NCT05989997

Phase I Clinical Trial of 68Ga-NOTA-SNA002

Phase I Clinical Trial of Evaluating 68Ga-NOTA-SNA002 for the Safety Tolerance, Radiation Absorbed Dose and Dosimetry in Patients With Solid Tumor

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: SmartNuclide Biopharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The clinical trial was a single-center, dose-increasing, open trial.In this clinical trial, 68Ga-NOTA-SNA002 was injected intravenously to observe its safety tolerance, radiation absorption dose, distribution characteristics, etc. in patients with solid tumors.

Detailed description

The study consisted of four phases: screening period , baseline period , trial period and safety follow-up period . Screening period 2 weeks before the start of the trial, all eligible subjects were selected to participate in the clinical trial. The informed consent signed by the subjects is required before performing all the examinations in this clinical trial. Baseline period The admission criteria were checked again, and the subjects were enrolled on the same day after the check. Trial period Including drug administration, blood collection, image collection and pathological tissue collection. Safe follow-up period All adverse events and drug combinations are processed and recorded during this period.

Conditions

• Solid Tumor
• Positron-Emission Tomography(PET)

Interventions

Type	Name	Description
DRUG	68Ga-NOTA-SNA002	68Ga-NOTA-SNA002 should be injected intravenously slowly for no less than 1min.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-11-08
• Completion: 2024-11-08
• First posted: 2023-08-14
• Last updated: 2025-09-16

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study