Renal AnemiaPhase 4NCT05864261
Pharmacokinetics Comparison Study of JT1801 and NESP® After Single Dose Administration in Chinese Health Male Volunteers
A Phase 4 study testing JT1801 60ug and NESP 60ug in people with Renal Anemia, run by Yi Fang at 1 site in China.
Trial summary
The purpose of this study is to compare the similarity of major pharmacokinetic parameters after a single intravenous administration of JT1801 and NESP® in chinese healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Renal Anemia
- What is being tested?
- JT1801 60ug and NESP 60ug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2023to 28 Aug 2023
- Phase
- Phase 4
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese healthy adult male subjects.
- Age of 18 to 55 years, inclusive.
- Subject with BMI between 19 kg/m2 and 26 kg/m2 (inclusive); and a total body weight ≥50 kg.
- Subject who agree to practive effective barrier contraception and avoid sperm donation during the entire study period and through at least 3 months after the last dose of study drug.
- Subject who provided written informed consent voluntarily after being fully informed of the study.
- Subject who is able to communicate well with the investigator and participate in the whole study process according to protocol.
Who cannot join
- During the screening period, vital signs measurement, physical examination, laboratory examination (blood routine, reticulocyte, urine routine, blood biochemistry, coagulation function, anemia, transferrin saturation, IgE detection), B-ultrasound examination, chest X-ray and 12-lead electrocardiogram examination showed abnormal results and were judged by the investigator to be clinically significant.
- History of chronic disease or serious disease in cardiovascular, liver, kidney, biliary tract, respiratory, blood, lymphatic, endocrinological, immunologic, psychiatric, neuromuscular, gastrointestinal system within three years.
- Have a history of specific allergies (e.g. hives) or are allergic (e.g. are known to be allergic to two or more drugs), or have a history of allergy to this ingredient or to EPO drugs.
- Subjects with past or present history of hypertension, stroke, thromboembolism, convulsion, epilepsy or pure red cell aplasia.
- Subject with severe psychological or mental illness.
- Subject with a previous history of tumors.
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- The investigator considers that there are other medical conditions that may affect the study results and the safety of the subjects.
- Subject who had surgery within 6 months prior to screening period that the investigators determined would affect drug absorption, distribution, metabolism, or excretion, or who planned to have surgery during the study period.
- Subject who have received other biologics within 6 months.
- Those with a history of drug abuse (including the use of various narcotic drugs and psychotropic substances for non-medical destinations) or positive drug abuse screening (including morphine, methamphetamine, ketamine, dimethylenedioxyamphetamine, tetrahydrocannabinolic acid, etc.) before the test.
- Positive for any of the virological tests, including human immunodeficiency virus, hepatitis C antibody, hepatitis B surface antigen, and treponema pallidum antibody.
- Subjects who have donated blood or lost blood from other reasons within 6 months prior to screening with a total of 400mL or received blood transfusions or used blood products.
- Has a history of alcohol abuse within 1 year prior to screening, whereby drink more than 2 units of alcohol per week on average (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or alcohol breath test results greater than 0.0mg/100 ml.
- In the past year, the average daily consumption of excessive tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup ≈250mL).
- Those who smoked > 5 cigarettes per day within 3 months before screening or could not refrain from smoking during the test.
- Those who have used any drugs (prescription drugs, over-the-counter drugs, vitamins, Chinese herbal medicines, health supplements) within 30 days before enrollment.
- Those who have used systemic glucocorticoids within 3 months before enrollment.
- Those who have participated in other clinical trials within 3 months before enrollment.
- Those who cannot tolerate venipuncture or have a history of needle sickness and blood sickness.
- Those who have special requirements for diet and cannot accept a unified diet.
- Subjects who received the vaccine within 3 months prior to the first dosing, or plan to be vaccinated during the study or within 1 week after the last dosing.
