Health VolunteerPhase 1NCT05256719
Clinical Study of Recombinant Humanized CTLA-4-FC Fusion Protein Injection in Healthy Subjects
A Phase 1 study testing Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg, Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg and Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg in people with Health Volunteer, run by Beijing VDJBio Co., LTD. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Volunteer
- What is being tested?
- Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg, Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg and Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2021to 31 Dec 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For healthy subjects, health was defined as no abnormality or no abnormality of clinical significance during the screening period, such as medical history, physical examination, electrocardiogram, imaging, and laboratory results;
- Male or female subjects, between 18 and 45 years old (including boundary values);
- Male subjects should weigh no less than 50.0 kg and female subjects should weigh no less than 45.0 kg. Body mass index (BMI) between 19.0 and 25.0 kg/m2 (including critical value),BMI= weight (kg)/ height 2(m2);
- Women of reproductive age must use a reliable method of contraception to avoid pregnancy throughout the study period, 4 weeks prior to administration and 3 months after the end of the study, and fertile men must use a reliable method of contraception to avoid pregnancy during the study period and 3 months after the end of the study;
- Subjects voluntarily participated in the study and signed informed consent.
Who cannot join
- Allergic disposition, known or suspected allergy to the test drug or any excipients (disodium hydrogen phosphate and mannitol) or allergy to alcohol/iodine (or iodophor)/ heparin or a history of allergy to any drug, food or pollen, or abnormal serum immunoglobulin E(IgE) tests, conforming to any of these conditions;
- Have a fertility plan or sperm/egg donation plan during the study period and within 3 months after the study; Female subjects have positive urine/blood pregnancy test at baseline, or are lactating;
- Female subjects who took oral contraceptives 30 days before and during the trial, or who used long-acting estrogen or progesterone injections or implants 6 months before and during the trial;
- Patients with central nervous system, cardiovascular system, liver and kidney dysfunction, digestive system, respiratory system and skeletal system diseases (including but not limited to arrhythmia, bradycardia, hypotension, coronary heart disease, bronchial asthma, diabetes, hyperthyroidism, Parkinson's disease, epilepsy, paralysis tremor) Or a history of mental illness and any other diseases or physical conditions that may affect the results of the study;
- Acute chronic bacterial infection within 3 months before enrollment; At the time of enrollment, any symptoms, signs or abnormal laboratory examination suggested the possibility of acute or subacute infection (such as fever, cough, urination, pain, abdominal pain, diarrhea, skin infection, wound, etc.);
- Those who had undergone major surgical operations (craniotomy or thoracotomy) within 4 weeks prior to enrollment, or planned to undergo surgery during the study period, and had unhealed wounds, ulcers or fractures;
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- Patients with herpes zoster remission less than 2 months before enrollment;
- Physical examination or ecg reveals abnormal vital signs: heart rate \< 50 beats/min or > 100 times/min (at least 5 minutes after resting), systolic pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg, or postural hypotension, body temperature (axillary temperature) 37.3;
- Blood routine examination: White blood cell (WBC)\& LT; 3.0 109 / L or \& gt; 9.5 109/L, neutrophils \< 1.5 109/L, platelet \< 100 109/L; Hemoglobin \& Lt; 130g/L(male) or \< 110 g/L (women); Bilirubin \& gt; 1.2 times normal upper limit, serum creatinine \& GT; Upper normal value; AST\> Upper limit of normal,ALT\> Upper limit of normal;
- Subjects at risk for tuberculosis (TB) :1) have a history of active TB infection; 2) Tuberculin test positive; 3) Radiological examination indicated past tuberculosis infection;
- Hiv-ab HCV-AB HBsAg syphilis test results of either positive;
- Persons with a history of drug or alcohol abuse or positive urine drug screening within 6 months prior to screening;
- Those who donated blood within 3 months before enrollment or planned to donate blood during the study period and 1 month after the study ended;
- Patients who had received blood transfusion within 4 weeks prior to enrollment;
- Subjects who were smokers (who had smoked for more than 6 months prior to screening and smoked more than 5 cigarettes per day), consumed 3 cups of coffee or other caffeine-containing beverages, or 5 cups of tea per day;
- Prior to screening, use of any prescription over-the-counter drug or herbal medicine with an estimated time of less than 5 half-life of the drug or less than 14 days prior to initial administration, whichever is the longest;
- Those who received vaccination or immunotherapy within 3 months prior to screening; Those who plan to receive the vaccine during the study period or within 3 months of discontinuing the drug;
- Patients who cannot tolerate venipunctures and have a history of needle sickness and blood sickness;
- Participants who participated in any drug clinical trials within 3 months prior to enrollment, or who plan to participate in other drug clinical trials during the study period;
- The investigator considered that participants were not eligible to participate in the clinical trial for other reasons.
