Clostridium TetanusEarly Phase 1NCT06360250
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination Formulation
A Early Phase 1 study testing Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation, Tetanus human immunoglobulin (HTIG) and Adsorbed tetanus vaccine (TT) in people with Clostridium Tetanus, run by Changchun BCHT Biotechnology Co..
Trial summary
To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the full human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination formulation Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Clostridium Tetanus
- What is being tested?
- Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation, Tetanus human immunoglobulin (HTIG) and Adsorbed tetanus vaccine (TT)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2024to 30 Oct 2024
- Phase
- Early 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Before the trial, I have a detailed understanding of the nature, significance and possible benefits of the trial, possible inconvenience and potential risks and discomfort, and volunteered to participate in this clinical trial, be able to communicate well with researchers, comply with the requirements of the whole study, and signed a written informed consent;
- Men or women aged 18~59 (including boundary values) at the time of screening;
- The weight of female volunteers was 45.0 kg, male volunteers were 50.0 kg, and the body mass index (BMI) was between 18.0 and 27.0 kg / m2 (including the boundary value) (BMI= weight kg / height m2);
- female volunteers from the 14 days before the first dose to 3 months after the end of the test and voluntary use at least one acceptable contraceptive method, male volunteers from the first time to the trial within 3 months no fertility or donate sperm plan and voluntary use of at least one acceptable contraceptive method.
Who cannot join
- People who are known to be allergic to experimental drugs (including excipients and similar drugs), or who suffer from severe allergic diseases or allergies (such as allergic to two or more drugs, food or pollen), may damage the safety of the volunteers by the judgment of the investigator (inquiry);
- Those with a clear history of allergy to essential substances (such as skin disinfectants and alcohol substances that may be exposed to) during the test (inquiry);
- tetanus vaccine or tetanus toxin antigen component (DPT vaccine, DPT vaccine, meningitis conjugate vaccine, etc.) vaccinated in the previous 10 years (inquiry);
- Those who received any live attenuated vaccine or inactivated vaccine (including COVID-19 vaccine) within 1 month (30 days) before the first dose, or received the above vaccine within 3 months after the planned dose (inquiry);
- Previous history of tetanus infection (inquiry);
- Known or suspected immune deficiency (inquiry), including immunosuppressive therapy (radiation therapy, chemotherapy, corticosteroid hormones, antimetabolism, cytotoxic drugs) (inquiry, inquiry), HIV infection (inquiry) within 3 months before the first dose (90 days);
Show all 27Show fewer
- History of active infection or disease with one of the following conditions:
- Systemic systemic anti-infective therapy within 14 days before the first administration (inquiry, inquiry); Recurrent, chronic, or other active infections, as assessed by the investigator, may increase the volunteer risk (inquiry).
- Patients with chronic diseases (including hypertension, diabetes, hyperlipidemia, hyperuricemia, etc.) (phase I only); chronic diseases (including hypertension, diabetes, hyperlipidemia, hyperuricemia, etc.) and unstable control (phase II only) (inquiry);
- People with a history of tuberculosis who are not cured or have active tuberculosis infection during screening (inquiry);
- has a history of malignancy (active or has been treated but not clearly clinically cured, or may recur during the trial) (inquiry);
- Patients with a previous history of convulsions, epilepsy, mental or neurological system, or a family history of convulsions or epilepsy (inquiry);
- Those who have a history of clinically serious disease within 6 months before the first dose (180 days) and are not cured, or those who have acute or chronic diseases that may significantly affect the in vivo process or safety evaluation of the investigational drug (inquiry, inquiry);
- Those who had received major surgery within 3 months (90 days) prior to the first dose, or who may have significantly affected the process or safety evaluation of the study drug, or who planned to undergo surgery during the study (inquiry, inquiry);
- Those who have been used or are in significant impact on the in vivo process or safety evaluation of the investigational drug (inquiry, inquiry);
- Use of other clinical trial drugs / devices within 3 months (90 days) prior to the first dose, or <5 clearance half-lives since the last dose of previous experimental drugs (whichever is older), or participation in other clinical trial planners during the trial (inquiry, inquiry);
- Drinking more than 28 units of alcohol per week (1 unit =285 ml beer or 25 ml spirits or 40% alcohol) for 3 months (90 days) before the first dose (inquiry);
- Smoking more than 10 cigarettes or equal amounts of tobacco per day for 1 month (30 days) prior to the first dose (inquiry);
- Blood loss / blood donation over 400 ml (except female physiologic blood loss) within 3 months (90 days) before the first dose, or receiving blood transfusion or using blood products, or planned to donate during the trial or within 1 month (30 days) after the end of the trial (inquiry);
