Clinical trial

Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single-Ascending Dose Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects

NCT02061358

Name

DMID 13-0001

Description

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.

Trial arms

Trial start

2014-07-01

Estimated PCD

2015-07-01

Trial end

2015-09-01

Status

Completed

Phase

Early phase I

Treatment

UV-4B 3 mg

Oral solution, single dose

Arms:

Cohort 1 - 3 mg UV-4B

UV-4B 10 mg

Oral solution, single dose

Arms:

Cohort 2 - 10 mg UV-4B

UV-4B 30 mg

Oral solution, single dose

Arms:

Cohort 3- 30 mg UV-4B

UV-4B 90 mg

Oral solution, single dose

Arms:

Cohort 4 - 90 mg UV-4B

UV-4B 180 mg

Oral solution, single dose

Arms:

Cohort 5 - 180 mg UV-4B

UV-4B 360 mg

Oral solution, single dose

Arms:

Cohort 6 - 360 mg UV-4B

UV-4B 720 mg

Oral solution, single dose

Arms:

Cohort 7 - 720 mg UV-4B

UV-4B 1000 mg

Oral solution, single dose

Arms:

Cohort 8 - 1000 mg UV-4B

Placebo

Oral solution, single dose

Arms:

Cohort 1 - 3 mg UV-4B, Cohort 2 - 10 mg UV-4B, Cohort 3- 30 mg UV-4B, Cohort 4 - 90 mg UV-4B, Cohort 5 - 180 mg UV-4B, Cohort 6 - 360 mg UV-4B, Cohort 7 - 720 mg UV-4B, Cohort 8 - 1000 mg UV-4B

Size

Primary endpoint

Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group

From time of the first dose administration through Day 9 ± 1

Subjects With Serious Adverse Event (SAEs) by Treatment Group

From time of the first dose administration through Day 9 ± 1

Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)

From time of the first dose administration through Day 9 ± 1

Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group

From time of the first dose administration through Day 9 ± 1

Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group

Day 9 ± 1

Eligibility criteria

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 64, 'type': 'ACTUAL'}}

Updated at

2024-03-18

1 organization

2 products

1 indication

Organization

Emergent Biosolutions

Product

UV-4B

Indication

viral infection

Product

Placebo