NCT05351671 - A Clinical Study to Determine the Safety, Tolerability and Effect of RLS-0071 Doses When Given to Healthy Adults After Inhaling LPS | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 23, 2022

Primary Completion Date

September 21, 2022

Study Completion Date

September 21, 2022

Conditions

Healthy

Interventions

DRUG

RLS-0071 (10 mg/kg intravenously every 8 hours for total of 3 doses)

After challenge with inhaled LPS, subjects will receive IV infusion of RLS-0071 at 10 mg/kg every 8 hours for total of 3 doses.

DRUG

RLS-0071 (loading dose of 120 mg/kg followed by 40 mg/kg every 8 hours for 2 additional doses)

After challenge with inhaled LPS, subjects will receive IV infusion of RLS-0071 at a loading dose of 120 mg/kg followed by 40 mg/kg every 8 hours for 2 additional doses.

DRUG

Placebo (saline dosed every 8 hours for a total of 3 doses)

After challenge with inhaled LPS, subjects will receive IV infusion of placebo (saline) dosed every 8 hours for a total of 3 doses.

Trial Locations (1)

30625

Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Hanover