Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of a Single Dose of Gallium [68Ga]-NYM032 Injection Prepared by Kit for the Preparation of the 68Ga-NYM032 Injection in Patients With Prostate Cancer

68Ga-NYM032 is a PSMA-targeting small-molecular radiotracer for PET/CT imaging of prostate cancer, which is needed for clinical trial to be conducted

Start Date04 Jun 2024

Sponsor / Collaborator

Norroy Bioscience Co., LTD

CTR20241621

/ CompletedPhase 1/2

镓[68Ga]-NYM032注射液在健康受试者、前列腺癌患者体内的药代动力学、生物分布、辐射剂量和安全性研究

[Translation] Study on the pharmacokinetics, biodistribution, radiation dose and safety of gallium [68Ga]-NYM032 injection in healthy subjects and prostate cancer patients

Ⅰa期主要目的：评估68Ga-NYM032注射液在健康受试者体内的安全性和辐射安全性。次要目的： 1、评价不同剂量68Ga-NYM032注射液在健康受试者体内的药代动力学； 2、评价不同剂量68Ga-NYM032注射液在健康受试者体内的生物分布； 3、评价不同剂量68Ga-NYM032注射液在健康受试者体内的图像质量。 Ⅰb/Ⅱa期主要目的：评估68Ga-NYM032注射液在前列腺癌患者体内的安全性和辐射安全性。次要目的： 1、评价68Ga-NYM032注射液在前列腺癌患者体内的药代动力学； 2、评价68Ga-NYM032注射液在前列腺癌患者体内的生物分布； 3、评价68Ga-NYM032注射液在前列腺癌患者体内的图像质量； 4、评价68Ga-NYM032注射液在前列腺癌患者体内的诊断效能； 5、评价不同阅片间和同一阅片者内68Ga-NYM032注射液在前列腺癌患者体内的诊断一致性。

[Translation]

Phase Ia Main purpose: To evaluate the safety and radiation safety of 68Ga-NYM032 injection in healthy subjects. Secondary purposes: 1. To evaluate the pharmacokinetics of different doses of 68Ga-NYM032 injection in healthy subjects; 2. To evaluate the biodistribution of different doses of 68Ga-NYM032 injection in healthy subjects; 3. To evaluate the image quality of different doses of 68Ga-NYM032 injection in healthy subjects. Phase Ib/IIa Main purpose: To evaluate the safety and radiation safety of 68Ga-NYM032 injection in patients with prostate cancer. Secondary objectives: 1. Evaluate the pharmacokinetics of 68Ga-NYM032 injection in patients with prostate cancer; 2. Evaluate the biodistribution of 68Ga-NYM032 injection in patients with prostate cancer; 3. Evaluate the image quality of 68Ga-NYM032 injection in patients with prostate cancer; 4. Evaluate the diagnostic efficacy of 68Ga-NYM032 injection in patients with prostate cancer; 5. Evaluate the diagnostic consistency of 68Ga-NYM032 injection in patients with prostate cancer between different readers and within the same reader.

Start Date04 Jun 2024

Sponsor / Collaborator

Norroy Bioscience Co., LTD

NCT05623878

/ RecruitingEarly Phase 1IIT

68Ga-labeled NY108 PET Imaging in Patients

This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY108 (68Ga-NY108) PET Imaging in patients.

Start Date04 Jan 2022

Sponsor / Collaborator

Affiliated Hospital of Jiangnan University

100 Clinical Results associated with 68Ga-NYM032

100 Translational Medicine associated with 68Ga-NYM032

100 Patents (Medical) associated with 68Ga-NYM032

100 Deals associated with 68Ga-NYM032

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of prostate	Phase 3	China	Norroy Bioscience Co., LTD	28 Feb 2026
Localized Prostate Carcinoma	Phase 3	China	Norroy Bioscience Co., LTD	28 Feb 2026
Metastatic Prostate Carcinoma	Phase 2	China	Norroy Bioscience Co., LTD	04 Jun 2024
Prostatic Cancer	Phase 1	China	Affiliated Hospital of Jiangnan University	04 Jan 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06389695 (Phase Ia study, ASCO2025)	Phase 1	Prostatic Cancer	9	74 MBq of 68Ga-NYM032	bsnopogxev(xjezpmuqjr) = cdmqeuzuwg lcozmkuzfn (emkedlxbid ) View more	Positive	30 May 2025
				148 MBq of 68Ga-NYM032	bsnopogxev(xjezpmuqjr) = xrhqtmzvpl lcozmkuzfn (emkedlxbid ) View more

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