Cardiac InsufficiencyEarly Phase 1NCT06884111
Safety and Preliminary Efficacy Study of EE001 in Health/Patients Adults with Mild, Moderate, or Severe (NYHA II-IV) Cardiac Insufficiency
A Early Phase 1 study testing EE001，70-105ml per day by IV in people with Cardiac Insufficiency, run by Anhui HygeianCells BioMedical Co., Ltd. at 1 site in China.
Trial summary
This study is a single-center, randomized, open, exploratory, drug-safety IIT study of EE001 in normal adults/patients with mild, moderate, or severe (grades II-IV) cardiac insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Insufficiency
- What is being tested?
- EE001，70-105ml per day by IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2024to 11 Dec 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) Male and female subjects between 18 and 75 years of age (including upper and lower limits).
- Body Mass Index (BMI) between 19 and 28 kg/m2 (including upper and lower limits).
- Sperm and egg donation is prohibited during the study period (from signing of the Informed Consent Form to the final follow-up visit) and within 90 days of the final dose of study medication, and there is no likelihood of conception (or impregnation of a sexual partner), childbearing, or breastfeeding.
- No history of major medical problems, and there are no medical conditions during the screening period that may have contributed to the study.
- no history of major diseases, and the results of physical examination, vital signs and laboratory tests during the screening period are normal, or out of the normal reference range but not clinically significant in the judgment of the investigator.
- The ability to communicate with clinical staff and comply with the requirements of the study.
- Signing the informed consent form to indicate their willingness to participate in the study.
Who cannot join
- The presence of a medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the drug or that may interfere with adherence to the study protocol.
- Have history of hemophilia or coagulation disorders.
- Diagnosed with of endocrine, neurological, hematological, immunological (including hereditary immune deficiencies by personal or family history), psychiatric, metabolic abnormalities, lymphoproliferative disorders, severe or opportunistic infections (including herpes, tuberculosis) that in the opinion of the investigator are still clinically significant.
- Allergies, particularly to eggs or chicken.
- Participation in other clinical studies within 90 days prior to the first application of the investigational product.
- Discontinuation of other, what in the opinion of the investigator, affects the results of the evaluation of this study, prior to the first application of the investigational product prescription or over-the-counter medication for less than 14 days or 5 half-lives of that medication (whichever is longer).
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- With history of malignancy within the past 5 years.
- Having donated blood or lost a significant amount of blood (>400 mL) within 90 days prior to the first use of the investigational product.
- Having undergone major surgery (as determined by the investigator based on past medical history information) or having suffered major trauma.
- Subjects with abnormal vital sign measurements that are clinically significant in the judgment of the investigator.
- Clinical or laboratory evidence of the presence of one of the following: Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), or syphilis carriage/infection.
- With severe renal disease.
- Difficulty with intravenous blood collection or known history of multiple episodes of needle or blood sickness.
- Have history of regular alcohol consumption in the 6 months prior to screening, more than 14 drinks/week (1 drink = 5 oz wine or 12 oz beer or 1.5 oz spirits) in males, or exceeding the alcohol test limit during the Screening Period; who have taken any alcohol-containing product within 48 hours prior to the first use of the investigational product or who do not agree to avoid any alcohol-containing product during the trial period;
- Poor compliance and unwillingness to comply with study requirements.
Trial locations and contacts
1 site in 1 country.
China1 site
AnHui Hygeiancells BioMedical Co., Ltd.
Huangshan City, Anhui, 245000
About this study
Official title: Single-Center, Randomized, Open, Exploratory, Drug Safety IIT Study of EE001 in Normal Adults/Patients with Mild, Moderate, or Severe (NYHA II-IV) Cardiac Insufficiency
This study is a single-center, randomized, open, exploratory, drug-safety IIT study of EE001 in normal adults/patients with mild, moderate, or severe (grades II-IV) cardiac insufficiency. Primary aims of this study is to assess the safety and tolerability of EE001 in normal adults and patients with mild, moderate, or severe (Class II-IV) cardiac insufficiency after single and consecutive repeated doses, and to carry out a preliminary evaluation of the pharmacodynamic indexes, to understand the preliminary efficacy of the drug in applied indications. The Secondary objectives are:
- To observe the effect of EE001 on cardiac ejection index (color echocardiography) in normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency;
- To preliminarily evaluate the effect of EE001 on the cardiac functions of normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency, in accordance with the comprehensive criteria of cardiac function index.
- Six-minute walk test: to preliminarily assess the effect of EE001 on the exercise status of normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency;
- to assess the effect of EE001 on the serum levels of BNP and cardiac enzyme profiles of subjects after administration of EE001 to normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency;
- to evaluate the effect of EE001 on changes in human cytokine levels (IL-1, IL-6, IL-10, TNF-α, etc.) in normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency; and
- to evaluate the effect of EE001 on changes in the number of regulatory T cells in normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency.
