BioavailabilityEarly Phase 1NCT06427681
An Relative Bioavailability Study of BH006 for Injection in Healthy Subjects
A Early Phase 1 study testing BH006 for injection and Fosaprepitant for injection+Palonosetron hydrochloride injection in people with Bioavailability, run by Zhuhai Beihai Biotech Co., Ltd.
Trial summary
The study is an open label, randomized, balanced, two period, two sequence, crossover, single dose, relative bioavailability study in healthy subjects.Each subject, meeting all the inclusion criteria and none of the exclusion criteria, will receive test product or reference product in a crossover manner based on… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- BH006 for injection and Fosaprepitant for injection+Palonosetron hydrochloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2024to 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to provide signed and dated informed consent prior to any study-related procedures.
- Willing and able to comply with all study procedures.
- Subjects and their spouses must agree to use adequate contraception 14 days prior to the first dose, for the duration of study participation, and for 6 months following completion of therapy.
- Healthy subjects of either gender, ≥18 years of age, or ≤ 55 years of age.
- Have a body weight (BW) of ≥ 45.0 kg(female) / ≥ 50.0 kg(male) and 18 ≤ body mass index (BMI) ≤ 28 kg/m2.
- Subjects had normal vital signs (T: 35.9~37.6℃; P: 50~100 beats/min; BP: 90~139mmHg/60~89mmHg, all including critical values) and good organ function prior to enrollment:
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- 12-ECG: QTc <450 milliseconds for males and <470 milliseconds for females;
- Platelets ≥ 100 × 109/L; neutrophil count ≥ 1.5 × 109/L; hemoglobin ≥ 110 g/L;
- Alanine aminotransferase, aspartate aminotransferase and bilirubin ≤ ULN;
- Subjects with abnormal values on physical examination and the rest of the laboratory tests were also enrolled if the investigator determined that the abnormality was not clinically significant in the context of past medical history.
Who cannot join
- Those who are known to be allergic to the investigational drug, its excipients, or similar drugs, or those who suffer from allergic diseases or belong to an allergic constitution (such as allergies to two or more drugs, food, or pollen).
- Those who have a history of clinically serious disease and have not been cured, or those who currently have a disease that may significantly affect the PK or safety evaluation of the study drug.
- Those with abnormal and clinically significant vital signs, 12-ECG, and clinical laboratory tests.
- Major surgery within 90 days prior to study entry; minor surgery within 2 weeks prior to study entry.
- Subjects who have received a vaccination within 30 days prior to the first dose.
- Subjects who have used or using any drug within 30 days prior to the first dose that may have a significant impact on the PK or safety evaluation of this study drug, including, but not limited to, CYP3A4 inhibitors/agonists, drugs that may alter activity of drug metabolizing enzyme of liver.
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- Subjects who have participated in and used any clinical trial drug within 90 days prior to the first dose, or plan to participate in other clinical trials during this study.
- Those with a history of alcohol abuse, or regular drinkers within 90 days prior to the first dose (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or those who could not abstain during the test, or had a positive alcohol breath test. (1 unit = 1 unit of alcohol = about 285 mL of beer or about 100 mL of red wine or about 25 mL of beverage containing 40% (v/v) alcohol).
- Subjects who are addicted to tobacco (more than 5 cigarettes or equivalent per day) within 30 days prior to the first dose, or who were unable to quit smoking during the trial.
- Subjects who have lost/donated more than 450 mL of blood (except physiological blood loss in females) within 90 days prior to the first dose, or who have received a blood transfusion or used a blood product, or who plan to donate blood during the trial or within 30 days of the end of the trial.
- Subjects who have taken a special diet (including pitaya, mango, grapefruit, etc.) or have had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, or excretion within 14 days prior to the first dose.
- Consumption of food or beverages containing alcoholic products or caffeine or xanthine within 48 hours before the first dose.
- Subjects have a history of drug abuse within the past five years or a positive drug abuse screen.
- Subjects have presence of Hepatitis B surface antigen (HBsAg) or a Positive Hepatitis C antibody test result, or positive human immunodeficiency virus (HIV) antibody test, or Positive test for syphilis spirochete antibodies at screening.
- Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test result at screening.
