Actively Recruiting
Safety, Tolerability, and PK/PD of CIGB-814 in Chinese Health Participants
Led by Yi Fang · Updated on 2025-09-19
70
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety, Tolerability, and PK/PD of CIGB-814 in Chinese Health Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males or females aged 18 to 45 years
- Males must weigh at least 50.0 kg; females must weigh at least 45.0 kg
- Body mass index between 19.0 and 26.0 kg/m²
- Ability to communicate, understand, and follow study procedures
- Willingness to avoid conception and use reliable contraception from consent until 6 months after study completion
You will not qualify if you...
- Any clinically significant disease including respiratory, cardiovascular, gastrointestinal, urinary, musculoskeletal, endocrine, neurological, psychiatric, hematologic, immune, or bleeding disorders
- Fever or infectious disease within 3 days prior to screening
- History of gastrointestinal, liver, or kidney disease or prior organ resection
- Severe infection, trauma, or surgery within 12 weeks prior to screening or planned surgery during study
- Acute illness within 4 weeks prior to screening
- Chronic pain lasting more than 3 months or acute pain less than 3 months
- History of significant allergies or hypersensitivity to investigational products or components
- Smoking more than 5 cigarettes per day within 3 months prior to screening or inability to abstain during study
- Alcohol abuse or consumption of 14 or more units per week within 3 months prior to screening or inability to abstain during study
- Excessive caffeine intake (more than 8 cups per day) within 3 months prior to screening
- Inability to refrain from caffeine or foods affecting drug absorption within 72 hours prior to admission or during study
- Participation in another clinical trial or investigational product use within 3 months prior to screening
- Vaccination within 2 months prior to screening
- Blood donation or significant blood loss within specified timeframes prior to screening
- Use of drugs, herbal medicines, or supplements within 14 days prior to screening
- History of syncope or blood collection difficulties
- Special dietary requirements preventing adherence to study diet
- History of substance abuse or positive test for addictive substances on admission
- Pregnant or breastfeeding women or positive pregnancy test
- Abnormal vital signs or tests deemed clinically significant
- Use of oral contraceptives or long-acting hormonal contraceptives within specified times
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Any condition making participant unsuitable as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 101149
Actively Recruiting
Research Team
Y
Yi Fang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here