The goal of this clinical study is to learn if giving repeated annual doses of the experimental drug CD388 is safe and how the body reacts to it in healthy adults who have already received one dose without serious side effects. The study aims to determine if the body makes antibodies against CD388 after repeated doses, which might affect how the drug works or how safe it is, and to better understand the safety and tolerability of repeated doses. Participants will receive two doses of CD388 over two years and be monitored for 18 months. Researchers will check for immune responses against the drug, watch for any side effects, and measure how the drug behaves in the body over time. This study is based on the idea that people who tolerated CD388 well before will likely continue to tolerate it safely with repeated annual dosing, and that the risk of immune reactions will remain low. Expanded access to the study drug will not be provided to participants after the study ends.
This is a Phase 2, open-label, long-term study to evaluate the occurrence of anti-drug antibodies (ADAs) directed to CD388 during an 18-month period following administration of 2 annual doses of CD388 in healthy participants who previously completed study CD388.SQ.2.05, having received a dose of the active drug without experiencing any serious adverse event(s) (SAE\[s\]) during that study. This study will also evaluate the safety and tolerability of CD388 and the pharmacokinetics (PK) of CD388 following repeated annual dosing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
400
CD388 liquid for injection
Floridian Clinical Research
Miami Lakes, Florida, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
hVIVO Serviced Limited
London, England, United Kingdom
Occurrence of Anti-Drug Antibodies (ADAs) in Participants Administered CD388
Evaluation of blood serum samples for the occurrence of treatment-emergent anti-drug antibodies (ADAs) or treatment-boosted ADAs (based on an increase in ADA titer in samples positive for ADA at baseline) directed to CD388 in participants following administration of each annual dose of CD388.
Time frame: On Day 1 (pre-dose baseline), Day 29, Day 85, Day 169, and Day 197 in Study Period 1; on Day 1 (pre-dose), Day 29, Day 85, Day 169, and Day 197/End of Study (EOS) in Study Period 2
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) after Administration of Study Drug
Safety and tolerability of CD388 will be evaluated by assessing the number of participants with incidences of TEAEs following the administration of study drug. TEAEs include but are not limited to adverse events (AEs), serious adverse events (SAEs), injection site reactions (ISRs), and any potentially clinically significant changes from baseline seen in vital signs and clinical laboratory parameters.
Time frame: From Study Period 1 Day 1 after study drug dosing through Study Period 2 Day 197/EOS
Plasma Concentrations at Specified Timepoints Following Administration of CD388
Evaluation of the plasma concentration of CD388 at specified timepoints after study drug dosing.
Time frame: In both Study Periods 1 and 2 on Day 1 (pre-dose), Day 8, Day 29, Day 85, Day 169, and Day 197/EOS as applicable
Trough Plasma Concentration at 24 Weeks (C[trough24w]) Following Administration of CD388
Evaluation of the trough plasma concentration at 24 weeks (C\[trough24w\]) after study drug dosing.
Time frame: In both Study Periods 1 and 2 on Day 169
Maximum Plasma Concentration (C[max]) Following Administration of CD388
Evaluation of the maximum plasma concentration (C\[max\]) after study drug dosing.
Time frame: In both Study Periods 1 and 2 on Day 1 (pre-dose), Day 8, Day 29, Day 85, Day 169, and Day 197/EOS as applicable
Area Under the Plasma Concentration-Time Curve (AUC) Following Administration of CD388
Evaluation of the area under the plasma concentration-time curve (AUC) after study drug dosing.
Time frame: In both Study Periods 1 and 2 on Day 1 (pre-dose), Day 8, Day 29, Day 85, Day 169, and Day 197/EOS as applicable
Correlation of Plasma Concentration of CD388 and Titer of Anti-CD388 Antibodies at Time Points Where ADAs are Present
Comparison of the plasma concentration of CD388 to the titer of CD388 ADAs at time points where ADAs are present in participants administered CD388.
Time frame: In both Study Periods 1 and 2 on Day 1 (pre-dose), Day 29, Day 85, Day 169, and Day 197/EOS as applicable
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.