Pre-eclampsiaPhase 1NCT07327255
Pharmacokinetic Study to Evaluate Safety and Tolerability of EG-101 in Healthy Female Volunteers as a Safety Lead-In for Dosing in Pregnant Women With Severe Pre-eclampsia
A Phase 1 study testing EG-101 in people with Pre-eclampsia, run by Evergreen Therapeutics, Inc..
Trial summary
Preeclampsia is one of the leading causes of maternal and fetal death. It is a syndrome of pregnant women and is usually characterized by new onset of hypertension and proteinuria after 20 weeks of gestation. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-eclampsia
- What is being tested?
- EG-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Mar 2027
- Phase
- Phase 1
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit
- Body mass index (BMI) ≥18.5 to ≤32 kg/m2 at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared.)
- All female subjects must be nonpregnant, nonlactating and either postmenopausal, surgically sterile, or using contraceptive regimens more than 3 months. All females must have a negative serum pregnancy test at Screening and Check-in Visit. Effective methods of contraception include a dual method of contraception: condom with spermicide in conjunction with use of an intrauterine device (IUD), condom with spermicide in conjunction with use of a diaphragm, condom with birth control patch or vaginal ring, or condom with oral, injectable, or implanted contraceptive. Surgical sterility is documented through documented: hysterectomy, partial hysterectomy, bilateral oophorectomy, or bilateral tubal ligation at least 6 months prior to Screening. Postmenopausal sterility is documented by absence of menses for at least 12 months prior to Screening plus serum FSH ≥40 mIU/mL and estradiol <30 pg/mL at screening
- Male subjects, are not enrolled into this study
- Medically healthy on the basis of medical history, and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems), as determined by the Investigator at Screening and each Check-In Visit
Who cannot join
- Females who are pregnant, lactating, or likely to become pregnant during the study
- History and/or recent evidence within 6 months prior to Screening of alcohol or drug/substance abuse disorder
- Subjects with a history of hypersensitivity to Zanamivir or any component of study medication
- History of clinically significant allergies including drug allergies or allergic bronchial asthma or related bronchospastic conditions
- Subjects who have history of unexplained syncope or fainting or a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia or dehydration
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I, Randomized, Cross-over, Single-Center, Single Dose Fasted Study of EG-101 IV Injection (EG-ZNMP-01) in Healthy Volunteers to Serve as a Safety Lead-In for Dosing in Pregnant Women With Severe Pre-eclampsia
Preeclampsia is one of the leading causes of maternal and fetal death. It is a syndrome of pregnant women and is usually characterized by new onset of hypertension and proteinuria after 20 weeks of gestation. This disease is a multisystem disorder affects most maternal organs, predominantly the vascular, renal, hepatic, cerebral and coagulation systems. While hypertension is almost always a symptom of this disease, preeclampsia is not the same as essential hypertension.
This is a single-center, randomized, open-label, 4 period, 3-way crossover, single dose fasted study to evaluate the safety, tolerability and pharmacokinetics of four ascending doses of the EG-101 IV injection in healthy volunteers.
Twenty-four subjects in total, with eight subjects randomly assigned to one of three different sequences for variation of doses under fasted conditions. Dosing duration is approximately 4 weeks and followed by the follow-up for each subject.
- Conditions
- Pre-eclampsia
- Being tested
- EG-101
- Keywords
- Phase 1 Study
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EG-101Drug
Also called EG-ZNMP-01
EG-ZNMP-01 IV injection 10 mg/mL, 20 mL vial
| Study group | Role | What they receive |
|---|---|---|
| Group 1: treatment sequences ABC+D | Experimental | Period 1
Drug: EG-101 100 mg IVPB once (Level A)
Period 2
Drug: EG-101 400 mg IVPB once (Level B)
Period 3
Drug: EG-101 600 mg IVPB once (Level C)
Period 4
Drug: EG-101 600 mg IVPB twice, 8 hours apart (Level D) Receives: Drug: EG-101 |
| Group 2: treatment sequence: BCA+D | Experimental | Period 1
Drug: EG-101 400 mg IVPB once (Level B)
Period 2
Drug: EG-101 600 mg IVPB once (Level C)
Period 3
Drug: EG-101 100 mg IVPB once (Level A)
Period 4
Drug: EG-101 600 mg IVPB twice, 8 hours apart (Level D) Receives: Drug: EG-101 |
| Group 3: treatment sequence: CAB+D | Experimental | Period 1
Drug: EG-101 600 mg IVPB once (Level C)
Period 2
Drug: EG-101 100 mg IVPB once (Level A)
Period 3
Drug: EG-101 400 mg IVPB once (Level B)
Period 4
Drug: EG-101 600 mg IVPB twice, 8 hours apart (Level D) Receives: Drug: EG-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax
Time to Maximum Concentration
Measured: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
Cmax
Maximum Plasma Concentration
Measured: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
AUC
Area Under the Plasma Concentration-time Curve
Measured: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
CL/F
Apparent Plasma Clearance
Measured: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
Vd/F
Apparent Volume of Distribution
Measured: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
t½
Terminal Elimination Half-life
Measured: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
Ae
Cumulative Amount Excreted Unchanged in Urine
Measured: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
Secondary outcomes (10)
Incidence of reported adverse events
To assess the safety and tolerability of EG-101 across 4 ascending dose levels under fasting conditions in healthy women including but not limited to the adverse events.