Trial locations and contacts
1 site in 1 country.
Yi Fang, Phd contact
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Yi Fang, Phd
About this study
Official title: a Single-Center, Randomized, Double-Blind, Does-Escalation Phase I Clinical Study to Evaluate the Tolerability, Safety, PK Characteristics of Recombinant Humanized CTLA-4-FC Fusion Protein Injection in Healthy Subjects.
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.
Read the detailed description
This study adopts a single-center,randomized, double-blind, does-escalation, placebo-controlled design.
There are five dose levels of 1mg/kg, 2.5mg/kg, 5mg/kg, 7.5mg/kg and10mg/kg. 2 of 4 subjects in the 1mg/kg dose group receive the test drug and two receive a placebo. 4 of 6 subjects in the 2.5mg/kg dose group receive the test drug and two receive a placebo. 10 of 12 subjects in the 5mg/kg dose group receive the test drug and two receive a placebo. 10 of 12 subjects in the 7.5mg/kg dose group receive the test drug and two receive a placebo. 10 of 12 subjects in the 10mg/kg dose group receive the test drug and two receive a placebo. Subjects are randomly assigned to receive intravenous administration of the test drug or placebo.
The next higher dose group could be initiated only if the stopping rules is not met which are determined by investigator.
- Conditions
- Health Volunteer
- Being tested
- Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg, Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg, Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg, Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg, Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human CTLA-4-FC fusion protein for injection 1mg/kgBiological
Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg , i.v. single dose usage.
Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kgBiological
Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg , i.v. single dose usage.
Recombinant human CTLA-4-FC fusion protein for injection 5mg/kgBiological
Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg , i.v. single dose usage.
Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kgBiological
Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg , i.v. single dose usage.
Recombinant human CTLA-4-FC fusion protein for injection 10mg/kgBiological
Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg , i.v. single dose usage.
Placebo-1mg/kgBiological
Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg
Placebo-2.5mg/kgBiological
Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg
Placebo-5mg/kgBiological
Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg
Placebo-7.5mg/kgBiological
Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg
Placebo-10mg/kgBiological
Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg | Experimental | Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg single dose usage Receives: Biological: Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg |
| Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg | Experimental | Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg single dose usage Receives: Biological: Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg |
| Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg | Experimental | Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg single dose usage Receives: Biological: Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg |
| Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg | Experimental | Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg single dose usage Receives: Biological: Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg |
| Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg | Experimental | Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg single dose usage Receives: Biological: Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg |
| Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg | Placebo comparator | Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg , i.v. single dose usage. Receives: Biological: Placebo-1mg/kg |
| Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg | Placebo comparator | Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg, i.v. single dose usage. Receives: Biological: Placebo-2.5mg/kg |
| Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg | Placebo comparator | Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg , i.v. single dose usage. Receives: Biological: Placebo-5mg/kg |
| Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg | Placebo comparator | Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg , i.v. single dose usage. Receives: Biological: Placebo-7.5mg/kg |
| Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg | Placebo comparator | Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg , i.v. single dose usage. Receives: Biological: Placebo-10mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by subjects with adverse events
The number of occurrences and incidence are calculated with vital signs, Electrocardiograms, physical examinations, laboratory tests
Measured: First dose up to last follow-up visit （85 days after administration）
Secondary outcomes (4)
Peak concentration (Cmax)
Maximum plasma concentration (Cmax) of CTLA-4-FC fusion protein
Measured: First dose up to last follow-up visit(Day1-Day85）
Peak time (Tmax)
Time required to reach peak concentration after administration of CTLA-4-FC fusion protein
Measured: First dose up to last follow-up visit(Day1-Day85）
