A Phase 1 interventional study of SRK-001 and Placebo in Healthy Participants, sponsored by Sarkana Pharma Inc. Terminated at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-13.
Sponsored by Sarkana Pharma Inc · Phase 1, Interventional, and Treatment
The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of SRK-001 in Healthy Participants.
This is the only study on the registry with Sarkana Pharma Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Healthy male participants
Healthy female participants of childbearing potential who have a fertile male sexual partner must be willing and able to practice effective contraception from screening to 90 days after the last dose of the study intervention. Sexually active participants must use a combination of 2 of the following methods of contraception, including at least 1 so-called 'barrier' method:
Exclusion Criteria:
Participants will receive intravenous (IV) SRK-001 every 2 weeks (Q2W) for 4 doses.
Drug: SRK-001
Participants will receive IV SRK-001 every 4 weeks (Q4W) for 2 doses.
Drug: SRK-001
Participants will receive IV SRK-001 Q2W for 4 doses.
Drug: SRK-001
Participants will receive IV placebo Q2W for 4 doses or Q4W for 2 doses.
Drug: Placebo
Participants will receive IV doses of SRK-001.
Participants will receive IV doses of placebo.
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 study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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