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

NCT07327255 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: EG-101-1.1
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

Phase 1 Study

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (10)

• Incidence of reported 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)

Study Arms (3)

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)

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)

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)

Drug: EG-101

Interventions

EG-101 DRUG

EG-ZNMP-01 IV injection 10 mg/mL, 20 mL vial

Also known as: EG-ZNMP-01

Group 1: treatment sequences ABC+D; Group 2: treatment sequence: BCA+D; Group 3: treatment sequence: CAB+D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: The study enrolls only biological females and will accept only cisgender women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Evergreen Therapeutics, Inc.: lead

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Xin Du, Ph.D.

CONTACT

240-406-4016; david.du@egpharm.com

Charles Lee, M.D., Ph.D.

CONTACT

240-406-4016; charles.lee@egpharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Cross-over, Single-Center, Single Dose Fasted Study

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 8, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2025-12