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.
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
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
Crossover
EG-101
DrugEG-ZNMP-01 IV injection 10 mg/mL, 20 mL vial
Tmax
Time to Maximum Concentration
Cmax
Maximum Plasma Concentration
AUC
Area Under the Plasma Concentration-time Curve
CL/F
Apparent Plasma Clearance
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.
Blood pressure
Respiratory rate
Pulse rate
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