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

Evergreen Therapeutics

Status and phase: Begins enrollment in 3 months; Phase 1

Conditions: Pre-eclampsia

Treatments: Drug: EG-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT07327255

EG-101-1.1

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Group 1: treatment sequences ABC+D

Experimental group

Description:

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)

Treatment:

Drug: EG-101

Group 2: treatment sequence: BCA+D

Experimental group

Description:

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)

Treatment:

Drug: EG-101

Group 3: treatment sequence: CAB+D

Experimental group

Description:

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)

Treatment:

Drug: EG-101