Enalare Therapeutics Inc.
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.
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…
Concentration for ENA-001 IV formulation is 10 mg/mL. Concentration for ENA 001 IM formulation is 30 mg/mL.
Placebo comes in 5 mL/vial. Placebo matches ENA-001 injection; however, no ENA-001 is included.
Arctuva estimate
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