First-in-human, Randomized, Placebo-controlled, Double-blind, Dose-escalation Study of the Safety and Immunogenicity of NasoShield

Altimmune, Inc.2 sites in 1 country145 target enrollmentJanuary 18, 2018

ConditionsHealthy Volunteers

InterventionsNasoShield Placebo BioThrax

Overview

Phase: Phase 1
Intervention: NasoShield
Conditions: Healthy Volunteers
Sponsor: Altimmune, Inc.
Enrollment: 145
Locations: 2
Primary Endpoint: Reactogenicity
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18 to 49 years of age.

Detailed Description

This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18 to 49 years of age. Subjects will be screened within 28 days of randomization (Day 1). The study is comprised of 2 parts: * Part A: Approximately 120 subjects who meet all inclusion and no exclusion criteria and provide written informed consent will be enrolled into 4 sequential cohorts of 30 subjects each defined by the NasoShield dose (1×108, 1×109, 1×1010, and 1×1011 vp). Within each cohort (and the sentinel group in the first dose cohort), subjects will be randomized in a 4:1:1 ratio to receive 1 intranasal dose of NasoShield (Day 1), 1 intranasal dose of placebo (Day 1), or 3 subcutaneous 0.5 mL doses of BioThrax 14 days apart (Days 1, 15, and 29). NasoShield and placebo will be administered in a double-blind fashion, and BioThrax will be administered in an open-label fashion. * Part B: Approximately 25 subjects who meet all inclusion and no exclusion criteria and provide written informed consent will be randomized in a 4:1 ratio to receive 2 intranasal doses of NasoShield at the highest well tolerated dose from Part A or placebo 21 days apart (Days 1 and 22). NasoShield and placebo will be administered in a double-blind fashion. Subjects will return to the investigational site for multiple visits through Day 361. At each visit, the subject will be asked about the interim medical history and use of any medications, and safety and immunogenicity assessments will be performed.

Registry

clinicaltrials.gov

Start Date

January 18, 2018

End Date

May 13, 2019

Last Updated

10 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Altimmune, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men and women 18 to 49 years of age, inclusive
•Good general health status as determined by the Investigator
•Adequate venous access for repeated phlebotomies
•Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Creatine kinase or bilirubin may be Grade 2 if associated with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant due to vigorous exercise or Gilbert's syndrome
•Negative drug and alcohol screen at Screening and predose on Day 1
•For women who have not been surgically sterilized and do not have laboratory confirmation of postmenopausal status, negative pregnancy test
•Willingness to practice a highly effective method of contraception: abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization (hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD), or consistent use of a barrier method (eg, condom, diaphragm) with spermicide for 28 days after the last IP dose
•Willingness to participate and comply with all aspects of the study through the entire study period, including nasopharyngeal swabs and blood and urine samples
•Provision of written informed consent
•Exclusion Criteria