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

Zhuhai Beihai Biotech Co., Ltd0 sites40 target enrollmentMay 2024

ConditionsBioavailability

InterventionsBH006 for injection Fosaprepitant for injection+Palonosetron hydrochloride injection

DrugsBH006 for injection Fosaprepitant for injection+Palonosetron hydrochloride injection

Overview

Phase: Early Phase 1
Intervention: BH006 for injection
Conditions: Bioavailability
Sponsor: Zhuhai Beihai Biotech Co., Ltd
Enrollment: 40
Primary Endpoint: Pharmacokinetic Analysis
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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 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).

Registry

clinicaltrials.gov

Start Date

May 2024

End Date

December 2024

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Zhuhai Beihai Biotech Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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/m
•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:
•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.

Exclusion Criteria

•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.
•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.

Arms & Interventions

BH006 for injection

150 mg fosaprepitant/0.25 mg palonosetron intravenously 30 minutes (±1 minute)

Intervention: BH006 for injection

Fosaprepitant for injection+Palonosetron hydrochloride injection

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) .

Intervention: Fosaprepitant for injection+Palonosetron hydrochloride injection