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BCD-261 Phase 1 Study, Healthy Chinese Volunteers

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Summary

NIH ClinicalTrials.gov registered a Phase 1 study for investigational drug BCD-261, a single subcutaneous injection, to evaluate safety, pharmacodynamics, pharmacokinetics, and immunogenicity in healthy adult Chinese volunteers. The study (NCT07535775) represents early-stage clinical research.

Published by NIH on changeflow.com . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

NIH added a new clinical trial registration for BCD-261, an investigational drug, on ClinicalTrials.gov. The Phase 1 study will enroll healthy adult Chinese participants to evaluate safety, pharmacokinetics, pharmacodynamics, and immunogenicity following a single subcutaneous injection.

Sponsors conducting clinical trials should ensure accurate registration and results reporting on ClinicalTrials.gov as required under federal law. Clinical investigators should monitor this trial for potential impact on related drug development programs in similar therapeutic areas.

Archived snapshot

Apr 17, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Evaluate Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 After Single Subcutaneous Injection in Healthy Chinese Volunteers

Phase 1 NCT07535775 Kind: PHASE1 Apr 17, 2026

Abstract

The goal of this study is to evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 after Single Subcutaneous Injection in Healthy Chinese Volunteers

Conditions: Healthy Adult Participants

Interventions: BCD-261

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Last updated

Classification

Agency
NIH
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07535775

Who this affects

Applies to
Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Drug safety evaluation Pharmacokinetics study
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Healthcare

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