- Subjects have other clinical significant findings within the 12 months prior to screening that indicate clinically significant disease of the following (including, but not limited to, gastrointestinal, renal, hepatic, neurological, haematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular disorders); and suffering from any condition that increases the risk of haemorrhage such as haemorrhoids, acute gastritis, or gastric and duodenal ulcers, intractable constipation.
- Subjects who have a history of needle sickness, blood sickness or have a problem in collecting blood.
- Subjects who have an acute illness or concomitant medication from the screening phase until the first dose.
- Subjects who are engaged in high-altitude work, vehicle driving and other operators of machinery associated with danger.
- Subjects have other issues that may lead to non-compliance or be unsuitable for inclusion by investigators' judgement.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-label, Randomized, Single-dose, Two-period Cross-over Study to Evaluate the Relative Bioavailability Between BH006 for Injection Per the Intended Dosage Regimen and Fosaprepitant and Palonosetron in Healthy Subjects
The study is an open label, randomized, balanced, two period, two sequence, crossover, single dose, relative bioavailability study in healthy subjects.Each subject, meeting all the inclusion criteria and none of the exclusion criteria, will receive test product or reference product in a crossover manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 15 (Period II).
- Conditions
- Bioavailability
- Being tested
- BH006 for injection, Fosaprepitant for injection+Palonosetron hydrochloride injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BH006 for injectionDrug
According to the random administration plan, the test product BH006 [(fosaprepitant and palonosetron) for injection] 150mg/0.25mg or the reference product [EMEND® (fosaprepitant) for injection 150 mg + Palonosetron hydrochloride injection 0.25 mg) were injected, and crossovered after a sufficient washing period (14 days), dosing is carried out for the second cycle study.
Fosaprepitant for injection+Palonosetron hydrochloride injectionDrug
Also called EMEND®+PALONOSETRON
According to the random administration plan, the test product BH006 [(fosaprepitant and palonosetron) for injection] 150mg/0.25mg or the reference product [EMEND® (fosaprepitant) for injection 150 mg + Palonosetron hydrochloride injection 0.25 mg) were injected, and crossovered after a sufficient washing period (14 days), dosing is carried out for the second cycle study.
| Study group | Role | What they receive |
|---|---|---|
| BH006 for injection | Experimental | 150 mg fosaprepitant/0.25 mg palonosetron intravenously 30 minutes (±1 minute) Receives: Drug: BH006 for injection |
| Fosaprepitant for injection+Palonosetron hydrochloride injection | Active comparator | Fosaprepitant for injection：150 mg fosaprepitant intravenously 30 minutes (±1 minute) ; Palonosetron hydrochloride injection： 0.25 mg palonosetron in 5 mL (0.05 mg/mL) infusion time is 30 seconds (﹢5seconds) . Receives: Drug: Fosaprepitant for injection+Palonosetron hydrochloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Analysis
The PK endpoints will be studied and assessed by PK parameters for aprepitant and palonosetron:Area Under the Curve From Time 0 Hours to Last Quantifiable Concentration(AUC0-t).
Measured: Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
Pharmacokinetic Analysis
The PK endpoints will be studied and assessed by PK parameters for aprepitant and palonosetron:Area Under the Curve From Time 0 Hours to Infinity(AUC0-∞).
Measured: Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
Pharmacokinetic Analysis
The PK endpoints will be studied and assessed by PK parameters for aprepitant :Maximum Concentration (Cmax).
Measured: Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
Secondary outcomes (2)
Pharmacokinetic Analysis
For aprepitant, aprepitant and palonosetron : Apparent Terminal Elimination Half-Life (t1/2).
Measured: Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
Pharmacokinetic Analysis
For aprepitant, aprepitant and palonosetron : Time to Cmax (Tmax).
