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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EG-101 | Drug | EG-ZNMP-01 IV injection 10 mg/mL, 20 mL vial |
|
| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
The study enrolls only biological females and will accept only cisgender women.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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Randomized, Cross-over, Single-Center, Single Dose Fasted Study
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| 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) |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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