Pre-eclampsia
Conditions
Keywords
Phase 1 Study
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.
Interventions
DRUGEG-101
EG-ZNMP-01 IV injection 10 mg/mL, 20 mL vial
Sponsors
Evergreen Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, Cross-over, Single-Center, Single Dose Fasted Study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose | Time to Maximum Concentration |
| Cmax | Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose | Maximum Plasma Concentration |
| AUC | Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose | Area Under the Plasma Concentration-time Curve |
| CL/F | Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose | Apparent Plasma Clearance |
| Vd/F | Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose | Apparent Volume of Distribution |
| t½ | Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose | Terminal Elimination Half-life |
| Ae | Day 1 pre-dose and at multiple timepoints (up to 32 hours) post-dose | Cumulative Amount Excreted Unchanged in Urine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| White Blood Cell count | On screening day, check-in day (D-1), and during post study Follow-up (up to 5 weeks) | Clinical laboratory test of hematology |
| Incidence of reported adverse events | From baseline through to post study Follow-up (up to 5 weeks) | 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. |
| Protein | On screening day, check-in day (D-1), and during post study Follow-up (up to 5 weeks) | Clinical laboratory test of urinalysis |
| Albumin | On screening day, check-in day (D-1), and during post study Follow-up (up to 5 weeks) | Clinical laboratory test of serum chemistry |
| 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) | At the screening day, Day 1 pre-dose and 6 hours post-dose | 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). |
| Prothrombin time (PT) | On screening day, check-in day (D-1), and during post study Follow-up (up to 5 weeks) | Clinical laboratory test of blood coagulation |
Contacts
Primary ContactXin Du, Ph.D.
Backup ContactCharles Lee, M.D., Ph.D.
Outcome results
None listed