The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of SRK-001 in Healthy Participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
PRA Health Sciences
Groningen, Netherlands
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)
Number of participants with one or more TEAEs and SAEs will be reported in the adverse events module.
Time frame: Baseline through final follow-up at approximately Day 155
Area Under the Concentration Versus Time Curve During a Dosing Interval (AUC0-tau) at Steady State
Pharmacokinetics (PK) after single and multiple IV dosing.
Time frame: Day 1 (End of the infusion [EOI]) up to Day 155 post EOI
Half-Life (t1/2)
PK after single and multiple IV dosing.
Time frame: Day 1 (EOI) up to Day 155 post EOI
Concentrations at End of Infusion (Cmax)
PK after single and multiple IV dosing.
Time frame: Day 1 (EOI) up to Day 155 post EOI
Concentrations at End of Dosing Interval (Ctrough)
PK after single and multiple IV dosing.
Time frame: Day 1 (EOI) up to Day 155 post EOI
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.