[Translation] A single-center, randomized, open-label, single-dose, three-dose, three-cycle, three-crossover bioequivalence study of intravenous BH006 in healthy Chinese subjects

1）主要研究目的考察由珠海贝海生物技术有限公司研制开发的注射用BH006复方制剂（受试制剂T）和注射用福沙匹坦双葡甲胺（参比制剂R1）、盐酸帕洛诺司琼注射液（参比制剂R2）经单剂量静脉注射在中国健康成年人体的药代动力学特征，评价受试制剂和参比制剂R1、参比制剂R2的生物等效性，为临床用药提供参考依据。 2）次要研究目的评价中国健康成年受试者单次输注150mg/0.25mg受试制剂注射用BH006的安全性。

[Translation]

1) Main study objectives To investigate the pharmacokinetic characteristics of the BH006 compound preparation for injection (test preparation T) and fosaprepitant dimeglumine for injection (reference preparation R1) and palonosetron hydrochloride injection (reference preparation R2) developed by Zhuhai Beihai Biotechnology Co., Ltd. after single-dose intravenous injection in healthy Chinese adults, evaluate the bioequivalence of the test preparation and reference preparations R1 and R2, and provide a reference for clinical use. 2) Secondary study objectives To evaluate the safety of a single infusion of 150mg/0.25mg of the test preparation BH006 for injection in healthy Chinese adult subjects.

Start Date-

Sponsor / Collaborator

Zhuhai Beihai Biotechnology Co., Ltd.

CTR20241584 / Not yet recruitingNot Applicable

注射用BH006在健康人体中的单中心、开放、随机、平行、两周期、两序列、双交叉、单剂量的相对生物利用度研究

[Translation] A single-center, open, randomized, parallel, two-cycle, two-sequence, double-crossover, single-dose relative bioavailability study of BH006 for injection in healthy humans

1）主要研究目的：评价受试制剂与参比制剂在健康人体内的药代动力学及相对生物利用度。 2）次要研究目的：评估不良事件（AE），并评估研究药物的安全性和耐受性。

[Translation]

1) Primary study objectives: To evaluate the pharmacokinetics and relative bioavailability of the test formulation and the reference formulation in healthy subjects. 2) Secondary study objectives: To assess adverse events (AEs) and evaluate the safety and tolerability of the study drug.

Start Date-

Sponsor / Collaborator

Zhuhai Beihai Biotechnology Co., Ltd.

NCT06427681 / Not yet recruitingEarly Phase 1

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).

Start Date01 May 2024

Sponsor / Collaborator

Zhuhai Beihai Biotechnology Co., Ltd.

100 Clinical Results associated with Fosaprepitant dimeglumine/palonosetron hydrochloride

100 Translational Medicine associated with Fosaprepitant dimeglumine/palonosetron hydrochloride

100 Patents (Medical) associated with Fosaprepitant dimeglumine/palonosetron hydrochloride

100 Deals associated with Fosaprepitant dimeglumine/palonosetron hydrochloride

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Chemotherapy-induced nausea and vomiting	Phase 3	CN	Zhuhai Beihai Biotechnology Co., Ltd.	04 Nov 2022

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