- Conditions
- Cardiac Insufficiency
- Being tested
- EE001，70-105ml per day by IV
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EE001，70-105ml per day by IVDrug
EE001 is a brand-new testing agent for human studies, it is the first time in human being
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: EE001，70-105ml per day by IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment
General toxicities and safe pharmacology properties of EE001 to human body at the applied dosage procedure will be assessed at different time point.
Measured: Baseline, Day 1, Day7
Secondary outcomes (1)
Efficacy assessment
The preliminary efficacy of EE001 on cardiac ejection index (color echocardiography) at the applied administration schedule will be determined.
Measured: Baseline, Day1, Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start5 Jun 2024
- Primary completion11 Dec 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac InsufficiencyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui HygeianCells BioMedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884111
- Sponsor's protocol ID
- AHHCEE001CSP001
- Status last verified
- Apr 2024
- First submitted
- 6 Feb 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center, Randomized, Open, Exploratory, Drug Safety IIT Study of EE001 in Normal Adults/Patients with Mild, Moderate, or Severe (NYHA II-IV) Cardiac Insufficiency
- ClinicalTrials.gov ID
- NCT06884111
- Acronym / sponsor ID
- AHHCEE001CSP001
- Conditions
- Cardiac Insufficiency
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Anhui HygeianCells BioMedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 19 Mar 2025 (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 study is a single-center, randomized, open, exploratory, drug-safety IIT study of EE001 in normal adults/patients with mild, moderate, or severe (grades II-IV) cardiac insufficiency. Primary aims of this study is to assess the safety and tolerability of EE001 in normal adults and patients with mild, moderate, or severe (Class II-IV) cardiac insufficiency after single and consecutive repeated doses, and to carry out a preliminary evaluation of the pharmacodynamic indexes, to understand the preliminary efficacy of the drug in applied indications. The Secondary objectives are:
- To observe the effect of EE001 on cardiac ejection index (color echocardiography) in normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency;
- To preliminarily evaluate the effect of EE001 on the cardiac functions of normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency, in accordance with the comprehensive criteria of cardiac function index.
- Six-minute walk test: to preliminarily assess the effect of EE001 on the exercise status of normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency;
- to assess the effect of EE001 on the serum levels of BNP and cardiac enzyme profiles of subjects after administration of EE001 to normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency;
- to evaluate the effect of EE001 on changes in human cytokine levels (IL-1, IL-6, IL-10, TNF-α, etc.) in normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency; and
- to evaluate the effect of EE001 on changes in the number of regulatory T cells in normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: EE001，70-105ml per day by IV |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1) Male and female subjects between 18 and 75 years of age (including upper and lower limits).
- Body Mass Index (BMI) between 19 and 28 kg/m2 (including upper and lower limits).
- Sperm and egg donation is prohibited during the study period (from signing of the Informed Consent Form to the final follow-up visit) and within 90 days of the final dose of study medication, and there is no likelihood of conception (or impregnation of a sexual partner), childbearing, or breastfeeding.
- No history of major medical problems, and there are no medical conditions during the screening period that may have contributed to the study.
- no history of major diseases, and the results of physical examination, vital signs and laboratory tests during the screening period are normal, or out of the normal reference range but not clinically significant in the judgment of the investigator.
Key exclusion criteria (15 listed)
- The presence of a medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the drug or that may interfere with adherence to the study protocol.
- Have history of hemophilia or coagulation disorders.
- Diagnosed with of endocrine, neurological, hematological, immunological (including hereditary immune deficiencies by personal or family history), psychiatric, metabolic abnormalities, lymphoproliferative disorders, severe or opportunistic infections (including herpes, tuberculosis) that in the opinion of the investigator are still clinically significant.
- Allergies, particularly to eggs or chicken.
- Participation in other clinical studies within 90 days prior to the first application of the investigational product.
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 |
|---|---|---|
| EE001，70-105ml per day by IVEE001 is a brand-new testing agent for human studies, it is the first time in human being | Drug | Single Arm |
Primary outcome
Safety assessment
Time frame: Baseline, Day 1, Day7
General toxicities and safe pharmacology properties of EE001 to human body at the applied dosage procedure will be assessed at different time point.
1 secondary outcome
Efficacy assessment
Time frame: Baseline, Day1, Day7
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 19 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EE001，70-105ml per day by IV in people with Cardiac Insufficiency, run by Anhui HygeianCells BioMedical 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 7 inclusion and 15 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 19 Mar 2025. 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. 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?
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?
Safety assessment (time frame: Baseline, Day 1, Day7). 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 19 Mar 2025.