TuberculosisPhase 1NCT06224608
Phase I Clinical Trial to Evaluate the Safety of Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in Healthy Adults Aged 18-65 and Patients With Pulmonary Tuberculosis
A Phase 1 study testing Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in people with Tuberculosis, run by Chengdu CoenBiotech Co., Ltd at 2 sites in China.
Trial summary
The study is to enroll 60 participants aged 18-65 years old, including 30 healthy subjects and 30 tuberculosis patients. Low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) studies will be conducted separately for healthy subjects and pulmonary tuberculosis patients, with 20 participants in each… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 17 Jan 2023to 9 May 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For healthy participants：
- Age 18 to 65 years old (including 18 and 65), both males and females are eligible;
- Willing to participate in the trial and sign an informed consent form;
- Able to comply with the requirements of the clinical trial protocol and participate in follow-up;
- No history of tuberculosis (including pulmonary and extrapulmonary tuberculosis), no family history of tuberculosis (in direct relatives), and no history of close contact with tuberculosis patients (referring to direct contact with registered tuberculosis patients within 3 months before their diagnosis or within 14 days after starting anti-tuberculosis treatment);
- No clinical symptoms of tuberculosis poisoning; chest X-ray examination is normal or abnormal but has no clinical significance; vital signs: body temperature (axillary temperature) <37.3℃, blood pressure (systolic pressure <140mmHg, diastolic pressure <90mmHg), pulse 50~100 times/min, electrocardiogram, physical examination is normal or abnormal but has no clinical significance;
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- Laboratory tests including blood routine, urine routine, and blood biochemistry are normal or abnormal but have no clinical significance;
- Female participants of childbearing age must have a negative pregnancy test before enrollment and have no plans to conceive within 28 days after enrollment, and promise to take effective contraceptive measures (including: oral contraceptives, injection or implantation of contraceptives, slow-release local contraceptives, hormonal patches, intrauterine devices (IUD), sterilization, avoidance of sexual activity, condoms (male), diaphragms, cervical caps, etc.; contraceptive methods such as safe period contraception, coitus interruptus, and emergency contraception are not considered effective).
- For patients with pulmonary tuberculosis
- Diagnosed as pulmonary tuberculosis according to the "Diagnostic Criteria for Pulmonary Tuberculosis in the Health Industry Standard of the People's Republic of China (WS288-2017)" (recognized clinical diagnosis made through comprehensive analysis);
- Aged 18 to 65 years old (including 18 and 65), regardless of gender;
- Willing to participate in this trial and sign an informed consent form;
- Able to comply with the requirements of the clinical trial protocol and participate in follow-up visits;
- Women of childbearing age must have a negative pregnancy test before enrollment, have no plans to conceive within 28 days after enrollment, and commit to using effective contraception (including oral contraceptives, injection or implantation of contraceptives, slow-release local contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, avoiding sexual activity, male condoms, diaphragms, cervical caps, etc.; ineffective contraceptive measures include the safe period method, withdrawal method, and emergency contraception, etc.)
Who cannot join
- Known or suspected (or with a high risk of occurrence) immune dysfunction or abnormalities, including : ①Patients receiving immunosuppressive agents (including chemotherapy) or immunostimulants;②Patients who have received immunoglobulin preparations or blood products or plasma extraction treatment within the past 3 months;③Patients with malignant tumors, AIDS, etc.;
- History of seizures, epilepsy, or psychiatric illness and/or family history of psychiatric illness (first-degree relatives);
- Allergic constitution, such as a history of allergies to two or more drugs or foods, or known allergies to the components of the drug or a keloid-prone constitution;
- Currently suffering from acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute conjunctivitis, acute otitis media, or widespread skin diseases;
- Past or present history of severe cardiovascular, liver, kidney, gastrointestinal, neurological, psychiatric or metabolic abnormalities, etc., as determined by questioning;
- Acute febrile illness;
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- Severe infection (such as pyoderma, severe eczema, etc.);
- Currently participating or having participated in any other new drug clinical trial within the past 3 months;
- Pregnant or lactating women;
- Drug abusers or alcoholics;
- Any other situation that the researcher believes may affect the evaluation of the trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149
About this study
Official title: Phase I Clinical Trial to Evaluate the Safety and Tolerability of Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in Healthy Adults Aged 18-65 and Patients With Pulmonary Tuberculosis
The study is to enroll 60 participants aged 18-65 years old, including 30 healthy subjects and 30 tuberculosis patients. Low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) studies will be conducted separately for healthy subjects and pulmonary tuberculosis patients, with 20 participants in each dosage group. Within 28 days after the skin test of the test drug, observations were made of reactions at the skin test site, reactions at non-skin test sites, concomitant medication, and any other physical discomfort (skin test site-specific reactions were recorded separately).
