Safety, Tolerability, and PK/PD of CIGB-814 in Chinese Health Participants

NCT07182656 | Recruiting Phase 1

• 1 other identifier: SDLK-20250425PK-CIGB814
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of CIGB-814 for injection after single and multiple administrations in healthy participants. Secondary objectives include the assessment of preliminary pharmacodynamics (PD) and immunogenicity. Exploratory objectives are to investigate changes in immune cell subsets and signaling pathways following multiple administrations of CIGB-814.

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (4)

• Cmax

  Cmax after single-dose administration and Cmax after the first dose in the multiple-dose group

  Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.

• Tmax

  Tmax after single-dose administration and Tmax after the first dose in the multiple-dose group

  Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.

• AUC0-t

  AUC0-t after single-dose administration and AUC0-t after the first dose in the multiple-dose group

  Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.

• AUC0-∞

  AUC0-∞ after single-dose administration and AUC0-∞ after the first dose in the multiple-dose group

  Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.

Secondary Outcomes (20)

• t1/2

  Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.

• λz

  Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.

• AUC_%Extrap

  Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.

• Css_min

  Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.

• Css_max

  Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.

Study Arms (4)

CIGB-814 (single-dose group)

EXPERIMENTAL

Drug: CIGB-814 (single-dose group)

CIGB-814 placebo (single-dose group)

PLACEBO COMPARATOR

Drug: CIGB-814 placebo (single-dose group)

CIGB-814 (multiple-dose group)

EXPERIMENTAL

Drug: CIGB-814 (multiple-dose group)

CIGB-814 placebo (multiple-dose group)

PLACEBO COMPARATOR

Drug: CIGB-814 placebo (multiple-dose group)

Interventions

CIGB-814 (single-dose group) DRUG

CIGB-814, single ascending dose, SC injection

CIGB-814 (single-dose group)

CIGB-814 placebo (single-dose group) DRUG

CIGB-814 placebo, single ascending dose, SC injection

CIGB-814 placebo (single-dose group)

CIGB-814 (multiple-dose group) DRUG

CIGB-814, multiple ascending dose, SC injection

CIGB-814 (multiple-dose group)

CIGB-814 placebo (multiple-dose group) DRUG

CIGB-814 placebo, multiple ascending dose, SC injection

CIGB-814 placebo (multiple-dose group)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet all of the following criteria to be eligible for the study:
• Healthy male or female participants aged 18 to 45 years, inclusive.
• 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 \[m²\]).
• 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.
• 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.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from the study:
• History or presence of any clinically significant disease, including but not limited to:
• 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;
• Fever or infectious disease within 3 days prior to screening;
• History of gastrointestinal, liver, or kidney diseases, including prior partial resection of these organs;
• Severe infection, trauma, or surgery within 12 weeks prior to screening, or planned surgery during the study deemed unsuitable by the investigator;
• Clinically significant acute illness (e.g., gastrointestinal disorders, infections) within 4 weeks prior to screening;
• Chronic pain (persistent or recurrent for \>3 months) or currently experiencing acute pain (\<3 months).
• History of significant allergies, including known hypersensitivity to any investigational product or its components, food allergies, pollen allergies, or other allergic conditions.
• 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.
• 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.
• Excessive consumption of tea, coffee, or other caffeinated beverages (average \>8 cups/day, 1 cup = 250 mL) within 3 months prior to screening.
• 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).
• Participation in another clinical trial involving drugs or devices within 3 months prior to screening, or use of investigational products prior to first admission.
• Vaccination (including but not limited to COVID-19, tetanus, rabies, HPV) within 2 months prior to screening.

Sponsors & Collaborators

• Yi Fang: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 101149, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

Yi Fang, MD

CONTACT

010-66583834; fygk7000@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pharmacy

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 19, 2025
• Study Start: August 18, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

CN (1)