Actively Recruiting
Clinical Study of Recombinant Humanized CTLA-4-FC Fusion Protein Injection in Healthy Subjects
Led by Beijing VDJBio Co., LTD. · Updated on 2024-05-07
46
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, randomized, double-blind, does-escalation Phase I Clinical Study that aim to evaluate the tolerability, safety and PK Characteristics of recombinant humanized CTLA-4-FC fusion protein injection in Healthy Subjects.
CONDITIONS
Official Title
Clinical Study of Recombinant Humanized CTLA-4-FC Fusion Protein Injection in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy individuals aged 18 to 45 years with no significant abnormalities in medical history, physical exam, ECG, imaging, or lab tests
- Male or female participants
- Males must weigh at least 50.0 kg; females must weigh at least 45.0 kg
- Body mass index (BMI) between 19.0 and 25.0 kg/m2
- Women of reproductive age must use reliable contraception during the study and for 3 months after
- Fertile men must use reliable contraception during the study and for 3 months after
- Voluntary participation with signed informed consent
You will not qualify if you...
- Known or suspected allergy to the study drug, its excipients, alcohol, iodine, heparin, or history of allergy to drugs, food, or pollen
- Plans for fertility or sperm/egg donation during the study and 3 months after
- Positive pregnancy test or lactating females
- Use of oral contraceptives within 30 days or long-acting hormonal treatments within 6 months prior to the study
- History or presence of central nervous system, cardiovascular, liver, kidney, digestive, respiratory, skeletal, or mental health disorders that could affect study results
- Acute or chronic bacterial infection within 3 months or signs of infection at enrollment
- Major surgery within 4 weeks prior or planned surgery during the study
- Herpes zoster remission less than 2 months before enrollment
- Abnormal vital signs or body temperature over 37.3°C
- Abnormal blood test results including white blood cells, neutrophils, platelets, hemoglobin, bilirubin, creatinine, AST, ALT
- Risk factors or history of tuberculosis
- Positive tests for HIV, hepatitis B or C, or syphilis
- History of drug or alcohol abuse or positive drug screen within 6 months
- Blood donation within 3 months prior or planned during study and 1 month after
- Blood transfusion within 4 weeks prior
- Smoking history over 6 months and over 5 cigarettes per day
- High consumption of caffeine or tea
- Use of prescription, over-the-counter, or herbal medicines within 5 half-lives or 14 days prior to dosing
- Vaccination or immunotherapy within 3 months prior or planned vaccination during study or within 3 months after
- History of needle or blood sickness
- Participation in other drug clinical trials within 3 months prior or planned participation during study
- Other reasons deemed by investigator for ineligibility
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, China
Actively Recruiting
Research Team
X
Xiaoming Gong, Msc
CONTACT
Y
Yi Fang, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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