Measured: From baseline through to post study Follow-up (up to 5 weeks)
Blood pressure
Measured: From screening throughout the study duration to post study Follow-up (up to 5 weeks)
Respiratory rate
Measured: From screening throughout the study duration to post study Follow-up (up to 5 weeks)
Pulse rate
Measured: From screening throughout the study duration to post study Follow-up (up to 5 weeks)
Body temperature
Measured: From screening throughout the study duration to post study Follow-up (up to 5 weeks)
12-lead electrocardiograms (ECG)
To assess the safety and tolerability of EG-101 across 4 ascending dose levels under fasting conditions in healthy women including but not limited to the resting 12-lead electrocardiograms (ECG) assessment (includes the overall interpretation, PR interval, QRS duration, RR, QT, and QTcF intervals).
Measured: At the screening day, Day 1 pre-dose and 6 hours post-dose
Prothrombin time (PT)
Clinical laboratory test of blood coagulation
Measured: On screening day, check-in day (D-1), and during post study Follow-up (up to 5 weeks)
White Blood Cell count
Clinical laboratory test of hematology
Measured: On screening day, check-in day (D-1), and during post study Follow-up (up to 5 weeks)
Albumin
Clinical laboratory test of serum chemistry
Measured: On screening day, check-in day (D-1), and during post study Follow-up (up to 5 weeks)
Protein
Clinical laboratory test of urinalysis
Measured: On screening day, check-in day (D-1), and during post study Follow-up (up to 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study startJun 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-eclampsiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Cross-over, Single-Center, Single Dose Fasted Study
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evergreen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327255
- Sponsor's protocol ID
- EG-101-1.1
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Cross-over, Single-Center, Single Dose Fasted Study of EG-101 IV Injection (EG-ZNMP-01) in Healthy Volunteers to Serve as a Safety Lead-In for Dosing in Pregnant Women With Severe Pre-eclampsia
- ClinicalTrials.gov ID
- NCT07327255
- Acronym / sponsor ID
- EG-101-1.1
- Conditions
- Pre-eclampsia
- Keywords
- Phase 1 Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Evergreen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Jan 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.
Preeclampsia is one of the leading causes of maternal and fetal death. It is a syndrome of pregnant women and is usually characterized by new onset of hypertension and proteinuria after 20 weeks of gestation. This disease is a multisystem disorder affects most maternal organs, predominantly the vascular, renal, hepatic, cerebral and coagulation systems. While hypertension is almost always a symptom of this disease, preeclampsia is not the same as essential hypertension.
This is a single-center, randomized, open-label, 4 period, 3-way crossover, single dose fasted study to evaluate the safety, tolerability and pharmacokinetics of four ascending doses of the EG-101 IV injection in healthy volunteers.
