This phase 1 study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of DISC-3405 in adult male and female healthy volunteers.
Each enrolled subject will receive one single or multiple doses of DISC-3405 or placebo. During the study, subjects will be evaluated for safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of DISC-3405. In the single ascending dose (SAD) phase, a sentinel group of two subjects will be dosed first: one with DISC-3405, and the other with placebo; the randomization and blinding will be maintained. The remaining subjects for the cohort will be dosed at least 24 hours after the last sentinel dosing following approval from the principal investigator. Subsequent multiple ascending dose (MAD) cohorts will only enroll after a sufficient safety observation period for the SAD cohort, accordingly there will be no sentinel participants for cohorts in MAD. DISC-3405 or placebo will be administered as an IV infusion or subcutaneous injection. Subjects will have end-of-study (EOS) follow-up visits on Day 99 after the last administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Celerion
Lincoln, Nebraska, United States
Incidence of adverse events
Time frame: up to 99 days
Incidence of treatment-emergent clinically abnormal physical exam
Time frame: up to 99 days
Incidence of treatment-emergent clinically significant laboratory test results
Time frame: up to 99 days
Incidence of treatment-emergent clinically significant electrocardiograms (ECGs)
Time frame: up to 99 days
Incidence of treatment-emergent clinically abnormal vital signs
Time frame: up to 99 days
Plasma maximum measured drug concentration (Cmax)
Time frame: up to 99 days
Time of maximum concentration (Tmax)
Time frame: up to 99 days
Area under the concentration-time curve from dosing to the last measurable time point (AUC0-t)
Time frame: up to 99 days
Area under the concentration-time curve from dosing to infinity (AUC0-∞)
Time frame: up to 99 days
Drug elimination half-life (T½ el)
Time frame: up to 99 days
Volume of plasma cleared (CL)
Time frame: up to 99 days
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Placebo is administered in multiple ascending doses as an IV infusion or subcutaneous injection
Trough Concentration (Ctrough)
Time frame: up to 99 days
Volume of Distribution (Vd)
Time frame: up to 99 days
Elimination rate constant (Kel)
Time frame: up to 99 days
Change from baseline of hepcidin levels
Time frame: up to 99 days
Change from baseline in transferrin saturation (TSAT) levels
Time frame: up to 99 days
Change from baseline of serum iron levels
Time frame: up to 99 days