Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers

PHASE1RecruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

September 29, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Cardiovascular Disease
Interventions
BIOLOGICAL

Fx-5A peptide complex

subject will receive a slow I.V. infusion of the Fx-5A peptide complex as described in Table 1. Five to 10 mL of blood will be collected at 30min (+/- 5min\*), 1h (+/- 10min\*), 2h (+/- 10min\*), 4h (+/- 15min\*), 8h (+/- 30min\*), 12h (+/- 30min\*), and 24h (+/- 30min\*) for laboratory tests and to be stored for research tests. The patient will be dismissed, as inpatient, 24-36 hours after the beginning of the treatment.

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH