New rheumatoid arthritis drug candidate begins first human tests
NCT ID NCT07182656
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage study is testing a new drug called CIGB-814 for safety and how the body processes it. 70 healthy volunteers aged 18-45 will receive either the drug or a placebo as a single or multiple injections. The goal is to see if it is safe enough to test in people with rheumatoid arthritis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CIGB-814
- What this could lead to
- If successful, this could lead to a new treatment option for rheumatoid arthritis that helps control the disease.
- What could go wrong
- This is a very early Phase 1 trial in healthy people, not patients. It only tests safety and dosing, not whether it works for arthritis. Many early-stage drugs fail to show benefit later.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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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: * Participants must meet all of the following criteria to be eligible for the study: 1. Healthy male or female participants aged 18 to 45 years, inclusive. 2. Male participants weighing at least 50.0 kg, and female participants weighing at least 45.0 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m², inclusive (BMI = weight \[kg\] / height² \[m²\]). 3. Able to communicate effectively with the investigators, understand and comply with all study requirements, and willing to adhere strictly to the study procedures and follow-up schedule. Participants must provide written informed consent prior to any study-related procedures. 4. From the date of signing the informed consent until 6 months after study completion, participants must not have plans for conception. Female participants must not have plans to donate oocytes and agree to use reliable contraception to avoid pregnancy. Male participants must not have plans to donate sperm and agree to use reliable contraception to prevent pregnancy of their partner. Exclusion Criteria: * Participants meeting any of the following criteria will be excluded from the study: 1.History or presence of any clinically significant disease, including but not limited to: 1. Respiratory (e.g., past or active tuberculosis), cardiovascular, gastrointestinal, urinary, musculoskeletal, endocrine (e.g., adrenal insufficiency), neurological or psychiatric (e.g., epilepsy), hematologic (particularly any hemolytic disorders such as glucose-6-phosphate dehydrogenase \[G6PD\] deficiency or paroxysmal nocturnal hemoglobinuria \[PNH\]), immune system disorders, or known significant bleeding tendencies; 2. Fever or infectious disease within 3 days prior to screening; 3. History of gastrointestinal, liver, or kidney diseases, including prior partial resection of these organs; 4. Severe infection, trauma, or surgery within 12 weeks prior to screening, or planned surgery during the study deemed unsuitable by the investigator; 5. Clinically significant acute illness (e.g., gastrointestinal disorders, infections) within 4 weeks prior to screening; 6. Chronic pain (persistent or recurrent for \>3 months) or currently experiencing acute pain (\<3 months). 2.History of significant allergies, including known hypersensitivity to any investigational product or its components, food allergies, pollen allergies, or other allergic conditions. 3.Smoking more than 5 cigarettes per day (or equivalent tobacco use) within 3 months prior to screening, or inability to abstain from tobacco during the study. 4.History of alcohol abuse, average alcohol consumption ≥14 units/week within 3 months prior to screening (1 unit = 10 mL ethanol, e.g., 200 mL beer \[5%\], 25 mL spirits \[40%\], or 83 mL wine \[12%\]), positive alcohol breath test at admission, or inability to abstain from alcohol during the study. 5.Excessive consumption of tea, coffee, or other caffeinated beverages (average \>8 cups/day, 1 cup = 250 mL) within 3 months prior to screening. 6.Inability to refrain from caffeine-containing foods or beverages (e.g., coffee, strong tea, cola, chocolate) within 72 hours prior to admission or during the study, or consumption of other foods affecting drug absorption, distribution, metabolism, or excretion (e.g., dragon fruit, mango, grapefruit, pomelo, orange, starfruit, guava). 7.Participation in another clinical trial involving drugs or devices within 3 months prior to screening, or use of investigational products prior to first admission. 8.Vaccination (including but not limited to COVID-19, tetanus, rabies, HPV) within 2 months prior to screening. 9.Blood donation or significant blood loss (≥400 mL) within 3 months prior to screening, transfusion or use of blood products within 3 months prior, blood loss ≥200 mL within 30 days, or plasma/aphresis donation within 7 days prior. 10.Use of prescription drugs, over-the-counter drugs, herbal medicines, or dietary supplements within 14 days prior to screening or between screening and first admission. 11.History of syncope related to needles or blood, difficulty with blood collection, or orthostatic hypotension. 12.Special dietary requirements preventing adherence to a standardized diet. 13.History of substance abuse or drug addiction, or positive test for addictive substances (methamphetamine, MDMA, THC, morphine, ketamine) on the day of admission. 14.Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test. 15.Abnormal vital signs, physical examination, laboratory tests, ECG, CT, or ultrasound deemed clinically significant by the investigator. 16.Women using oral contraceptives within 30 days prior to screening or during the study, or long-acting estrogen/progestin injections or implants within 6 months prior to screening or during the study. 17.Positive test for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis (Treponema pallidum) antibody. 18.Any other condition or factor deemed by the investigator to make the participant unsuitable for the study. \*Chronic pain is defined as persistent or recurrent pain lasting more than 3 months. Acute pain is defined as pain lasting less than 3 months.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University People's Hospital
RECRUITINGBeijing, Beijing Municipality, 101149, China
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