Measured: Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study startMay 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuhai Beihai Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Zhang, PI, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427681
- Sponsor's protocol ID
- BH006-BE-102
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, Two-period Cross-over Study to Evaluate the Relative Bioavailability Between BH006 for Injection Per the Intended Dosage Regimen and Fosaprepitant and Palonosetron in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06427681
- Acronym / sponsor ID
- BH006-BE-102
- Conditions
- Bioavailability
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhuhai Beihai Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- May 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 May 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 an open label, randomized, balanced, two period, two sequence, crossover, single dose, relative bioavailability study in healthy subjects.Each subject, meeting all the inclusion criteria and none of the exclusion criteria, will receive test product or reference product in a crossover manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 15 (Period II).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BH006 for injection | Experimental | Drug: BH006 for injection150 mg fosaprepitant/0.25 mg palonosetron intravenously 30 minutes (±1 minute) |
| Fosaprepitant for injection+Palonosetron hydrochloride injection | Active comparator | Drug: Fosaprepitant for injection+Palonosetron hydrochloride injectionFosaprepitant for injection：150 mg fosaprepitant intravenously 30 minutes (±1 minute) ; Palonosetron hydrochloride injection： 0.25 mg palonosetron in 5 mL (0.05 mg/mL) infusion time is 30 seconds (﹢5seconds) . |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Willing and able to provide signed and dated informed consent prior to any study-related procedures.
- Willing and able to comply with all study procedures.
- Subjects and their spouses must agree to use adequate contraception 14 days prior to the first dose, for the duration of study participation, and for 6 months following completion of therapy.
- Healthy subjects of either gender, ≥18 years of age, or ≤ 55 years of age.
- Have a body weight (BW) of ≥ 45.0 kg(female) / ≥ 50.0 kg(male) and 18 ≤ body mass index (BMI) ≤ 28 kg/m2.
Key exclusion criteria (20 listed)
- Those who are known to be allergic to the investigational drug, its excipients, or similar drugs, or those who suffer from allergic diseases or belong to an allergic constitution (such as allergies to two or more drugs, food, or pollen).
- Those who have a history of clinically serious disease and have not been cured, or those who currently have a disease that may significantly affect the PK or safety evaluation of the study drug.
- Those with abnormal and clinically significant vital signs, 12-ECG, and clinical laboratory tests.
- Major surgery within 90 days prior to study entry; minor surgery within 2 weeks prior to study entry.
- Subjects who have received a vaccination within 30 days prior to the first dose.
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 |
|---|---|---|
| BH006 for injectionAccording to the random administration plan, the test product BH006 [(fosaprepitant and palonosetron) for injection] 150mg/0.25mg or the reference product [EMEND® (fosaprepitant) for injection 150 mg + Palonosetron hydrochloride injection 0.25 mg) were injected, and crossovered after a sufficient washing period (14 days), dosing is carried out for the second cycle study. | Drug | BH006 for injection |
| Fosaprepitant for injection+Palonosetron hydrochloride injectionAlso: EMEND®+PALONOSETRONAccording to the random administration plan, the test product BH006 [(fosaprepitant and palonosetron) for injection] 150mg/0.25mg or the reference product [EMEND® (fosaprepitant) for injection 150 mg + Palonosetron hydrochloride injection 0.25 mg) were injected, and crossovered after a sufficient washing period (14 days), dosing is carried out for the second cycle study. | Drug | Fosaprepitant for injection+Palonosetron hydrochloride injection |
Primary outcome
Pharmacokinetic Analysis
Time frame: Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
The PK endpoints will be studied and assessed by PK parameters for aprepitant and palonosetron:Area Under the Curve From Time 0 Hours to Last Quantifiable Concentration(AUC0-t).
Pharmacokinetic Analysis
Time frame: Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
The PK endpoints will be studied and assessed by PK parameters for aprepitant and palonosetron:Area Under the Curve From Time 0 Hours to Infinity(AUC0-∞).
Pharmacokinetic Analysis
Time frame: Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
The PK endpoints will be studied and assessed by PK parameters for aprepitant :Maximum Concentration (Cmax).
2 secondary outcomes
Pharmacokinetic Analysis
Time frame: Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
Pharmacokinetic Analysis
Time frame: Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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.
Hong Zhang, PI principal investigator
The First Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BH006 for injection and Fosaprepitant for injection+Palonosetron hydrochloride injection in people with Bioavailability, run by Zhuhai Beihai Biotech Co., Ltd.
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 10 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 24 May 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. 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 Xiaohua Wei, PMD (+86 13500248359, xhwei@bayhibiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Analysis (time frame: Period I&Period II：pre-dose to 168.000 hours after starting the infusion.). The study lists 3 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 24 May 2024.