Overview
This is a Phase I, first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of ascending doses of CBP-4888.
Description
This study will involve female subjects meeting all inclusion criteria and no exclusion criteria. Cohorts of CBP-4888 are planned to be investigated in a sequential dose-escalation manner. Each cohort of subjects will be randomized to CBP-4888 to placebo and administered a single subcutaneous dose.
Eligibility
Inclusion Criteria:
- Healthy non-pregnant female subjects
- Body mass index (BMI) ≥ 18.5 and ≤ 35.0 kg/m2
- Medically healthy, defined as having no clinically significant abnormal screening results including clinical laboratory evaluations, medical history, vital signs, ECG, and physical examination as deemed by the Investigator.
Exclusion Criteria:
- Screening blood pressure < 100/60 mmHg or > 140/90 mmHg
- Screening heart rate that is < 40 bpm or > 99 bpm
- Clinically significant ECG abnormality at screening
- Used prescription medication within 14 days prior to dosing
- Used over the counter (OTC) medications (including herbal products, nutritional supplements, dietary supplements, and/or vitamins) within 7 days prior to dosing
- Donated blood or had significant blood loss within 56 days prior to dosing
