17. Those who Can not tolerate venous puncture blood collection or faint blood needle. 18. Has special requirements for diet and cannot comply with a unified diet. 19. By the investigator's decision, other factors may affect the study results and interfere with his/her participation in the study process.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Rheumatoid arthritis (RA) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The Second Affiliated Hospital of Anhui Medical University
Hefei, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to dozens of diseases
- Smartphone app aims to catch rheumatoid arthritis before it takes hold
- A patient questionnaire may rival lab tests for spotting rheumatoid arthritis flares
- Could fewer pills mean same relief for rheumatoid arthritis?
- Can a single cell therapy calm multiple autoimmune diseases?
- Heart risk in rheumatoid arthritis: could a blood vessel drug help?