Healthy Lactating WomenPhase 4NCT07618299
Evaluation of the Excretion of Fosfomycin Into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women
A Phase 4 study testing ZTI-01 in people with Healthy Lactating Women, run by Meitheal Pharmaceuticals, Inc. at 1 site in South Africa.
Trial summary
Evaluation of the Excretion of Fosfomycin into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Lactating Women
- What is being tested?
- ZTI-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Africa
- Study dates
- 22 Sep 2026to Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 45 years of age inclusive, at the time of signing the informed consent.
- Participant is a healthy lactating female, who is actively breastfeeding (including baby to breast, bottle feeding mother's expressed breast milk) and is at least 12 weeks postpartum of a healthy term (≥ 37 weeks gestational age) newborn infant (no medical complications) and not more than 1 years postpartum. Lactation must be well established prior to the day of admission to inpatient unit.
- Participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead ECG at screening.
- Participant is willing to temporarily discontinue breastfeeding their infant and discard all their breast milk for 5 consecutive days, including (day of admission to inpatient unit (Day -1), day of dosing while in the inpatient unit (Day 1), and 3 consecutive days after dose (including the day of discharge from the inpatient unit and 2 days at home; Days 2 to 4); and willing to store sufficient amount of breastmilk (e.g., breast milk pumped and stored in freezer before the day of admission), and/or infant formula to feed infant during these 5 consecutive days.
- Participant must not be in the process of weaning before admission to inpatient unit and have maintained an adequate breast milk supply (according to Investigator discretion) with regularly pumping or routine breastfeeding (e.g., pumping or feeding 3-4 times a day) at admission.
- Participant has a body mass index (BMI) within the range 18 to 35 kg/m2 (inclusive)
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- Participant is either sexually inactive (abstinent) or, if sexually active, must agree to use/practice one of the acceptable birth control methods listed in Section 10.3 beginning before or during the screening period prior to the first dose, throughout the inpatient stay, and for 3 days following the dose.
- Signed informed consent as described in Section 10.1.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Willingness to follow protocol defined restrictions and Investigator/staff instructions and protocol procedures.
- Agrees to use only the emollient or nipple cream recommended by the investigator for use during the sampling period, if needed.
Who cannot join
- Participant is pregnant or plans to become pregnant during the course of the study.
- Sensitivity to any of the study interventions, or components thereof, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- History or presence of cardiovascular, respiratory, psychiatric, metabolic, hepatic, renal, gastrointestinal, endocrinological, hematological, oncological, or neurological disorders determined to be clinically significant by the Investigator.
- History or presence of any condition that in the opinion of the Investigator would constitute a risk when taking the study intervention or interfere with the interpretation of data.
- History or presence of drug or alcohol abuse or current alcohol use > 21 units of alcohol per week (1 unit is equal to approximately 330 mL of beer, 1 small glass [200 mL] of wine, or 1 measure [25 mL] of spirits).
- History or regular use of tobacco- or nicotine-containing products within 6 months prior to screening with the exception of casual smokers (i.e., < 5 cigarettes per week).
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- Has history of mastitis within 30 days, breast cancer and/or has had a mastectomy or lumpectomy with the exception of a benign fibroma or lipoma removal at the investigator's discretion; and/or a clinically significant abnormality observed in either breast during a clinical breast exam at Screening or Admission (Day -1).
- Past or intended use of prescription medication within 14 days or over-the-counter medication including herbal medications within 7 days prior to dosing (apart from vitamin/mineral supplements or occasional paracetamol).
- Current enrollment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within 90 days or 5 half-lives (whichever is longer) before planned first dose of study intervention in this clinical study.
- Positive drug/alcohol screen at screening or Day -1. At screening visit, in case of a positive result the urine screen for drugs of abuse may be repeated once at the discretion of the Investigator.
- Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening; positive test results for hepatitis B surface antigen (HBsAg), immunoglobulin M (IgM) antibody to hepatitis B core antigen (anti-HBc), or hepatitis C virus (HCV Ab) antibodies at screening.
- Positive pregnancy test at screening or Day -1.
- Clinically significant vital signs, ECG findings, or laboratory abnormalities, including CrCl ≤ 50 mL/min.
- Has history of breast implants, breast augmentation, or breast reduction surgery.
- Unwilling to abstain from alcohol for 48 hours prior to dosing through the duration of confinement.
- Employees or close relatives of the contract service providers, the sponsor, 3rd party vendors or affiliates of the above mentioned parties.