Read the detailed description
The study is to enroll 60 participants aged 18-65 years old, including 30 healthy subjects and 30 tuberculosis patients. Low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) studies will be conducted separately for healthy subjects and pulmonary tuberculosis patients, with 20 participants in each dosage group.
Enrollment will progress from low to high dosages, first with healthy subjects and then with pulmonary tuberculosis patients. The safety review committee (SRC) will review safety data before each dosage group escalates and before enrollment of tuberculosis patients. See the figure below for details.
First, 10 healthy subjects will be enrolled in the low-dose group. After confirming the safety of the test drug within 72 hours of the skin test for all participants, the medium-dose group (10 participants) will be enrolled. After confirming the safety of the test drug within 72 hours of the skin test for all participants, the high-dose group (10 participants) will be enrolled. Participants will receive a single intradermal injection of 0.1 ml of the test drug using the Mantoux method on the volar aspect of the forearm.After the last healthy subject in the low-dose group completes the 72-hour safety assessment following the skin test, pulmonary tuberculosis patients in the low-dose group can be enrolled simultaneously.
Ten pulmonary tuberculosis patients will be enrolled in the low-dose group. After confirming the safety of the test drug within 72 hours of the skin test for all participants, the medium-dose group (10 participants) will be enrolled. After confirming the safety of the test drug within 72 hours of injection for all participants, the high-dose group (10 participants) will be enrolled. Participants will receive a single intradermal injection of 0.1 ml of the test drug using the Mantoux method on the volar aspect of the forearm.
Within 28 days after the skin test of the test drug, observations were made of reactions at the skin test site, reactions at non-skin test sites, concomitant medication, and any other physical discomfort (skin test site-specific reactions were recorded separately).
- Conditions
- Tuberculosis
- Being tested
- Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC)
- Keywords
- Tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC)Biological
1.0ml/bottle, containing 2.5μg/ml low dose, 5μg/ml medium dose, and 10μg/ml high dose of active ingredient.
Take 0.1ml and inject it into the center of the front 1/3 of the palm side of the forearm by the Montessori method Single dose administration.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary tuberculosis patients | Experimental | Experimental drug of low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) will be conducted separately for 30 Pulmonary tuberculosis patients aged 18-65 years old ，each dose for10 cases. Receives: Biological: Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) |
| Healthy subjects | Experimental | Experimental drug of low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) will be conducted separately for 30 healthy subjects aged 18-65 years old ，each dose for10 cases. Receives: Biological: Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) at the skin test site and non-skin test site within 28 days after skin testing, with particular attention to the incidence of AEs within 7 days after skin testing.
Measured: 28 days after injection
Incidence of abnormal blood routine, blood biochemistry, urine routine, and electrocardiogram detection indexes on the 3rd day after skin testing.
Measured: 3 days after injection
Incidence of abnormal vital signs within 7 days after skin testing.
Measured: 7 days after injection
Incidence of serious adverse events (SAEs) within 28 days after skin testing.
Measured: 28 days after injection
Secondary outcomes (3)
Specific skin reactions at the skin test site at 30 minutes, 2 hours, 4 , 8 , 24 , 48 , 72 , 96 hours, and 7 days after skin testing for different doses of EEC.
Measured: 7 days after injection
Agreement between skin test results and IGRA test results for different doses of EEC.
Measured: 7 days after injection
Agreement between IGRA test results before and after skin testing.
Measured: 7 days after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start17 Jan 2023
- Primary completion9 May 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu CoenBiotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Chest Hospital, Capital Medical University, Beijing Friendship Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224608
- Sponsor's protocol ID
- KN-EEC-I
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 25 Jan 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 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Safety and Tolerability of Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in Healthy Adults Aged 18-65 and Patients With Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT06224608
- Acronym / sponsor ID
- KN-EEC-I
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chengdu CoenBiotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Chest Hospital, Capital Medical University, Beijing Friendship Hospital
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 25 Jan 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.
The study is to enroll 60 participants aged 18-65 years old, including 30 healthy subjects and 30 tuberculosis patients. Low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) studies will be conducted separately for healthy subjects and pulmonary tuberculosis patients, with 20 participants in each dosage group. Within 28 days after the skin test of the test drug, observations were made of reactions at the skin test site, reactions at non-skin test sites, concomitant medication, and any other physical discomfort (skin test site-specific reactions were recorded separately).
