Actively Recruiting
A Single Dose Study to Investigate the Pharmacokinetics (PK) of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects
Led by RemeGen Co., Ltd. · Updated on 2024-08-12
248
Participants Needed
3
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to evaluate the Pharmacokinetics and safety of Telitacicept Pre-filled Injection and Freeze-dried powder Injection.
CONDITIONS
Official Title
A Single Dose Study to Investigate the Pharmacokinetics (PK) of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 50 years old at the time of consent, any gender
- Male weight between 55 and 70 kg, female weight between 50 and 65 kg
- Body mass index (BMI) between 18 and 28 kg/m2, including limits
- Normal or clinically insignificant abnormal physical exam, vital signs, chest X-ray, ECG, epidemiologic tests, blood tests, biochemistry, lipids, urinalysis, and coagulation
- Able to understand study purpose and procedures, voluntarily agree to participate, and sign informed consent
- Able to complete all study procedures as required
You will not qualify if you...
- Site staff, sponsor staff, or their family members involved in the trial
- History of nervous, cardiovascular, digestive, respiratory, urinary, blood, muscle, immune, metabolic diseases, mental illness, or cancer
- History or signs of lymphoproliferative diseases such as lymphoma or leukemia
- History of abnormal bleeding, coagulation disorders, blood clots, or long-term use of anticoagulants or antiplatelet drugs
- Abnormal ECG findings including prolonged QTc interval or significant blocks
- First-degree relatives with inherited immunodeficiency
- Current allergies or history of allergies to protein products, alcohol, or multiple drugs/non-drug factors
- Surgery within 6 months before screening or planned surgery during the trial
- Participation in another drug trial within 3 months before screening
- Use of drugs affecting liver metabolism within 4 weeks before randomization or during the trial
- Use of any medications, including herbal or vitamins, within 14 days before randomization
- History of significant blood donation or bleeding within 3 months before screening or plans to donate blood within 1 month after trial
- Positive alcohol breath test or history of alcoholism in past 6 months or inability to stop drinking during trial
- Smoking more than 5 cigarettes per day in past 6 months or inability to quit during trial
- Excessive caffeine intake within 4 weeks before screening
- History of drug abuse or dependence within 5 years before screening
- Use of weight-loss drugs, excessive dieting, or overeating during trial
- Tattoos, scars, or conditions at planned injection site
- COVID-19 vaccine within 2 weeks before randomization or live vaccine within 30 days before or during trial
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or tuberculosis
- History of serious infections in past 6 months
- Recent or multiple episodes of herpes zoster or herpes simplex infections
- Female pregnancy, lactation, or unwillingness to use effective contraception during and 4 months after trial
- Other investigator-determined factors unsuitable for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
Actively Recruiting
2
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
3
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China, 300191
Actively Recruiting
Research Team
B
Binghua Xiao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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