- Those with a low probability of enrollment or poor adherence (such as frailty, physical exhaustion, dehydration or malnutrition, etc.) according to the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 101149
About this study
Official title: A Randomized, Blinding, Single-dose, Positive-drug Parallel Control Study to Compare the Pharmacokinetics Following Administration of JT1801 and Darbepoetin Alfa Injection (NESP®) in Chinese Healthy Adult Volunteers
The purpose of this study is to compare the similarity of major pharmacokinetic parameters after a single intravenous administration of JT1801 and NESP® in chinese healthy male volunteers. And to evaluate the safety, immunogenicity and pharmacodynamic characteristics of JT1801 and NESP® in chinese healthy male volunteers
- Conditions
- Renal Anemia
- Being tested
- JT1801 60ug, NESP 60ug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JT1801 60ugDrug
JT1801, 60ug, IV injection
NESP 60ugDrug
NESP, 60ug, IV injection
| Study group | Role | What they receive |
|---|---|---|
| JT1801 | Experimental | Not described Receives: Drug: JT1801 60ug |
| NESP | Active comparator | Not described Receives: Drug: NESP 60ug |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
PK parameters comparison between JT1801 and darbepoetin alfa: AUC0-t
Measured: Pre-dose and after dose 20 days
AUC0-∞
PK parameters comparison between JT1801 and darbepoetin alfa: AUC0-∞
Measured: Pre-dose and after dose 20 days
Secondary outcomes (5)
TEmax
PD parameters comparison between JT1801 and darbepoetin alfa: TEmax of reticulocyte count, hematocrit, hemoglobin concentration, RBC
Measured: Pre-dose and after dose 15 days
Emax
PD parameters comparison between JT1801 and darbepoetin alfa: Emax of reticulocyte count, hematocrit, hemoglobin concentration, RBC
Measured: Pre-dose and after dose 15 days
AUEC0-t
PD parameters comparison between JT1801 and darbepoetin alfa: AUEC0-t of reticulocyte count, hematocrit, hemoglobin concentration, RBC
Measured: Pre-dose and after dose 15 days
ΔAUEC0-t
PD parameters comparison between JT1801 and darbepoetin alfa: ΔAUEC0-t of reticulocyte count, hematocrit, hemoglobin concentration, RBC
Measured: Pre-dose and after dose 15 days
ΔEmax
PD parameters comparison between JT1801 and darbepoetin alfa: ΔEmax of reticulocyte count, hematocrit, hemoglobin concentration, RBC
Measured: Pre-dose and after dose 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start15 May 2023
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal AnemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yi Fang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Fang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864261
- Sponsor's protocol ID
- 2022-I-JT1801-01
- Status last verified
- Nov 2023
- First submitted
- 9 May 2023
- Last updated
- 22 Nov 2023
- Results posted
- 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 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinding, Single-dose, Positive-drug Parallel Control Study to Compare the Pharmacokinetics Following Administration of JT1801 and Darbepoetin Alfa Injection (NESP®) in Chinese Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05864261
- Acronym / sponsor ID
- 2022-I-JT1801-01
- Conditions
- Renal Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Yi FangUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 18 May 2023 (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 purpose of this study is to compare the similarity of major pharmacokinetic parameters after a single intravenous administration of JT1801 and NESP® in chinese healthy male volunteers. And to evaluate the safety, immunogenicity and pharmacodynamic characteristics of JT1801 and NESP® in chinese healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JT1801 | Experimental | Drug: JT1801 60ug |
| NESP | Active comparator | Drug: NESP 60ug |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Chinese healthy adult male subjects.
- Age of 18 to 55 years, inclusive.
- Subject with BMI between 19 kg/m2 and 26 kg/m2 (inclusive); and a total body weight ≥50 kg.
- Subject who agree to practive effective barrier contraception and avoid sperm donation during the entire study period and through at least 3 months after the last dose of study drug.
- Subject who provided written informed consent voluntarily after being fully informed of the study.
Key exclusion criteria (22 listed)
- During the screening period, vital signs measurement, physical examination, laboratory examination (blood routine, reticulocyte, urine routine, blood biochemistry, coagulation function, anemia, transferrin saturation, IgE detection), B-ultrasound examination, chest X-ray and 12-lead electrocardiogram examination showed abnormal results and were judged by the investigator to be clinically significant.
- History of chronic disease or serious disease in cardiovascular, liver, kidney, biliary tract, respiratory, blood, lymphatic, endocrinological, immunologic, psychiatric, neuromuscular, gastrointestinal system within three years.
- Have a history of specific allergies (e.g. hives) or are allergic (e.g. are known to be allergic to two or more drugs), or have a history of allergy to this ingredient or to EPO drugs.
- Subjects with past or present history of hypertension, stroke, thromboembolism, convulsion, epilepsy or pure red cell aplasia.
- Subject with severe psychological or mental illness.
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 |
|---|---|---|
| JT1801 60ugJT1801, 60ug, IV injection | Drug | JT1801 |
| NESP 60ugNESP, 60ug, IV injection | Drug | NESP |
Primary outcome
AUC0-t
Time frame: Pre-dose and after dose 20 days
PK parameters comparison between JT1801 and darbepoetin alfa: AUC0-t
AUC0-∞
Time frame: Pre-dose and after dose 20 days
PK parameters comparison between JT1801 and darbepoetin alfa: AUC0-∞
5 secondary outcomes
TEmax
Time frame: Pre-dose and after dose 15 days
Emax
Time frame: Pre-dose and after dose 15 days
AUEC0-t
Time frame: Pre-dose and after dose 15 days
ΔAUEC0-t
Time frame: Pre-dose and after dose 15 days
ΔEmax
Time frame: Pre-dose and after dose 15 days
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 22 Nov 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing JT1801 60ug and NESP 60ug in people with Renal Anemia, run by Yi Fang 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 6 inclusion and 22 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 22 Nov 2023. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
AUC0-t (time frame: Pre-dose and after dose 20 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.