Area under the Curve (AUC)
Time required to reach peak concentration after administration of CTLA-4-FC fusion protein
Measured: First dose up to last follow-up visit(Day1-Day85）
Analysis of immunogenicity
The number and positive percentage of anti-drug antibody(ADA) and Neutralizing Antibody(NAb) in different dose groups (experimental drug group and placebo group) were calculated
Measured: First dose up to last follow-up visit（Day1-Day85）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start21 Sep 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health VolunteerStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing VDJBio Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huiying Rao, M.D., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256719
- Sponsor's protocol ID
- VDJ-002-I
- Status last verified
- May 2024
- First submitted
- 21 Dec 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Single-Center, Randomized, Double-Blind, Does-Escalation Phase I Clinical Study to Evaluate the Tolerability, Safety, PK Characteristics of Recombinant Humanized CTLA-4-FC Fusion Protein Injection in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT05256719
- Acronym / sponsor ID
- VDJ-002-I
- Conditions
- Health Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Beijing VDJBio Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Feb 2022 (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 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.
Detailed description
This study adopts a single-center,randomized, double-blind, does-escalation, placebo-controlled design.
There are five dose levels of 1mg/kg, 2.5mg/kg, 5mg/kg, 7.5mg/kg and10mg/kg. 2 of 4 subjects in the 1mg/kg dose group receive the test drug and two receive a placebo. 4 of 6 subjects in the 2.5mg/kg dose group receive the test drug and two receive a placebo. 10 of 12 subjects in the 5mg/kg dose group receive the test drug and two receive a placebo. 10 of 12 subjects in the 7.5mg/kg dose group receive the test drug and two receive a placebo. 10 of 12 subjects in the 10mg/kg dose group receive the test drug and two receive a placebo. Subjects are randomly assigned to receive intravenous administration of the test drug or placebo.
The next higher dose group could be initiated only if the stopping rules is not met which are determined by investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg | Experimental | Biological: Recombinant human CTLA-4-FC fusion protein for injection 1mg/kgRecombinant human CTLA-4-FC fusion protein for injection 1mg/kg single dose usage |
| Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg | Experimental | Biological: Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kgRecombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg single dose usage |
| Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg | Experimental | Biological: Recombinant human CTLA-4-FC fusion protein for injection 5mg/kgRecombinant human CTLA-4-FC fusion protein for injection 5mg/kg single dose usage |
| Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg | Experimental | Biological: Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kgRecombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg single dose usage |
| Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg | Experimental | Biological: Recombinant human CTLA-4-FC fusion protein for injection 10mg/kgRecombinant human CTLA-4-FC fusion protein for injection 10mg/kg single dose usage |
| Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg | Placebo comparator | Biological: Placebo-1mg/kgRecombinant human CTLA-4-FC fusion protein for injection 1mg/kg , i.v. single dose usage. |
| Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg | Placebo comparator | Biological: Placebo-2.5mg/kgRecombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg, i.v. single dose usage. |
| Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg | Placebo comparator | Biological: Placebo-5mg/kgRecombinant human CTLA-4-FC fusion protein for injection 5mg/kg , i.v. single dose usage. |
| Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg | Placebo comparator | Biological: Placebo-7.5mg/kgRecombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg , i.v. single dose usage. |
| Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg | Placebo comparator | Biological: Placebo-10mg/kgRecombinant human CTLA-4-FC fusion protein for injection 10mg/kg , i.v. single dose usage. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- For healthy subjects, health was defined as no abnormality or no abnormality of clinical significance during the screening period, such as medical history, physical examination, electrocardiogram, imaging, and laboratory results;
- Male or female subjects, between 18 and 45 years old (including boundary values);
- Male subjects should weigh no less than 50.0 kg and female subjects should weigh no less than 45.0 kg. Body mass index (BMI) between 19.0 and 25.0 kg/m2 (including critical value),BMI= weight (kg)/ height 2(m2);
- Women of reproductive age must use a reliable method of contraception to avoid pregnancy throughout the study period, 4 weeks prior to administration and 3 months after the end of the study, and fertile men must use a reliable method of contraception to avoid pregnancy during the study period and 3 months after the end of the study;
- Subjects voluntarily participated in the study and signed informed consent.
