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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pre-eclampsia
• Intervention / Treatment: Drug: EG-101

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xin Du, Ph.D.; Phone Number: 240-406-4016; Email: david.du@egpharm.com
• Study Contact Backup: Name: Charles Lee, M.D., Ph.D.; Phone Number: 240-406-4016; Email: charles.lee@egpharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

1. Healthy adult female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit
2. 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.)
3. 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
4. Male subjects, are not enrolled into this study
5. 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:

1. Females who are pregnant, lactating, or likely to become pregnant during the study
2. History and/or recent evidence within 6 months prior to Screening of alcohol or drug/substance abuse disorder
3. Subjects with a history of hypersensitivity to Zanamivir or any component of study medication
4. History of clinically significant allergies including drug allergies or allergic bronchial asthma or related bronchospastic conditions
5. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: treatment sequences ABC+D; 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)	Drug: EG-101; EG-ZNMP-01 IV injection 10 mg/mL, 20 mL vial; Other Names: EG-ZNMP-01
Experimental: Group 2: treatment sequence: BCA+D; 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)	Drug: EG-101; EG-ZNMP-01 IV injection 10 mg/mL, 20 mL vial; Other Names: EG-ZNMP-01
Experimental: Group 3: treatment sequence: CAB+D; 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)	Drug: EG-101; EG-ZNMP-01 IV injection 10 mg/mL, 20 mL vial; Other Names: EG-ZNMP-01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Time to Maximum Concentration	Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
Cmax	Maximum Plasma Concentration	Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
AUC	Area Under the Plasma Concentration-time Curve	Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
CL/F	Apparent Plasma Clearance	Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
Vd/F	Apparent Volume of Distribution	Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
t½	Terminal Elimination Half-life	Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose
Ae	Cumulative Amount Excreted Unchanged in Urine	Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline through to post study Follow-up (up to 5 weeks)
Blood pressure		From screening throughout the study duration to post study Follow-up (up to 5 weeks)
Respiratory rate		From screening throughout the study duration to post study Follow-up (up to 5 weeks)
Pulse rate		From screening throughout the study duration to post study Follow-up (up to 5 weeks)
Body temperature		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).	At the screening day, Day 1 pre-dose and 6 hours post-dose
Prothrombin time (PT)	Clinical laboratory test of blood coagulation	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	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	On screening day, check-in day (D-1), and during post study Follow-up (up to 5 weeks)
Protein	Clinical laboratory test of urinalysis	On screening day, check-in day (D-1), and during post study Follow-up (up to 5 weeks)

Collaborators and Investigators

• Sponsor: Evergreen Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 25, 2025
• First Posted (Estimated): January 8, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Phase 1 Study
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: EG-101-1.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No