NCT01202695

Brief Summary

Primary:

  • To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo Secondary:
  • To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9
  • To evaluate the immunogenicity of AVP-21D9

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

September 13, 2010

Last Update Submit

March 14, 2024

Conditions

Anthrax

Outcome Measures

Primary Outcomes (1)

  • Safety assessments

    Safety will be assessed by collecting data (physical exams, adverse event reporting, lab testing/analysis) and concomitant medications at each visit from pre-infusion period through post-infusion day 90 or the early withdrawl visit, if applicable.

    90 days following infusion

Secondary Outcomes (2)

  • Pharmacokinetics (PK) analysis

    90 days following infusion

  • Immunogenicity analysis

    From day 1 up to day 90 following infusion

Study Arms (2)

AVP-21D9

EXPERIMENTAL
Drug: AVP-21D9

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AVP-21D9DRUG

intravenously, single dose

AVP-21D9
PlaceboDRUG

Placebo comparator

Also known as: Placebo comparator
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers, between 18 and 45 years of age
  • Normal laboratory (blood test) results

You may not qualify if:

  • Prior immunization with anthrax vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON Development Solutions

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

  • Malkevich NV, Hopkins RJ, Bernton E, Meister GT, Vela EM, Atiee G, Johnson V, Nabors GS, Aimes RT, Ionin B, Skiadopoulos MH. Efficacy and safety of AVP-21D9, an anthrax monoclonal antibody, in animal models and humans. Antimicrob Agents Chemother. 2014 Jul;58(7):3618-25. doi: 10.1128/AAC.02295-13. Epub 2014 Apr 14.

    PMID: 24733473DERIVED

MeSH Terms

Conditions

Anthrax

Interventions

AVP-21D9

Condition Hierarchy (Ancestors)

Bacillaceae InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Robert Hopkins, MD

    Emergent BioSolutions

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 16, 2010

Study Start

August 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations

US(1)