Evaluation of the Excretion of Fosfomycin Into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women
NCT07618299 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-06-01
Summary
Evaluation of the Excretion of Fosfomycin into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women
Conditions
- Healthy Lactating Women
Interventions
- DRUG
-
ZTI-01
Participants will receive a single intravenous dose of ZTI-01 (6 g)
Sponsors & Collaborators
-
Meitheal Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2027-08-31
- Completion
- 2027-08-31
- FDA Drug
- Yes
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