Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects

Emergent BioSolutions

Status and phase: Completed; Phase 1

Conditions: Viral Infection

Treatments: Drug: UV-4B 180 mg; Drug: UV-4B 3 mg; Drug: UV-4B 1000 mg; Drug: UV-4B 30 mg; Drug: UV-4B 720 mg; Drug: UV-4B 90 mg; Drug: Placebo; Drug: UV-4B 10 mg; Drug: UV-4B 360 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02061358

DMID 13-0001

UV-DEN-0001

KQA71264

Details and patient eligibility

About

The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of UV-4B in healthy subjects.

Full description

The causative agent of dengue fever is Dengue Virus (DENV), a member of the flavivirus genus. There are four DENV serotypes. Infection with one serotype results in lifelong immunity against that serotype, but only limited short-term cross-protection from infection with the other serotypes. Immunity to one serotype has a downside as subsequent infections by other serotypes increase the risk of developing more severe forms of dengue, which includes the most lethal form of the disease, dengue hemorrhagic fever. Traditional epidemiologic and serologic-based estimates suggest a range of 50 to 100 million DENV infections per year distributed over 100 countries. Recent cartographic-based modeling studies suggest that up to 390 million of dengue infections per year, of which 96 million are associated with clinical symptoms.

Enrollment: 64 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects
• Women: non-pregnant, non-lactating; if of childbearing potential, on specified contraception measures during the study period
• Men: using barrier contraception measures during the study period

Exclusion criteria

• Health conditions
• Taking prescription and non-prescription drugs (exceptions: acetaminophen, vitamins, hormonal birth control)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

64 participants in 8 patient groups

Cohort 1 - 3 mg UV-4B

Experimental group

Description:

Subjects receiving UV-4B 3 mg oral solution or placebo

Treatment:

Drug: Placebo

Drug: UV-4B 3 mg

Cohort 2 - 10 mg UV-4B

Experimental group

Description:

Subjects receiving UV-4B 10 mg oral solution or placebo

Treatment:

Drug: Placebo

Drug: UV-4B 10 mg

Cohort 3- 30 mg UV-4B

Experimental group

Description:

Subjects receiving UV-4B 30 mg oral solution or placebo

Treatment:

Drug: UV-4B 30 mg

Drug: Placebo

Cohort 4 - 90 mg UV-4B

Experimental group

Description:

Subjects receiving UV-4B 90 mg oral solution or placebo

Treatment:

Drug: Placebo

Drug: UV-4B 90 mg

Cohort 5 - 180 mg UV-4B

Experimental group

Description:

Subjects receiving UV-4B 180 mg oral solution or placebo

Treatment:

Drug: Placebo

Drug: UV-4B 180 mg

Cohort 6 - 360 mg UV-4B

Experimental group

Description:

Subjects receiving UV-4B 360 mg oral solution or placebo

Treatment:

Drug: UV-4B 360 mg

Drug: Placebo

Cohort 7 - 720 mg UV-4B

Experimental group

Description:

Subjects receiving UV-4B 720 mg oral solution or placebo

Treatment:

Drug: UV-4B 720 mg

Drug: Placebo

Cohort 8 - 1000 mg UV-4B

Experimental group

Description:

Subjects receiving UV-4B 1000 mg oral solution or placebo

Treatment:

Drug: Placebo

Drug: UV-4B 1000 mg