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NCT06361355COMPLETEDanonymous

A Randomized, Double-blind, Parallel Controlled, Phase I Study, Comparing the PK, PD, Safety, and Immunogenicity of Post-change CMAB807and Prolia in Healthy Chinese Subjects

Sponsor

Source record

Taizhou Mabtech Pharmaceutical Co.,Ltd

Phase

Source record

PHASE1

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Post-change CMAB807, Prolia

Indication / condition

AI-normalized

Healthy Volunteers

Intervention

Source record

Post-change CMAB807, Prolia

Source & freshness

Source record

NCT ID

NCT06361355

Original source

ClinicalTrials.gov

Source last updated

Nov 07, 2024

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT06361355

Title

A Randomized, Double-blind, Parallel Controlled, Phase I Study, Comparing the PK, PD, Safety, and Immunogenicity of Post-change CMAB807and Prolia in Healthy Chinese Subjects

Sponsor

Taizhou Mabtech Pharmaceutical Co.,Ltd

Status

COMPLETED

Phase

PHASE1

Condition raw

Healthy Volunteers

Condition normalized

Healthy Volunteers

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Post-change CMAB807, Prolia

Target normalized

Post-change CMAB807, Prolia

Interventions

Post-change CMAB807, Prolia

Public preview

Source record

This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807 Post-change in Manufacturing Site, versus Prolia #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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TrialSignal

Clinical trial intelligence report

A Randomized, Double-blind, Parallel Controlled, Phase I Study, Comparing the PK, PD, Safety, and Immunogenicity of Post-change CMAB807and Prolia in Healthy Chinese Subjects

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT06361355

Status

COMPLETED

Phase

PHASE1

Sponsor

Taizhou Mabtech Pharmaceutical Co.,Ltd

Executive brief

Investment-Ready Snapshot

This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807 Post-change in Manufacturing Site, versus Prolia #Denosumab# in healthy male subjects after a single dose

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedNov 07, 2024
Internal syncJun 11, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT06361355

Indication

Healthy Volunteers

Modality

monoclonal antibody

Target

Post-change CMAB807, Prolia

Intervention

Post-change CMAB807, Prolia

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.