- Vulnerable participants (e.g., persons in detention).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Meitheal Pharmaceuticals, Inc. Meitheal Pharmaceuticals, Inc. contact
South Africa1 site, 1 recruiting
- Recruiting
FARMOVS (Pty) Ltd
Bloemfontein, 9301
Meitheal Meitheal, (224) 443-4617, info@meithealpharma.com
About this study
Evaluation of the Excretion of Fosfomycin into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women
Read the detailed description
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
- Being tested
- ZTI-01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZTI-01Drug
Participants will receive a single intravenous dose of ZTI-01 (6 g)
| Study group | Role | What they receive |
|---|---|---|
| ZTI-01 | Other | Participants will receive single intravenous dose of ZTI-01 (6 g) Receives: Drug: ZTI-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve for drug concentrations in breast milk from time 0 to 24 hours (AUC0-24h,milk)
To evaluate the PK of ZTI-01 in breast milk in healthy lactating women following a single intravenous dose
Measured: 0-24 hours post dose
Maximum observed drug concentration in breast milk (Cmax,milk)
To evaluate the PK of ZTI-01 in breast milk in healthy lactating women following a single intravenous dose
Measured: 0-24 hours post dose
Time to reach the maximum observed drug concentration in breast milk (Tmax,milk)
To evaluate the PK of ZTI-01 in breast milk in healthy lactating women following a single intravenous dose
Measured: 0-24 hours post dose
Average drug concentration in breast milk (Cave,milk), calculated as AUC₀-24h, milk divided by Tau (τ)
To evaluate the PK of ZTI-01 in breast milk in healthy lactating women following a single intravenous dose
Measured: 0-24 hours post dose
Total amount of drug in breast milk over a period of 24 hours (Ammilk, mg/day) following a single dose
To evaluate the PK of ZTI-01 in breast milk in healthy lactating women following a single intravenous dose
Measured: 0-24 hours post dose
Secondary outcomes (3)
Estimated daily infant dosage (EDID, mg/kg/day)
To estimate daily infant dose of ZTI-01 via breast milk
Measured: 0-24 hours post dose
Relative infant dose (RID, %)
To estimate daily infant dose of ZTI-01 via breast milk
Measured: 0-24 hours post dose
Adverse event (AE) assessments
To assess the safety and tolerability of ZTI-01 in healthy lactating women
Measured: Baseline (Day 1) to End of Study (Day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start22 Sep 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Lactating WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meitheal Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618299
- Sponsor's protocol ID
- ZTI-01-401
- Status last verified
- Sep 2026
- First submitted
- 8 May 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Excretion of Fosfomycin Into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women
- ClinicalTrials.gov ID
- NCT07618299
- Acronym / sponsor ID
- ZTI-01-401
- Conditions
- Healthy Lactating Women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Meitheal Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the Excretion of Fosfomycin into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women
Detailed description
Evaluation of the Excretion of Fosfomycin into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZTI-01 | Other | Drug: ZTI-01Participants will receive single intravenous dose of ZTI-01 (6 g) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Participant must be 18 to 45 years of age inclusive, at the time of signing the informed consent.
- Participant is a healthy lactating female, who is actively breastfeeding (including baby to breast, bottle feeding mother's expressed breast milk) and is at least 12 weeks postpartum of a healthy term (≥ 37 weeks gestational age) newborn infant (no medical complications) and not more than 1 years postpartum. Lactation must be well established prior to the day of admission to inpatient unit.
- Participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead ECG at screening.
- Participant is willing to temporarily discontinue breastfeeding their infant and discard all their breast milk for 5 consecutive days, including (day of admission to inpatient unit (Day -1), day of dosing while in the inpatient unit (Day 1), and 3 consecutive days after dose (including the day of discharge from the inpatient unit and 2 days at home; Days 2 to 4); and willing to store sufficient amount of breastmilk (e.g., breast milk pumped and stored in freezer before the day of admission), and/or infant formula to feed infant during these 5 consecutive days.
- Participant must not be in the process of weaning before admission to inpatient unit and have maintained an adequate breast milk supply (according to Investigator discretion) with regularly pumping or routine breastfeeding (e.g., pumping or feeding 3-4 times a day) at admission.
Key exclusion criteria (17 listed)
- Participant is pregnant or plans to become pregnant during the course of the study.
- Sensitivity to any of the study interventions, or components thereof, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- History or presence of cardiovascular, respiratory, psychiatric, metabolic, hepatic, renal, gastrointestinal, endocrinological, hematological, oncological, or neurological disorders determined to be clinically significant by the Investigator.
- History or presence of any condition that in the opinion of the Investigator would constitute a risk when taking the study intervention or interfere with the interpretation of data.
- History or presence of drug or alcohol abuse or current alcohol use > 21 units of alcohol per week (1 unit is equal to approximately 330 mL of beer, 1 small glass [200 mL] of wine, or 1 measure [25 mL] of spirits).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZTI-01Participants will receive a single intravenous dose of ZTI-01 (6 g) | Drug | ZTI-01 |
Primary outcome
Area under the concentration-time curve for drug concentrations in breast milk from time 0 to 24 hours (AUC0-24h,milk)
Time frame: 0-24 hours post dose
To evaluate the PK of ZTI-01 in breast milk in healthy lactating women following a single intravenous dose
Maximum observed drug concentration in breast milk (Cmax,milk)
Time frame: 0-24 hours post dose
To evaluate the PK of ZTI-01 in breast milk in healthy lactating women following a single intravenous dose
Time to reach the maximum observed drug concentration in breast milk (Tmax,milk)
Time frame: 0-24 hours post dose
To evaluate the PK of ZTI-01 in breast milk in healthy lactating women following a single intravenous dose
Average drug concentration in breast milk (Cave,milk), calculated as AUC₀-24h, milk divided by Tau (τ)
Time frame: 0-24 hours post dose
To evaluate the PK of ZTI-01 in breast milk in healthy lactating women following a single intravenous dose
Total amount of drug in breast milk over a period of 24 hours (Ammilk, mg/day) following a single dose
Time frame: 0-24 hours post dose
To evaluate the PK of ZTI-01 in breast milk in healthy lactating women following a single intravenous dose
3 secondary outcomes
Estimated daily infant dosage (EDID, mg/kg/day)
Time frame: 0-24 hours post dose
Relative infant dose (RID, %)
Time frame: 0-24 hours post dose
Adverse event (AE) assessments
Time frame: Baseline (Day 1) to End of Study (Day 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meitheal Pharmaceuticals, Inc. Meitheal Pharmaceuticals, Inc. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ZTI-01 in people with Healthy Lactating Women, run by Meitheal Pharmaceuticals, Inc. at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meitheal Pharmaceuticals, Inc. Meitheal Pharmaceuticals, Inc. ((224) 443-4617, info@meithealpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve for drug concentrations in breast milk from time 0 to 24 hours (AUC0-24h,milk) (time frame: 0-24 hours post dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.