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COMPLETED Phase 1

Safety, Tolerability, and Pharmacokinetics of Andecaliximab in Adults With Chronic Obstructive Pulmonary Disease (COPD)

NCT02077465 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of the study is to assess the safety and tolerability of multiple infusions of andecaliximab (formerly GS-5745) in participants with chronic obstructive pulmonary disease (COPD) as assessed by adverse events (AEs) and laboratory abnormalities.

Interventions

  • DRUG Andecaliximab
  • DRUG Placebo to match Andecaliximab

Study Locations (5)

Florida

  • Advanced Pharma CR, LLC — Miami
  • Elite Research Institute — Miami
  • Compass Research, LLC — Orlando

New York

  • University at Buffalo CTRC — Buffalo

Tennessee

  • Volunteer Research Group — Knoxville

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2014-03-11
Est. Completion 2014-10-27
Phase Phase 1

Sponsor

Gilead Sciences

190 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02077465

The ClinicalTrials.gov registry entry for NCT02077465 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 2 interventions — of which Andecaliximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02077465 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Florida, New York, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02077465 about?

NCT02077465 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of Andecaliximab in Adults With Chronic Obstructive Pulmonary Disease (COPD)". The primary objective of the study is to assess the safety and tolerability of multiple infusions of andecaliximab (formerly GS-5745) in participants with chronic obstructive pulmonary disease (COPD) as assessed by adverse events (AEs) and laboratory abnormalities.

What is the current status of trial NCT02077465?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2014-03-11. Estimated completion is 2014-10-27.

What conditions does trial NCT02077465 study?

This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02077465?

The interventions under investigation include: Andecaliximab (DRUG), Placebo to match Andecaliximab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02077465?

This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02077465 being conducted?

This trial has 5 study locations across Florida, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial