HealthyPhase 1NCT06549959
A Single Dose Study to Investigate the Pharmacokinetics (PK) of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects
A Phase 1 study testing Telitacicept Pre-filled Injection 80mg and Telitacicept Freeze-dried powder Injection 80mg in people with Healthy, run by RemeGen Co., Ltd. at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Telitacicept Pre-filled Injection 80mg and Telitacicept Freeze-dried powder Injection 80mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 3 sitesChina
- Study dates
- 5 Aug 2024to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 clinical significance；
- 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 requirements.
Who cannot join
- 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 diseases that are not suitable for clinical trials (such as mental history, malignant tumors, etc.);
- History of lymphoproliferative disease (e.g., EB virus associated lymphoproliferative disease), lymphoma, leukemia, myeloproliferative disease, multiple myeloma, or signs and symptoms suggestive of lymphoproliferative disease;
- 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, postpartum hemorrhage, vitamin K deficiency, hemorrhagic disease caused by acquired coagulation factor antibodies, bleeding after trauma or surgery, etc.) , or abnormal laboratory coagulation parameters, or an inherited tendency to bleed or have coagulation dysfunction, or have a history of blood clots or bleeding, or require long-term use of anticoagulants or antiplatelet aggregation drugs;
- 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 not inappropriate;
- The first-degree relatives of the subject had inherited immunodeficiency;
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- 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; inhibitors--SSRI antidepressants, cimetidine, Diltiazem macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines);
- 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 or 150ml of wine), or unable to stop drinking during the trial;
- 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 (≥1100 mL per day), chocolate (≥510 g per day);
- 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 subjects with a positive pregnancy test during screening period，or lactating female ; subjects and their partners do not agree to take effective contraceptive measures (such as intrauterine devices, contraceptives or condoms) throughout the trial and within 4 months after injection of the Investigational drug;
- Investigators believe that there are other factors that are not suitable for participating in the experiment.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Qi Shen, PhD, 86-13228212376, 769824157@qq.com
- Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
Yan He, PhD, 86-18984058185, physicianheyan@126.com
- Recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300191
Wei Cui, Bachelor, 86-022-27557550, 13802169921@163.com
About this study
Official title: An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the Pharmacokinetics of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects
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
- Healthy
- Being tested
- Telitacicept Pre-filled Injection 80mg, Telitacicept Freeze-dried powder Injection 80mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telitacicept Pre-filled Injection 80mgDrug
The patient received one treatment of Telitacicept 80mg in the test group
Telitacicept Freeze-dried powder Injection 80mgDrug
The patient received one treatment of Telitacicept 80mg in the test group
| Study group | Role | What they receive |
|---|---|---|
| Telitacicept Pre-filled Injection 80mg | Experimental | Not described Receives: Drug: Telitacicept Pre-filled Injection 80mg |
| Telitacicept Freeze-dried powder Injection 80mg | Experimental | Not described Receives: Drug: Telitacicept Freeze-dried powder Injection 80mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-max
Maximum observed plasma concentration
Measured: Day 0#Day 1#Day 2#Day 3#Day 5#Day 8#Day 15#Day 22#Day 29#Day 43#Day 57
AUC0-∞
Area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration
Measured: Day 0#Day 1#Day 2#Day 3#Day 5#Day 8#Day 15#Day 22#Day 29#Day 43#Day 57
Secondary outcomes (2)
T-max
Time to reach maximum observed plasma concentration
Measured: Day 0#Day 1#Day 2#Day 3#Day 5#Day 8#Day 15#Day 22#Day 29#Day 43#Day 57
Evaluation of AEs (adverse events)
Through observing number of total AEs and number of subjects with AEs and other factors of AEs #to evaluate the safety and tolerance of healthy subjects.
Measured: Up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start5 Aug 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549959
- Sponsor's protocol ID
- 18C033
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the Pharmacokinetics of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT06549959
- Acronym / sponsor ID
- 18C033
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telitacicept Pre-filled Injection 80mg | Experimental | Drug: Telitacicept Pre-filled Injection 80mg |
| Telitacicept Freeze-dried powder Injection 80mg | Experimental | Drug: Telitacicept Freeze-dried powder Injection 80mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 clinical significance；
- 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 requirements.
Key exclusion criteria (24 listed)
- 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 diseases that are not suitable for clinical trials (such as mental history, malignant tumors, etc.);
- History of lymphoproliferative disease (e.g., EB virus associated lymphoproliferative disease), lymphoma, leukemia, myeloproliferative disease, multiple myeloma, or signs and symptoms suggestive of lymphoproliferative disease;
- 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, postpartum hemorrhage, vitamin K deficiency, hemorrhagic disease caused by acquired coagulation factor antibodies, bleeding after trauma or surgery, etc.) , or abnormal laboratory coagulation parameters, or an inherited tendency to bleed or have coagulation dysfunction, or have a history of blood clots or bleeding, or require long-term use of anticoagulants or antiplatelet aggregation drugs;
- 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 not inappropriate;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telitacicept Pre-filled Injection 80mgThe patient received one treatment of Telitacicept 80mg in the test group | Drug | Telitacicept Pre-filled Injection 80mg |
| Telitacicept Freeze-dried powder Injection 80mgThe patient received one treatment of Telitacicept 80mg in the test group | Drug | Telitacicept Freeze-dried powder Injection 80mg |
Primary outcome
C-max
Time frame: Day 0#Day 1#Day 2#Day 3#Day 5#Day 8#Day 15#Day 22#Day 29#Day 43#Day 57
Maximum observed plasma concentration
AUC0-∞
Time frame: Day 0#Day 1#Day 2#Day 3#Day 5#Day 8#Day 15#Day 22#Day 29#Day 43#Day 57
Area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration
2 secondary outcomes
T-max
Time frame: Day 0#Day 1#Day 2#Day 3#Day 5#Day 8#Day 15#Day 22#Day 29#Day 43#Day 57
Evaluation of AEs (adverse events)
Time frame: Up to Day 57
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telitacicept Pre-filled Injection 80mg and Telitacicept Freeze-dried powder Injection 80mg in people with Healthy, run by RemeGen Co., Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binghua Xiao (86-010-58076833, binghua.xiao@remegen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-max (time frame: Day 0#Day 1#Day 2#Day 3#Day 5#Day 8#Day 15#Day 22#Day 29#Day 43#Day 57). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.