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Ascending Dose Study of the Safety of AB-SA01 When Topically Applied to Intact Skin of Healthy Adults

NCT02757755 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-08-31

No results posted yet for this study

Summary

This study will examine the safety of ascending doses of AB-SA01 when topically applied to intact skin of healthy adults.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

AB-SA01 (10^8 PFU per phage)

Gauze pads will be saturated with AB-SA01 and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.

BIOLOGICAL

AB-SA01 (10^9 PFU per phage)

Gauze pads will be saturated with AB-SA01 and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.

BIOLOGICAL

Placebo (for Cohort 10^8)

Gauze pads will be saturated with Placebo and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.

BIOLOGICAL

Placebo (for Cohort 10^9)

Gauze pads will be saturated with Placebo and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • Armata Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey Livezey, MD · Walter Reed Army Institute of Research (WRAIR)

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02757755 on ClinicalTrials.gov