- Patients with positive rapid IgG during the screening period (examination);
- Those with a history of substance abuse (inquiry) or those positive for substance abuse screening during the screening period (examination);
- Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCV-Ab) antibody, Treponema syphilis antibody (TPPA) or antibody to human immunodeficiency virus (Anti-HIV);
- Ear temperature during the screening period is> 37.5℃ (examination);
- Physical examination, vital signs (blood pressure, pulse rate), electrocardiogram, other laboratory tests (laboratory tests not listed separately) or other auxiliary test results during the screening period are judged as abnormal and clinically significant by the study doctor (examination);
- Women in pregnancy or lactation (inquiry) or those with a positive pregnancy test (examination);
- Patients with a history of needle acupuncture, blood halo (inquiry), unable to tolerate or without adequate venous access to allow regular venipuncture (inquiry, examination);
- The volunteers may be unable to cooperate with the study for other reasons or the investigators is not unsuitable for inclusion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Multicenter, Randomized, Blinded, Controlled Phase I / Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination
To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the full human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination formulation
Read the detailed description
Ia (separate administration phase) To evaluate the safety and tolerability of a single intramuscular injection of different doses of CBL8851 injection in healthy adult Chinese volunteers.
- To evaluate the pharmacokinetic characteristics of a single intramuscular injection of different doses of CBL8851 injection in Chinese healthy adult volunteers;
- To evaluate the pharmacodynamic characteristics of a single intramuscular injection of different doses of CBL8851 injection in Chinese healthy adult volunteers;
- To evaluate the immunogenicity characteristics of a single intramuscular injection of different doses of CBL8851 injection in Chinese healthy adult volunteers.
Ib (Drug interaction phase) To evaluate the safety and tolerability of intramuscular CBL8851 injection combined with tetanus vaccine in Chinese healthy adult volunteers.
- To evaluate the pharmacodynamic characteristics of the intramuscular CBL8851 injection combined with the adsorption of tetanus vaccine in Chinese healthy adult volunteers, and to evaluate the drug interaction;
- To evaluate the pharmacokinetic characteristics of intramuscular CBL8851 injection plus tetanus vaccine in Chinese healthy adult volunteers;
- To evaluate the immunogenicity characteristics of intramuscular CBL8851 injection combined with tetanus vaccine in Chinese healthy adult volunteers.
II designated time Compare the neutralizing antibody activity of intramuscular CBL8851 injection and tetanus human immunoglobulin in Chinese adult volunteers to select the best dose for subsequent efficacy confirmatory tests.
- to compare the safety of intramuscular CBL8851 injection with tetanus human immunoglobulin in Chinese adult volunteers;
- To evaluate the immunogenicity characteristics of intramuscular CBL8851 injection in Chinese adult volunteers.
- Conditions
- Clostridium Tetanus
- Being tested
- Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation, Tetanus human immunoglobulin (HTIG), Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placebo, Adsorbed tetanus vaccine (TT)
- Keywords
- Monoclonal antibody to tetanus, Safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparationDrug
Each dose (1.0 ml) contained 1.25 mg of human anti-tetanus toxin monoclonal antibody A82 and 1.25 mg of human anti-tetanus toxin monoclonal antibody B86.
Tetanus human immunoglobulin (HTIG)Drug
Tetanus human immunoglobulin (HTIG)
Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placeboDrug
There were no active ingredients, and other ingredients were the same
Adsorbed tetanus vaccine (TT)Biological
containing tetanus toxoid titer not less than 40 IU
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Each dose (1.0 ml) contained 1.25 mg of fully human anti-tetanus toxin monoclonal antibody A82 and 1.25 mg of fully human anti-tetanus toxin monoclonal antibody B86,2.5 mg (1.0 ml) / vial Receives: Drug: Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation; Biological: Adsorbed tetanus vaccine (TT) |
| Positive control group | Active comparator | Tetanus with human immunoglobulin Receives: Drug: Tetanus human immunoglobulin (HTIG); Biological: Adsorbed tetanus vaccine (TT) |
| Placebo group | Placebo comparator | There were no active ingredients, and other ingredients were the same Receives: Drug: Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placebo; Biological: Adsorbed tetanus vaccine (TT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation index
All observed adverse events, serious adverse events, including but not limited to: Clinical indicators Physical examination; vital signs; 12-lead ECG; local reaction; systemic reaction. Laboratory tests: blood routine, urine routine, blood biochemistry (liver function, kidney function, fasting blood glucose, blood lipid, myocardial enzyme spectrum, electrolytes), blood coagulation routine, blood / urine pregnancy test (only fertility women), etc.; Other auxiliary examinations: chest CT and abdominal B-ultrasound.
