Testing the AVI-7100 Flu Drug in Healthy Volunteers

NCT01747148 | Completed Phase 1

• 2 other identifiers: 13002913-I-0029
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Influenza (flu) is a virus that causes people to get sick. Most of the time, the flu causes only a mild illness, but some people can become seriously ill or even die from it. Currently, some pills and inhaled powders can be used to treat the flu, but they only make flu symptoms end about a day sooner. More treatment choices for the flu are needed, especially for those who become seriously ill. Researchers want to test a new drug, AVI-7100, that might keep a person who takes it from having a more serious case of the flu. Objectives: \- To see how healthy adult volunteers tolerate the AVI-7100 anti-influenza drug. Eligibility: \- Healthy volunteers of normal weight between 18 and 60 years of age. Design:

• Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. A heart function test will also be performed.
• Participants will have either AVI-7100 or a placebo infusion. They will not know which infusion they have. . Participants will stay at the clinical center for a total of 8 hours after the infusion. Blood samples will be collected 1, 2, 4, and 8 hours after the end of the infusion
• Participants will return on Days 1, 2, 4, 10, and 28 after receiving the drug. Blood and urine samples will be collected. A heart function test will also be performed.
• There will be a second part of the study that is separate from the first one. Additional people will receive either AVI-7100 or placebo to test their reactions to a specific dose.

Conditions

Influenza

Keywords

Antisense; Influenza; IV Injection; RNA Based Therapeutic; RNA Interference

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of AVI-7100 in healthy adults, following single- or multiple-dose, intravenous administration at escalating dose-levels

  2 years

Secondary Outcomes (1)

• To evaluate the pharmacokinetics of intravenously administered AVI-7100 in healthy adults, following single- or multiple-dose, intravenous administration at escalating dose-levels

  2 years

Interventions

AVI-7100 versus placebo DRUG

dose-escalating AVI-7100 versus placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age greater than or equal to 18 years and less than or equal to 60 years
• Body mass index (BMI) of 19-32 kg/m(2)
• Estimated glomerular filtration rate greater than or equal to 90 mL/min at screening, calculated using the MDRD formula
• Subjects must agree to:
• Not take any prescription or OTC medications with the exception of Tylenol, vitamins, seasonal allergy medications, and/or contraceptive medications for a period 7 days prior and during study drug administration.
• Not consume any alcohol for a period 2 days prior to and during study drug administration.
• \. One of the following in order to avoid pregnancy:
• Females who are able to become pregnant (i.e., are not postmenopausal)
• have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 2 effective forms of contraception.
• From the date of the subject s signing of the informed consent form through 28 days after the last dose of study drug. At least one of the methods of contraception should be a barrier method.
• Males who have not undergone surgical sterilization and are sexually active with women must agree to use condoms plus have a partner use at least one additional effective form of contraception from the date of the subject s signing of the informed consent form through 28 days after the last dose of study drug.

You may not qualify if:

• Any chronic medical problem that requires daily oral medications (except Tylenol, oral contraceptives, vitamins, and seasonal allergy medications), or other medical history that in the opinion of the investigator significantly increases the risk associated with a phase I drug.
• History of cardiovascular disease or unexplained syncope
• Women who are breast-feeding.
• Positive urine or serum pregnancy test.
• Abnormal ECG
• defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table.
• evaluating PR interval, QTc interval and rhythm.
• Abnormal chemistry panel
• defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table
• evaluating only sodium \[Na\], potassium \[K\], serum bicarbonate \[total CO2\], creatinine, glucose,albumin, ALT, AST, ALKP, GGT, total bilirubin, LDH, and estimated GFR by the MDRD equation.
• Abnormal complete blood count (CBC)
• defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table
• \-- evaluating only the WBC (to include absolute neutrophil and lymphocyte counts), hemoglobin, hematocrit, and platelets.
• Abnormal urinalysis
• defined as any clinically significant baseline Grade 1 or greater toxicity

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team; Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, Gubareva LV, Xu X, Bridges CB, Uyeki TM. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009 Jun 18;360(25):2605-15. doi: 10.1056/NEJMoa0903810. Epub 2009 May 7.

  PMID: 19423869 BACKGROUND

• Abe T, Mizuta T, Hatta T, Miyano-Kurosaki N, Fujiwara M, Takai K, Shigeta S, Yokota T, Takaku H. Antisense therapy of influenza. Eur J Pharm Sci. 2001 Apr;13(1):61-9. doi: 10.1016/s0928-0987(00)00208-6.

  PMID: 11292569 BACKGROUND

• Mizuta T, Fujiwara M, Abe T, Miyano-Kurosaki N, Yokota T, Shigeta S, Takaku H. Inhibitory effects of an antisense oligonucleotide in an experimentally infected mouse model of influenza A virus. Biochem Biophys Res Commun. 2000 Dec 9;279(1):158-61. doi: 10.1006/bbrc.2000.3924.

  PMID: 11112432 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Richard T Davey, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2012
• First Posted: December 11, 2012
• Study Start: December 8, 2012
• Primary Completion: June 29, 2016
• Study Completion: June 29, 2016
• Last Updated: December 26, 2017

Record last verified: 2017-12-21

Locations

US (1)