CIGB-814 safety and how the body handles it in healthy Chinese adults

A Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Pharmacodynamics of Single and Multiple Doses of CIGB-814 in Healthy Participants

We will test whether CIGB-814 is safe, well-tolerated, and how the body processes it in healthy Chinese adults aged 18–45.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07182656 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, randomized, placebo-controlled study using single- and multiple-dose cohorts in healthy Chinese adults to measure safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CIGB-814. Participants will be assigned to single-dose or multiple-dose groups with matching placebo arms and will have serial blood sampling to measure drug levels, immune markers, and antibody responses. Secondary and exploratory endpoints include preliminary PD, immunogenicity, and detailed profiling of immune cell subsets and signaling pathways after repeated dosing. The trial is conducted at Peking University People's Hospital in Beijing with close monitoring for adverse events.

Who should consider this trial

Good fit: Healthy men and women aged 18–45 with BMI 19.0–26.0 (minimum weight thresholds apply), able to give informed consent, and not planning pregnancy or gamete donation are eligible.

Not a fit: People with active rheumatoid arthritis, those outside the age or BMI ranges, pregnant people or those planning pregnancy, and individuals with significant medical conditions are not eligible and are unlikely to gain direct benefit from participation.

Why it matters

Potential benefit: If successful, the trial could identify safe dosing and early immune effects that help advance CIGB-814 toward testing as a new treatment option for rheumatoid arthritis.

How similar studies have performed: Peptide-based immunotherapies and early-phase trials of similar agents have shown preliminary immune activity in humans, but clinical benefit in rheumatoid arthritis has not yet been established.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yi Fang, MD

Conditions Rheumatoid Arthritis