Measured: Twelve months
Secondary outcomes (10)
PK evaluation index
Peak Plasma Concentration (Cmax)
Measured: Twelve months
PK evaluation index
Area under the plasma concentration versus time curve (AUC)
Measured: Twelve months
PK evaluation index
Maximum peak time (Tmax)
Measured: Twelve months
PK evaluation index
Half-life period(T1/2)
Measured: Twelve months
PK evaluation index
MeanResidenceTime（MRT）
Measured: Twelve months
PK evaluation index
Apparent clearance rate (CL / F)
Measured: Twelve months
PD evaluation index
The level of neutralizing antibodies against tetanus toxin at 6 h, 12 h, and 24 h, on days 2,3,7,14,21,28,42,56,84, and 105
Measured: Twelve months
PD evaluation index
6 h, 12 h, and 24 h at days 2,1,2,3,7,14,21,28,42,56,84, and 105 (0.01 IU / ml [modified ligand binding assay] or 0.1 IU / ml [direct ligand binding assay])
Measured: Twelve months
PD evaluation index
Duration of 0.01 IU / ml (modified ligand binding assay) or 0.1 IU / ml (direct ligand binding assay) at days 2,3,7,24,21,56,84 and 24 h after administration
Measured: Twelve months
Immunogenicity evaluation index
Positive rate of anti-drug antibody (ADA) and neutralizing antibody (Nab) on days 7,14,28,56, and 105 of CBL8851 injection (CBL8851A82 and CBL8851B86).
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start10 Apr 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium TetanusStudies of the same condition, open and under way.
- More trials run by Changchun BCHT Biotechnology Co.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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, Anning City First People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360250
- Sponsor's protocol ID
- B2001-F20220601
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 11 Apr 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 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Blinded, Controlled Phase I / Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination
- ClinicalTrials.gov ID
- NCT06360250
- Acronym / sponsor ID
- B2001-F20220601
- Conditions
- Clostridium Tetanus
- Keywords
- Monoclonal antibody to tetanus, Safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, Anning City First People's Hospital
- Study start
- 10 Apr 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 11 Apr 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.
To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the full human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination formulation
Detailed description
Ia (separate administration phase) To evaluate the safety and tolerability of a single intramuscular injection of different doses of CBL8851 injection in healthy adult Chinese volunteers.
- To evaluate the pharmacokinetic characteristics of a single intramuscular injection of different doses of CBL8851 injection in Chinese healthy adult volunteers;
- To evaluate the pharmacodynamic characteristics of a single intramuscular injection of different doses of CBL8851 injection in Chinese healthy adult volunteers;
- To evaluate the immunogenicity characteristics of a single intramuscular injection of different doses of CBL8851 injection in Chinese healthy adult volunteers.
Ib (Drug interaction phase) To evaluate the safety and tolerability of intramuscular CBL8851 injection combined with tetanus vaccine in Chinese healthy adult volunteers.
- To evaluate the pharmacodynamic characteristics of the intramuscular CBL8851 injection combined with the adsorption of tetanus vaccine in Chinese healthy adult volunteers, and to evaluate the drug interaction;
- To evaluate the pharmacokinetic characteristics of intramuscular CBL8851 injection plus tetanus vaccine in Chinese healthy adult volunteers;
- To evaluate the immunogenicity characteristics of intramuscular CBL8851 injection combined with tetanus vaccine in Chinese healthy adult volunteers.
II designated time Compare the neutralizing antibody activity of intramuscular CBL8851 injection and tetanus human immunoglobulin in Chinese adult volunteers to select the best dose for subsequent efficacy confirmatory tests.
