Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers

NCT01929226 | Completed Phase 1 Results

• 1 other identifier: AH104
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability and pharmacokinetics (PK) of a single intravenous (IV) dose of ETI-204 in adult volunteers.

Conditions

Inhalational Anthrax

Keywords

anthrax, monoclonal antibody, ETI-204, safety, PK

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced Adverse Events

  Safety was assessed for all subjects in the safety population by collecting and monitoring vital signs, clinical laboratory tests, ECGs, physical examinations, skin assessments, infusion site assessments, and adverse events.

  Up to 71 days or 101 days (30 days after the final study visit) for subjects with ongoing adverse events at the final study visit, for each group.

Secondary Outcomes (9)

• Maximum Observed Plasma Concentration of ETI-204 (Cmax)

  On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71.

• Time to Maximum Observed Plasma Concentration of ETI-204 (Tmax)

  On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71.

• Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last)

  On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71.

• Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf)

  On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71.

• Terminal Half-life (t1/2)

  On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71.

Study Arms (2)

ETI-204

EXPERIMENTAL

A single intravenous dose of 16 mg/kg ETI-204 infused over 90 minutes on Day 1

Biological: ETI-204

Placebo for ETI-204

PLACEBO COMPARATOR

A single intravenous dose of ETI-204-placebo infused over 90 minutes on Day 1

Other: Placebo

Interventions

ETI-204 BIOLOGICAL

Monoclonal Antibody

ETI-204

Placebo OTHER

Placebo for ETI-204

Placebo for ETI-204

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females or males ≥ 18 years of age
• All females, regardless of childbearing potential, must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test at Screening and Day -1
• Females of childbearing potential (i.e., not postmenopausal or surgically sterile) must agree to practice abstinence or to use a medically accepted method of contraception from the time of Screening through 30 days after final study visit. Acceptable methods of contraception include diaphragm with spermicide; sponge with spermicide; condom with spermicide; or intrauterine device with condom or spermicide. The following contraceptive methods are acceptable only when used with a condom and spermicide: birth control pills, birth control patches, vaginal ring, hormone under the skin, or hormone injections
• Postmenopausal females, defined as females who have had amenorrhea for at least 12 months either naturally or following cessation of all exogenous hormonal treatments and have a follicle stimulating hormone (FSH) level of \> 40 mIU/mL at Screening
• Females who have undergone surgical sterilization, including hysterectomy, bilateral oophorectomy, bilateral salpingectomy, tubal ligation, or tubal essure
• Males must agree to practice abstinence or use a condom with spermicide and refrain from sperm donation during the study and for 30 days after the final study visit
• Provide written informed consent
• Willing to comply with study restrictions

You may not qualify if:

• Pregnant or lactating woman
• Clinically significant comorbidity that would interfere with completion of the study procedures or objectives, or compromise the subject's safety
• Seated systolic blood pressure (BP) ≥ 150 mmHg or ≤ 90 mmHg or diastolic BP ≥ 95 mmHg
• Use of H1 receptor antagonists (i.e. antihistamines) within 5 days prior to Day 1
• Evidence of drug or alcohol abuse as determined by the Investigator within 6 months of Day 1
• Positive test result for drugs of abuse (with the exception of medically prescribed drugs) at Screening or on Day -1
• Treatment with an investigational agent within 30 days of Day 1 or within five half-lives of the investigational agent at Day 1 (whichever is longer)
• Congenital or acquired immunodeficiency syndrome
• Prior solid organ or bone marrow transplant
• Positive test for Hepatitis B (surface antigen), Hepatitis C, or human immunodeficiency virus (HIV) at Screening
• History of prior treatment for anthrax exposure or prior anthrax infection
• Prior immunization with any approved or investigational anthrax vaccine or prior treatment with an investigational anthrax treatment (i.e., ETI-204, raxibacumab, or anthrax immune globulin)
• Military personnel deployed in 1990 or after, unless the subject can provide documentation demonstrating they have not previously received any approved or investigational anthrax vaccine
• Use of systemic steroids, immunosuppressive agents, anticoagulants, or anti-arrhythmics within 1 year prior to Day 1. A single short course (i.e., less than 14 days) of systemic steroid therapy is allowed provided it concluded more than 6 months prior to Day 1
• Donation or loss of \> 500 mL of blood within 30 days or plasma within 7 days of Day 1

Sponsors & Collaborators

• Elusys Therapeutics: lead

Study Sites (1)

Covance Clinical Research Inc.

Dallas, Texas, 75247, United States

Location

Related Publications (1)

• Nagy CF, Leach TS, Hoffman JH, Czech A, Carpenter SE, Guttendorf R. Pharmacokinetics and Tolerability of Obiltoxaximab: A Report of 5 Healthy Volunteer Studies. Clin Ther. 2016 Sep;38(9):2083-2097.e7. doi: 10.1016/j.clinthera.2016.07.170. Epub 2016 Aug 24.

  PMID: 27568215 DERIVED

MeSH Terms

Conditions

Inhalation anthrax; Anthrax

Interventions

obiltoxaximab

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Director of Regulatory
• Organization: Elusys Therapeutics, Inc.

cdillon@elusys.com

973-808-0222

Study Officials

• Alex King, MD

  Covance

  PRINCIPAL INVESTIGATOR

• Lori Sieboldt, MD

  Covance Clinical Research - Evansville, IN

  PRINCIPAL INVESTIGATOR

• Debra Mandarino, MD

  Covance Research, Madison, WI

  PRINCIPAL INVESTIGATOR

• H. Frank Farmer, PhD, MD

  Covance Research - Daytona Beach, Fl

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 27, 2013
• Study Start: July 9, 2013
• Primary Completion: November 29, 2013
• Study Completion: November 29, 2013
• Last Updated: April 8, 2019
• Results First Posted: April 8, 2019

Record last verified: 2019-01

Locations

US (1)