NCT05315921 - Study of OsrhAAT or Placebo in Healthy Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 22, 2022

Primary Completion Date

March 31, 2023

Study Completion Date

June 30, 2023

Conditions

Emphysema Secondary to Congenital AATD

Interventions

DRUG

OsrhAAT 1 mg/kg IV

"Drug: OsrhAAT 1 mg/kg IV A single dose of OsrhAAT 1 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg.~Placebo: Normal Saline (0.9% Sodium Chloride)"

DRUG

OsrhAAT 3 mg/kg IV

"Drug: OsrhAAT 3 mg/kg IV A single dose of OsrhAAT 3 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg.~Placebo: Normal Saline (0.9% Sodium Chloride)"

DRUG

OsrhAAT 10 mg/kg IV

"Drug: : OsrhAAT 10 mg/kg IV A single dose of OsrhAAT 10 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg.~Placebo: Normal Saline (0.9% Sodium Chloride)"

DRUG

OsrhAAT 20 mg/kg IV

"Drug: OsrhAAT 20 mg/kg IV A single dose of OsrhAAT 20 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg.~Placebo: Normal Saline (0.9% Sodium Chloride)"

DRUG

OsrhAAT 40 mg/kg IV

"Drug: OsrhAAT 40 mg/kg IV A single dose of OsrhAAT 40 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg.~Placebo: Normal Saline (0.9% Sodium Chloride)"

DRUG

OsrhAAT 60 mg/kg IV

"Drug: OsrhAAT 60 mg/kg IV A single dose of OsrhAAT 60 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg.~Placebo: Normal Saline (0.9% Sodium Chloride)"

Trial Locations (1)

90630

RECRUITING

Altasciences, Cypress