deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT01357213

Phase 1 PK Study of XOMA 3AB

A Phase I, Blinded, Placebo-controlled, Dose-escalation Study of the Safety and Pharmacokinetics of XOMA 3AB Administered Intravenously in Healthy Adults

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions Botulism
Interventions Placebo XOMA 3AB
Updated 7 times since 2017 Last updated: Dec 4, 2014 Started: May 31, 2011 Primary completion: May 31, 2012 Completion: May 31, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Botulism, this trial is completed. The trial is conducted by National Institute of Allergy and Infectious Diseases (NIAID) and has accumulated 7 data snapshots since 2011. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers. Volunteers will be hospitalized in the Johns Hopkins Phase 1 unit during the infusion and until after the 24-hour blood draw. Three escalating dose cohorts of a combination of three anti-botulinum monoclonal antibodies will be evaluated. Each cohort will consist of eight volunteers in which they will receive a single intravenous infusion of active drug or placebo. Placebo will be normal saline. Volunteers will be followed for safety for up to 120 days after infusion depending on dose cohort.

This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers. Volunteers will be hospitalized in the Johns Hopkins Phase 1 unit during the infusion and until after the 24-hour blood draw. Three escalating dose cohorts of a combination of three anti-botulinum monoclonal antibodies will be evaluated. Each cohort will consist of eight volunteers in which they will receive a single intravenous infusion of active drug or placebo. Placebo will be normal saline. Volunteers will be followed for safety for up to 120 days after infusion depending on dose cohort.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Present [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1

    First recorded

May 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Allergy and Infectious Diseases (NIAID)
Data source: National Institute of Allergy and Infectious Diseases (NIAID)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations