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NCT05808673WITHDRAWNanonymous

A Randomized, Double-blind, Parallel Controlled, Phase I Three-arm Study, Comparing the PK, PD, Safety, and Immunogenicity of Pre- and Post-change CMAB807X, Post-change CMAB807X and Xgeva® in Healthy Chinese Male Subjects

Sponsor

Source record

Taizhou Mabtech Pharmaceutical Co.,Ltd

Phase

Source record

PHASE1

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Post-change CMAB807X, Pre-change CMAB807X, Xgeva®

Indication / condition

AI-normalized

Healthy Volunteers

Intervention

Source record

Post-change CMAB807X, Pre-change CMAB807X, Xgeva®

Source & freshness

Source record

NCT ID

NCT05808673

Original source

ClinicalTrials.gov

Source last updated

Apr 09, 2024

Ingested at

Jun 18, 2026

Internal sync

Jun 18, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT05808673

Title

A Randomized, Double-blind, Parallel Controlled, Phase I Three-arm Study, Comparing the PK, PD, Safety, and Immunogenicity of Pre- and Post-change CMAB807X, Post-change CMAB807X and Xgeva® in Healthy Chinese Male Subjects

Sponsor

Taizhou Mabtech Pharmaceutical Co.,Ltd

Status

WITHDRAWN

Phase

PHASE1

Condition raw

Healthy Volunteers

Condition normalized

Healthy Volunteers

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Post-change CMAB807X, Pre-change CMAB807X, Xgeva®

Target normalized

Post-change CMAB807X, Pre-change CMAB807X, Xgeva®

Interventions

Post-change CMAB807X, Pre-change CMAB807X, Xgeva®

Public preview

Source record

This is a randomized, double-blinded, controlled Phase I three-arms study of CMAB807X administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807X Pre- and Post-change in Manufacturing Site, and Post-change CMAB807X versus Xgeva® #Denosumab# in healthy male subjects after a single dose

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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