A Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ENA-001 Administered as Intravenous (IV) and Intramuscular (IM) Doses
Enalare Therapeutics Inc.
Summary
This study is a Phase I clinical trial to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) profiles with single intravenous (IV) and intramuscular (IM) doses of ENA-001.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedules. 2. Male and female, \>18 to ≤55 years of age. 3. Subject must weigh ≥50 to ≤100 kg. 4. Subjects must have Body Mass Index \[weight/height2 (kg/m2)\] between 18 to 30 kg/m2 (inclusive). 5. Have no clinical or electrocardiographic signs of ischemic heart disease as determined by the Investigator with normal cardiac intervals appropriate for their gender. The Screening 12 lead electrocardiogram (ECG) conduction intervals must be within gender specific nor…
Interventions
- DrugENA-001
Concentration for ENA-001 IV formulation is 10 mg/mL. Concentration for ENA 001 IM formulation is 30 mg/mL.
- DrugPlacebo Comparator
Placebo comes in 5 mL/vial. Placebo matches ENA-001 injection; however, no ENA-001 is included.
Locations (3)
- South Florida Research Phase I-IVMiami, Florida
- Dr. Vince Clinical ResearchOverland Park, Kansas
- ClinilabsEatontown, New Jersey