BridgeMD
New treatment option for Healthy
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
ClinicalTrials.gov ID: NCT06549959
What this study is testing
What is Telitacicept Pre-filled Injection 80mg?
Telitacicept Pre-filled Injection 80mg is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- 18-50 years old at the time of signing the informed consent form，gender is unlimited；
- Male Weight 55-70 kg, female Weight 50-65 kg, and BMI ranging from 18 to 28 kg/m2 (including critical values);
- Physical examination, vital signs, chest radiographs, ECG, epidemiologic tests, routine blood tests, blood biochemistry, lipids, urinalysis, and...
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and...
You likely can't join if
- Site staff and family members directly involved in the trial; or sponsor staff and family members directly involved in the implementation of the...
- History of any of any nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood and lymphatic system...
- History of lymphoproliferative disease (e.g., EB virus associated lymphoproliferative disease), lymphoma, leukemia, myeloproliferative disease...
- History of abnormal bleeding or coagulation disorders (such as prone to bruising, gingival bleeding, prolonged bleeding after tooth extraction, joint...
- During screening, 12-lead ECG showing QTcF≥450 ms in male or QTcF≥470 ms in female, or the presence of degree II/III atrioventricular block, or other...
- The first-degree relatives of the subject had inherited immunodeficiency;
See the full eligibility criteria
- 18-50 years old at the time of signing the informed consent form，gender is unlimited；
- Male Weight 55-70 kg, female Weight 50-65 kg, and BMI ranging from 18 to 28 kg/m2 (including critical values);
- Physical examination, vital signs, chest radiographs, ECG, epidemiologic tests, routine blood tests, blood biochemistry, lipids, urinalysis, and coagulation are normal，or abnormal by the investigator as having no...
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and be able to complete all trial procedures according to the trial...
- Site staff and family members directly involved in the trial; or sponsor staff and family members directly involved in the implementation of the trial;
- History of any of any nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood and lymphatic system, skeletal muscle system, immune system, metabolic system disease, or other...
- History of lymphoproliferative disease (e.g., EB virus associated lymphoproliferative disease), lymphoma, leukemia, myeloproliferative disease, multiple myeloma, or signs and symptoms suggestive of lymphoproliferative...
- History of abnormal bleeding or coagulation disorders (such as prone to bruising, gingival bleeding, prolonged bleeding after tooth extraction, joint hemorrhage, heavy menstruation leading to anemia within 1 year...
- During screening, 12-lead ECG showing QTcF≥450 ms in male or QTcF≥470 ms in female, or the presence of degree II/III atrioventricular block, or other clinically significant ECG abnormalities are judged by investigators...
- The first-degree relatives of the subject had inherited immunodeficiency;
- Current allergic disease, or history of allergy to therapeutic or diagnostic protein products ,allergy to alcohol(alcohol is used to sterilize injection sites), or allergy to two or more drugs and/or non-drug factors;
- Surgery within 6 months prior to screening, or planned surgery during the trial, or within 2 weeks of the end of the trial(including cosmetic surgery, dental surgery, oral surgery, etc.);
- Participation in a clinical trial of another drug within 3 months prior to screening;
- Use of drugs that inhibit or induce hepatic metabolism within 4 weeks prior to randomization or need for use during the trial(e.g., inducers--barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole...
- Current use of any prescription or over-the-counter (herbal, vitamins, or healthcare products). Current use is defined as use within 14 days or PK equivalent of 5 half-lives prior to randomization, whichever is longer;
- History of Bleeding or donated more than 100ml blood 3 months before screening period, or plan to denote blood within 1 month after the trial;
- Positive breath test results for alcohol or alcoholism in the 6 months prior to the screening period(≥14 units of alcohol per week: one standard unit contains 14g of alcohol, equals to 360ml of beer, 45ml of 40% liquor...
- More than 5 cigarettes per day within 6 months prior to screening , or unable to quit smoking during the trial;
- Consume excessive caffeine-containing beverages, foods that may affect drug metabolism within four weeks prior to screening: coffee (≥1100 mL per day), tea (≥2200 mL per day), cola (≥2200 mL per day), energy drinks...
- History of drug abuse, drug dependence, or drug use within 5 years prior to screening；
- Subject may use weight-loss medications, or excessive dieting, or overeating during the trial;
- Tattoos, scarring, or other conditions in the planned injection site area (front of thigh) that may interfere with the evaluation of the injection site;
- COVID-19 vaccine within 2 weeks prior to randomization，or live vaccine within 30 days prior to randomization， or live vaccine required during the trial;
- Positive test for Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, tuberculin test (IGRAs);
- History of any clinically significant infections within 6 months prior to screening (e. g., requiring hospitalization or parenteral antimicrobial therapy or opportunistic infections);
- History of symptomatic herpes zoster or herpes simplex, more than one episode of localized herpes zoster, or disseminated herpes zoster (single episode) within 12 weeks prior to screening；
- Female people with a positive pregnancy test during screening period，or lactating female ; people and their partners do not agree to take effective contraceptive measures (such as intrauterine devices, contraceptives or...
- Investigators believe that there are other factors that are not suitable for participating in the experiment.
The study team makes the final eligibility decision.
Where it's taking place
- Guiyang, Guizhou, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guiyang, Guizhou, China; Chengdu, Sichuan, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.