The purpose of this study is to evaluate the effectiveness of CD388 in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, and to select a dose of CD388 that is effective in preventing the same, when administered as a single dose via 3 subcutaneous (SQ) injections to adult participants in stable health, and to evaluate the safety and tolerability of CD388, as compared to placebo.
This is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter dose selection study to evaluate the efficacy, safety, and tolerability of 3 dose levels of CD388 administered as a single dose via 3 SQ injections in adult participants who are not at risk of developing complications from influenza.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
5,071
CD388 liquid for injection
Placebo to match
Percentage of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug
Percentage of participants experiencing protocol-defined ILI occurring after administration of CD388, with central laboratory-confirmed reverse-transcriptase polymerase chain reaction positive (RT-PCR+) influenza infection based on the nasopharyngeal (NP) swab result, as compared to placebo.
Time frame: From Day 8 up to 24 weeks after study drug dosing
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) after Administration of Study Drug
Safety and tolerability of CD388, as compared to placebo, 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, 12-lead electrocardiograms (ECGs), and clinical laboratory parameters.
Time frame: From Day 1 through Day 197/End of Study (EOS) after study drug dosing
Percentage of Participants Experiencing Protocol-defined ILI Occurring ≥7 Days after and up to 28 Weeks after Administration of Study Drug
Percentage of participants experiencing protocol-defined ILI occurring after administration of CD388, with central laboratory-confirmed RT-PCR+ influenza infection based on the NP swab result, as compared to placebo.
Time frame: From Day 8 up to 28 weeks after study drug dosing
Percentage of Participants Experiencing Protocol-defined ILI (as in Primary Endpoint 1) Except with a Lower Threshold for New Onset of Fever
Percentage of participants experiencing protocol-defined ILI occurring after administration of CD388, with central laboratory-confirmed RT-PCR+ influenza infection based on the NP swab result, as compared to placebo. New onset of fever is defined as oral temperature ≥37.2 degrees Celsius (°C). Respiratory symptoms are influenza-associated and as described in the protocol. Onset events include those occurring ≥7 days after and up to 24 weeks following study drug administration.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Cullman Clinical Trials
Cullman, Alabama, United States
Fiel Family and Sports Medicine/CCT Research
Tempe, Arizona, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Velocity Clinical Research - Huntington Park
Huntington Park, California, United States
Velocity Clinical Research - San Diego
La Mesa, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Profound Research LLC
Oceanside, California, United States
Acclaim Clinical Research
San Diego, California, United States
...and 47 more locations
Time frame: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing Protocol-defined ILI (as in Primary Endpoint 1) Except the Influenza Infection is Based on the Midturbinate (MT) Swab Result
Percentage of participants experiencing protocol-defined ILI occurring after administration of CD388, with the influenza infection based on the MT swab result, as compared to placebo.
Time frame: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection AND New Onset of Fever AND New Onset of ≥2 Respiratory Symptoms after Administration of Study Drug
Percentage of participants experiencing a central laboratory-confirmed RT-PCR+ influenza infection based on the NP swab result (first occurrence only) occurring after administration of CD388, as compared to placebo. New onset of fever is defined as oral temperature ≥37.8°C. Respiratory symptoms are influenza-associated and as described in the protocol. Onset events include those occurring ≥7 days after and up to 24 weeks following study drug administration.
Time frame: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection AND New Onset of ≥2 Respiratory Symptoms after Administration of Study Drug
Percentage of participants experiencing a central laboratory-confirmed RT-PCR+ influenza infection based on the NP swab result (first occurrence only) occurring after administration of CD388, as compared to placebo. Respiratory symptoms are influenza-associated and as described in the protocol. Onset events include those occurring ≥7 days after and up to 24 weeks following study drug administration.
Time frame: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection AND New Onset of ≥1 Respiratory Symptom AND New Onset of ≥1 Systemic Symptom after Administration of Study Drug
Percentage of participants experiencing a central laboratory-confirmed RT-PCR+ influenza infection based on the NP swab result (first occurrence only) occurring after administration of CD388, as compared to placebo. Respiratory symptoms are influenza-associated and as described in the protocol. Onset events include those occurring ≥7 days after and up to 24 weeks following study drug administration.
Time frame: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection, AND New Onset of ≥2 Respiratory Symptoms, OR ≥1 Respiratory Symptom AND New Onset of ≥1 Systemic Symptom, after Administration of Study Drug
Percentage of participants experiencing a central laboratory-confirmed RT-PCR+ influenza infection based on the NP swab result (first occurrence only) occurring after administration of CD388, as compared to placebo. Respiratory symptoms are influenza-associated and as described in the protocol. Onset events include those occurring ≥7 days after and up to 24 weeks following study drug administration.