Detailed description
The study is to enroll 60 participants aged 18-65 years old, including 30 healthy subjects and 30 tuberculosis patients. Low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) studies will be conducted separately for healthy subjects and pulmonary tuberculosis patients, with 20 participants in each dosage group.
Enrollment will progress from low to high dosages, first with healthy subjects and then with pulmonary tuberculosis patients. The safety review committee (SRC) will review safety data before each dosage group escalates and before enrollment of tuberculosis patients. See the figure below for details.
First, 10 healthy subjects will be enrolled in the low-dose group. After confirming the safety of the test drug within 72 hours of the skin test for all participants, the medium-dose group (10 participants) will be enrolled. After confirming the safety of the test drug within 72 hours of the skin test for all participants, the high-dose group (10 participants) will be enrolled. Participants will receive a single intradermal injection of 0.1 ml of the test drug using the Mantoux method on the volar aspect of the forearm.After the last healthy subject in the low-dose group completes the 72-hour safety assessment following the skin test, pulmonary tuberculosis patients in the low-dose group can be enrolled simultaneously.
Ten pulmonary tuberculosis patients will be enrolled in the low-dose group. After confirming the safety of the test drug within 72 hours of the skin test for all participants, the medium-dose group (10 participants) will be enrolled. After confirming the safety of the test drug within 72 hours of injection for all participants, the high-dose group (10 participants) will be enrolled. Participants will receive a single intradermal injection of 0.1 ml of the test drug using the Mantoux method on the volar aspect of the forearm.
Within 28 days after the skin test of the test drug, observations were made of reactions at the skin test site, reactions at non-skin test sites, concomitant medication, and any other physical discomfort (skin test site-specific reactions were recorded separately).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary tuberculosis patients | Experimental | Biological: Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC)Experimental drug of low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) will be conducted separately for 30 Pulmonary tuberculosis patients aged 18-65 years old ，each dose for10 cases. |
| Healthy subjects | Experimental | Biological: Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC)Experimental drug of low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) will be conducted separately for 30 healthy subjects aged 18-65 years old ，each dose for10 cases. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- For healthy participants：
- For patients with pulmonary tuberculosis
Key exclusion criteria (11 listed)
- Known or suspected (or with a high risk of occurrence) immune dysfunction or abnormalities, including : ①Patients receiving immunosuppressive agents (including chemotherapy) or immunostimulants;②Patients who have received immunoglobulin preparations or blood products or plasma extraction treatment within the past 3 months;③Patients with malignant tumors, AIDS, etc.;
- History of seizures, epilepsy, or psychiatric illness and/or family history of psychiatric illness (first-degree relatives);
- Allergic constitution, such as a history of allergies to two or more drugs or foods, or known allergies to the components of the drug or a keloid-prone constitution;
- Currently suffering from acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute conjunctivitis, acute otitis media, or widespread skin diseases;
- Past or present history of severe cardiovascular, liver, kidney, gastrointestinal, neurological, psychiatric or metabolic abnormalities, etc., as determined by questioning;
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 Mycobacterium Tuberculosis Fusion Protein (EEC)1.0ml/bottle, containing 2.5μg/ml low dose, 5μg/ml medium dose, and 10μg/ml high dose of active ingredient. Take 0.1ml and inject it into the center of the front 1/3 of the palm side of the forearm by the Montessori method Single dose administration. | Biological | Healthy subjects, Pulmonary tuberculosis patients |
Primary outcome
Incidence of adverse events (AEs) at the skin test site and non-skin test site within 28 days after skin testing, with particular attention to the incidence of AEs within 7 days after skin testing.
Time frame: 28 days after injection
Incidence of abnormal blood routine, blood biochemistry, urine routine, and electrocardiogram detection indexes on the 3rd day after skin testing.
Time frame: 3 days after injection
Incidence of abnormal vital signs within 7 days after skin testing.
Time frame: 7 days after injection
Incidence of serious adverse events (SAEs) within 28 days after skin testing.
Time frame: 28 days after injection
3 secondary outcomes
Specific skin reactions at the skin test site at 30 minutes, 2 hours, 4 , 8 , 24 , 48 , 72 , 96 hours, and 7 days after skin testing for different doses of EEC.
Time frame: 7 days after injection
Agreement between skin test results and IGRA test results for different doses of EEC.
Time frame: 7 days after injection
Agreement between IGRA test results before and after skin testing.
Time frame: 7 days after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in people with Tuberculosis, run by Chengdu CoenBiotech Co., Ltd at 2 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 14 inclusion and 11 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: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) at the skin test site and non-skin test site within 28 days after skin testing, with particular attention to the incidence of AEs within 7 days after skin testing. (time frame: 28 days after injection). The study lists 4 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 25 Jan 2024.