Twenty-four subjects in total, with eight subjects randomly assigned to one of three different sequences for variation of doses under fasted conditions. Dosing duration is approximately 4 weeks and followed by the follow-up for each subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, Cross-over, Single-Center, Single Dose Fasted Study
| Arm | Type | Receives |
|---|---|---|
| Group 1: treatment sequences ABC+D | Experimental | Drug: EG-101Period 1 Drug: EG-101 100 mg IVPB once (Level A) Period 2 Drug: EG-101 400 mg IVPB once (Level B) Period 3 Drug: EG-101 600 mg IVPB once (Level C) Period 4 Drug: EG-101 600 mg IVPB twice, 8 hours apart (Level D) |
| Group 2: treatment sequence: BCA+D | Experimental | Drug: EG-101Period 1 Drug: EG-101 400 mg IVPB once (Level B) Period 2 Drug: EG-101 600 mg IVPB once (Level C) Period 3 Drug: EG-101 100 mg IVPB once (Level A) Period 4 Drug: EG-101 600 mg IVPB twice, 8 hours apart (Level D) |
| Group 3: treatment sequence: CAB+D | Experimental | Drug: EG-101Period 1 Drug: EG-101 600 mg IVPB once (Level C) Period 2 Drug: EG-101 100 mg IVPB once (Level A) Period 3 Drug: EG-101 400 mg IVPB once (Level B) Period 4 Drug: EG-101 600 mg IVPB twice, 8 hours apart (Level D) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit
- Body mass index (BMI) ≥18.5 to ≤32 kg/m2 at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared.)
- All female subjects must be nonpregnant, nonlactating and either postmenopausal, surgically sterile, or using contraceptive regimens more than 3 months. All females must have a negative serum pregnancy test at Screening and Check-in Visit. Effective methods of contraception include a dual method of contraception: condom with spermicide in conjunction with use of an intrauterine device (IUD), condom with spermicide in conjunction with use of a diaphragm, condom with birth control patch or vaginal ring, or condom with oral, injectable, or implanted contraceptive. Surgical sterility is documented through documented: hysterectomy, partial hysterectomy, bilateral oophorectomy, or bilateral tubal ligation at least 6 months prior to Screening. Postmenopausal sterility is documented by absence of menses for at least 12 months prior to Screening plus serum FSH ≥40 mIU/mL and estradiol <30 pg/mL at screening
- Male subjects, are not enrolled into this study
- Medically healthy on the basis of medical history, and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems), as determined by the Investigator at Screening and each Check-In Visit
Key exclusion criteria (5 listed)
- Females who are pregnant, lactating, or likely to become pregnant during the study
- History and/or recent evidence within 6 months prior to Screening of alcohol or drug/substance abuse disorder
- Subjects with a history of hypersensitivity to Zanamivir or any component of study medication
- History of clinically significant allergies including drug allergies or allergic bronchial asthma or related bronchospastic conditions
- Subjects who have history of unexplained syncope or fainting or a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia or dehydration
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 |
|---|---|---|
| EG-101Also: EG-ZNMP-01EG-ZNMP-01 IV injection 10 mg/mL, 20 mL vial | Drug | Group 1: treatment sequences ABC+D, Group 2: treatment sequence: BCA+D, Group 3: treatment sequence: CAB+D |
Primary outcome
Tmax
Time frame: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
Time to Maximum Concentration
Cmax
Time frame: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
Maximum Plasma Concentration
AUC
Time frame: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
Area Under the Plasma Concentration-time Curve
CL/F
Time frame: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
Apparent Plasma Clearance
Vd/F
Time frame: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
Apparent Volume of Distribution
t½
Time frame: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
Terminal Elimination Half-life
Ae
Time frame: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
Cumulative Amount Excreted Unchanged in Urine
10 secondary outcomes
Incidence of reported adverse events
Time frame: From baseline through to post study Follow-up (up to 5 weeks)
Blood pressure
Time frame: From screening throughout the study duration to post study Follow-up (up to 5 weeks)
Respiratory rate
Time frame: From screening throughout the study duration to post study Follow-up (up to 5 weeks)
Pulse rate
Time frame: From screening throughout the study duration to post study Follow-up (up to 5 weeks)
Body temperature
Time frame: From screening throughout the study duration to post study Follow-up (up to 5 weeks)
12-lead electrocardiograms (ECG)
Time frame: At the screening day, Day 1 pre-dose and 6 hours post-dose
Prothrombin time (PT)
Time frame: On screening day, check-in day (D-1), and during post study Follow-up (up to 5 weeks)
White Blood Cell count
Time frame: On screening day, check-in day (D-1), and during post study Follow-up (up to 5 weeks)
Albumin
Time frame: On screening day, check-in day (D-1), and during post study Follow-up (up to 5 weeks)
Protein
Time frame: On screening day, check-in day (D-1), and during post study Follow-up (up to 5 weeks)
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 12 Jan 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EG-101 in people with Pre-eclampsia, run by Evergreen Therapeutics, Inc..
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xin Du, Ph.D. (240-406-4016, david.du@egpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tmax (time frame: Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose). The study lists 7 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 12 Jan 2026.