Time frame: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection AND New Onset of Fever, AND New Onset of ≥2 Respiratory Symptoms, OR New Onset of ≥1 Respiratory Symptom Plus New Onset of ≥1 Systemic Symptom, after Administration of Study Drug
Percentage of participants experiencing a central laboratory-confirmed RT-PCR+ influenza infection (first occurrence only) from either the self-collected MT swab (collected prior to the initiation of any antiviral treatment) or the NP swab collected by a health professional, occurring after administration of CD388, as compared to placebo. New onset of fever is defined as oral temperature ≥38°C. Respiratory symptoms are influenza-associated and as described in the protocol. Onset events include those occurring ≥7 days after and up to 24 weeks following study drug administration.
Time frame: From Day 8 up to 24 weeks after study drug dosing
Severity (as Composite Symptom Score) of Participant Reported Influenza-like Symptoms as Based on the Self-reported Responses to the Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) Symptom Scale
Evaluation of the severity (defined as the composite symptom score) of participant reported influenza-like symptoms as based on the self-reported responses to the RiiQ™ Symptom Scale (scored as 0 = none, 1 = mild, 2 = moderate, and 3 = severe) as presented in the participant eDiary. The composite symptom score is defined as the mean of the scores of the non-missing influenza symptoms for each time point. From the time the participant triggers an Acute Respiratory Infection (ARI) Alert in the eDiary until the ARI episode is resolved (defined as 2 consecutive days where all influenza-associated symptoms on the RiiQ™ Symptom Scale have returned to the same severity level as reported at baseline or lower), the participant will complete the RiiQ™ Symptom Scale in the eDiary for a maximum of 29 days, per ARI episode.
Time frame: On Day 1 (pre-dose baseline); and then once daily from the time the participant triggers an ARI Alert in the eDiary until the ARI episode is resolved for a maximum of 29 days per ARI episode, up to 28 weeks after study drug dosing
Severity (as Area Under the Curve [AUC]) of Participant Reported Influenza-like Symptoms as Based on the Self-reported Responses to the RiiQ™ Symptom Scale
Evaluation of the severity (presented as AUC) of participant reported influenza-like symptoms as based on the self-reported responses to the RiiQ™ Symptom Scale (scored as 0 = none, 1 = mild, 2 = moderate, and 3 = severe) as presented in the participant eDiary. AUC will be based on scores of the non-missing influenza symptoms for each time point. From the time the participant triggers an Acute Respiratory Infection (ARI) Alert in the eDiary until the ARI episode is resolved (defined as 2 consecutive days where all influenza-associated symptoms on the RiiQ™ Symptom Scale have returned to the same severity level as reported at baseline or lower), the participant will complete the RiiQ™ Symptom Scale in the eDiary for a maximum of 29 days, per ARI episode.
Time frame: On Day 1 (pre-dose baseline); and then once daily from the time the participant triggers an ARI Alert in the eDiary until the ARI episode is resolved for a maximum of 29 days per ARI episode, up to 28 weeks after study drug dosing
Duration (as Time to Symptom Resolution) of Participant Reported Influenza-like Symptoms as Based on the Self-reported Responses to the RiiQ™ Symptom Scale
Evaluation of the duration (defined as the time from the first report of influenza-associated symptoms to resolution) of participant reported influenza-like symptoms as based on the self-reported responses to the RiiQ™ Symptom Scale (scored as 0 = none, 1 = mild, 2 = moderate, and 3 = severe) as presented in the participant eDiary. From the time the participant triggers an Acute Respiratory Infection (ARI) Alert in the eDiary until the ARI episode is resolved (defined as 2 consecutive days where all influenza-associated symptoms on the RiiQ™ Symptom Scale have returned to the same severity level as reported at baseline or lower), the participant will complete the RiiQ™ Symptom Scale in the eDiary for a maximum of 29 days, per ARI episode.
Time frame: On Day 1 (pre-dose baseline); and then once daily from the time the participant triggers an ARI Alert in the eDiary until the ARI episode is resolved for a maximum of 29 days per ARI episode, up to 28 weeks after study drug dosing
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. PK parameters will be assessed in approximately 120 participants at designated sites only.
Time frame: Based on sampling done at onsite visits on Day 85 (±3 days) and Day 197/EOS (±7 days)
Maximum Plasma Concentration (C[max]) Following Administration of CD388
Evaluation of the maximum plasma concentration (C\[max\]) after study drug dosing. PK parameters will be assessed in approximately 120 participants at designated sites only.
Time frame: At onsite visits done on Day 8, Day 29, and Day 85 (each ±3 days) and on Day 197/EOS (±7 days)
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. PK parameters will be assessed in approximately 120 participants at designated sites only.
Time frame: At onsite visits done on Day 8, Day 29, and Day 85 (each ±3 days) and on Day 197/EOS (±7 days)