Key exclusion criteria (20 listed)
- Allergic disposition, known or suspected allergy to the test drug or any excipients (disodium hydrogen phosphate and mannitol) or allergy to alcohol/iodine (or iodophor)/ heparin or a history of allergy to any drug, food or pollen, or abnormal serum immunoglobulin E(IgE) tests, conforming to any of these conditions;
- Have a fertility plan or sperm/egg donation plan during the study period and within 3 months after the study; Female subjects have positive urine/blood pregnancy test at baseline, or are lactating;
- Female subjects who took oral contraceptives 30 days before and during the trial, or who used long-acting estrogen or progesterone injections or implants 6 months before and during the trial;
- Patients with central nervous system, cardiovascular system, liver and kidney dysfunction, digestive system, respiratory system and skeletal system diseases (including but not limited to arrhythmia, bradycardia, hypotension, coronary heart disease, bronchial asthma, diabetes, hyperthyroidism, Parkinson's disease, epilepsy, paralysis tremor) Or a history of mental illness and any other diseases or physical conditions that may affect the results of the study;
- Acute chronic bacterial infection within 3 months before enrollment; At the time of enrollment, any symptoms, signs or abnormal laboratory examination suggested the possibility of acute or subacute infection (such as fever, cough, urination, pain, abdominal pain, diarrhea, skin infection, wound, etc.);
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 |
|---|---|---|
| Recombinant human CTLA-4-FC fusion protein for injection 1mg/kgRecombinant human CTLA-4-FC fusion protein for injection 1mg/kg , i.v. single dose usage. | Biological | Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg |
| Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kgRecombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg , i.v. single dose usage. | Biological | Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg |
| Recombinant human CTLA-4-FC fusion protein for injection 5mg/kgRecombinant human CTLA-4-FC fusion protein for injection 5mg/kg , i.v. single dose usage. | Biological | Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg |
| Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kgRecombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg , i.v. single dose usage. | Biological | Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg |
| Recombinant human CTLA-4-FC fusion protein for injection 10mg/kgRecombinant human CTLA-4-FC fusion protein for injection 10mg/kg , i.v. single dose usage. | Biological | Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg |
| Placebo-1mg/kgRecombinant human CTLA-4-FC fusion protein for injection 1mg/kg | Biological | Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg |
| Placebo-2.5mg/kgRecombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg | Biological | Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg |
| Placebo-5mg/kgRecombinant human CTLA-4-FC fusion protein for injection 5mg/kg | Biological | Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg |
| Placebo-7.5mg/kgRecombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg | Biological | Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg |
| Placebo-10mg/kgRecombinant human CTLA-4-FC fusion protein for injection 10mg/kg | Biological | Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg |
Primary outcome
Safety as measured by subjects with adverse events
Time frame: First dose up to last follow-up visit （85 days after administration）
The number of occurrences and incidence are calculated with vital signs, Electrocardiograms, physical examinations, laboratory tests
4 secondary outcomes
Peak concentration (Cmax)
Time frame: First dose up to last follow-up visit(Day1-Day85）
Peak time (Tmax)
Time frame: First dose up to last follow-up visit(Day1-Day85）
Area under the Curve (AUC)
Time frame: First dose up to last follow-up visit(Day1-Day85）
Analysis of immunogenicity
Time frame: First dose up to last follow-up visit（Day1-Day85）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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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.
Yi Fang, Phd contact
Huiying Rao, M.D. principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg, Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg and Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg in people with Health Volunteer, run by Beijing VDJBio Co., LTD. at 1 site 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 5 inclusion and 20 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 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 Xiaoming Gong, Msc (+8613811280880, gxm@vdjbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as measured by subjects with adverse events (time frame: First dose up to last follow-up visit （85 days after administration）). 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 7 May 2024.