- to compare the safety of intramuscular CBL8851 injection with tetanus human immunoglobulin in Chinese adult volunteers;
- To evaluate the immunogenicity characteristics of intramuscular CBL8851 injection in Chinese adult volunteers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation, Biological: Adsorbed tetanus vaccine (TT)Each dose (1.0 ml) contained 1.25 mg of fully human anti-tetanus toxin monoclonal antibody A82 and 1.25 mg of fully human anti-tetanus toxin monoclonal antibody B86,2.5 mg (1.0 ml) / vial |
| Positive control group | Active comparator | Drug: Tetanus human immunoglobulin (HTIG), Biological: Adsorbed tetanus vaccine (TT)Tetanus with human immunoglobulin |
| Placebo group | Placebo comparator | Drug: Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placebo, Biological: Adsorbed tetanus vaccine (TT)There were no active ingredients, and other ingredients were the same |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Before the trial, I have a detailed understanding of the nature, significance and possible benefits of the trial, possible inconvenience and potential risks and discomfort, and volunteered to participate in this clinical trial, be able to communicate well with researchers, comply with the requirements of the whole study, and signed a written informed consent;
- Men or women aged 18~59 (including boundary values) at the time of screening;
- The weight of female volunteers was 45.0 kg, male volunteers were 50.0 kg, and the body mass index (BMI) was between 18.0 and 27.0 kg / m2 (including the boundary value) (BMI= weight kg / height m2);
- female volunteers from the 14 days before the first dose to 3 months after the end of the test and voluntary use at least one acceptable contraceptive method, male volunteers from the first time to the trial within 3 months no fertility or donate sperm plan and voluntary use of at least one acceptable contraceptive method.
Key exclusion criteria (27 listed)
- People who are known to be allergic to experimental drugs (including excipients and similar drugs), or who suffer from severe allergic diseases or allergies (such as allergic to two or more drugs, food or pollen), may damage the safety of the volunteers by the judgment of the investigator (inquiry);
- Those with a clear history of allergy to essential substances (such as skin disinfectants and alcohol substances that may be exposed to) during the test (inquiry);
- tetanus vaccine or tetanus toxin antigen component (DPT vaccine, DPT vaccine, meningitis conjugate vaccine, etc.) vaccinated in the previous 10 years (inquiry);
- Those who received any live attenuated vaccine or inactivated vaccine (including COVID-19 vaccine) within 1 month (30 days) before the first dose, or received the above vaccine within 3 months after the planned dose (inquiry);
- Previous history of tetanus infection (inquiry);
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 |
|---|---|---|
| Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparationEach dose (1.0 ml) contained 1.25 mg of human anti-tetanus toxin monoclonal antibody A82 and 1.25 mg of human anti-tetanus toxin monoclonal antibody B86. | Drug | Experimental group |
| Tetanus human immunoglobulin (HTIG)Tetanus human immunoglobulin (HTIG) | Drug | Positive control group |
| Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placeboThere were no active ingredients, and other ingredients were the same | Drug | Placebo group |
| Adsorbed tetanus vaccine (TT)containing tetanus toxoid titer not less than 40 IU | Biological | Experimental group, Placebo group, Positive control group |
Primary outcome
Safety evaluation index
Time frame: Twelve months
All observed adverse events, serious adverse events, including but not limited to: Clinical indicators Physical examination; vital signs; 12-lead ECG; local reaction; systemic reaction. Laboratory tests: blood routine, urine routine, blood biochemistry (liver function, kidney function, fasting blood glucose, blood lipid, myocardial enzyme spectrum, electrolytes), blood coagulation routine, blood / urine pregnancy test (only fertility women), etc.; Other auxiliary examinations: chest CT and abdominal B-ultrasound.
10 secondary outcomes
PK evaluation index
Time frame: Twelve months
PK evaluation index
Time frame: Twelve months
PK evaluation index
Time frame: Twelve months
PK evaluation index
Time frame: Twelve months
PK evaluation index
Time frame: Twelve months
PK evaluation index
Time frame: Twelve months
PD evaluation index
Time frame: Twelve months
PD evaluation index
Time frame: Twelve months
PD evaluation index
Time frame: Twelve months
Immunogenicity evaluation index
Time frame: Twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
Related trials for Clostridium Tetanus
RecruitingPhase 1
Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingObservational study
Tetanus Severity Score for Prediction of Mortality in Manifest Tetanus
Tetanus, Manifest
Active, not recruitingPhase 1
Phase I Clinical Trial of Adsorbed Tetanus Vaccine
Tetanus
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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation, Tetanus human immunoglobulin (HTIG) and Adsorbed tetanus vaccine (TT) in people with Clostridium Tetanus, run by Changchun BCHT Biotechnology Co..
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 27 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 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Jianchang HJC He (China：+86-6363-6790, hejc@yn-cprc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation index (time frame: Twelve months). 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 11 Apr 2024.