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Phase I Study to Evaluate PK Similarity of Recombinant Fully Human Anti-programmed Death Receptor 1 Monoclonal Antibody Injection Before and After IBI308 Manufacturing Process Change in Healthy Chinese Male Subjects

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Trial Profile

Phase I Study to Evaluate PK Similarity of Recombinant Fully Human Anti-programmed Death Receptor 1 Monoclonal Antibody Injection Before and After IBI308 Manufacturing Process Change in Healthy Chinese Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 Aug 2023

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At a glance

  • Drugs Sintilimab (Primary)
  • Indications Acral lentiginous melanoma; Cancer; Cervical cancer; Colorectal cancer; Extranodal NK-T-cell lymphoma; Gastric cancer; Hodgkin's disease; Liver cancer; Lung cancer; Lymphoma; Nasopharyngeal cancer; Non-small cell lung cancer; Oesophageal cancer; Small cell lung cancer; Solid tumours
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Innovent Biologics

Most Recent Events

  • 16 Aug 2023 Status changed from recruiting to completed.
  • 05 Dec 2022 Planned number of patients changed from 98 to 110.
  • 29 Nov 2022 Planned number of patients changed from 154 to 98.

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