Influenza infection Infections and Infestations
Conditions
Interventions
Participants identification codes will be assigned at screening. All participants will receive open-label CD388 450mg. Participants will receive investigational study intervention as 3 separate inject
Sponsors
hVIVO Limited Services
Eligibility
Sex/Gender
All
Age
18 Years to 66 Years
Inclusion criteria
Inclusion criteria: 1. Be willing and able to provide written informed consent and comply with scheduled visits, laboratory tests, and other study procedures. 2. Be a male or female adult aged 18 to 66 years of age who previously completed participation in Study CD388.SQ.2.05, having received a SQ CD388 dose of either 150 mg, 300 mg or 450 mg. (Note: Participants in this study may have received seasonal influenza vaccine prior to enrolment in this study and may receive influenza vaccine during this study, with certain exceptions) 3. Be in stable health at the time of screening and enrollment (in the Investigator’s clinical judgment). Participants may not have a history of underlying hematologic, oncologic, renal, autoimmune, cardiac, or pulmonary conditions; or be considered at risk of developing complications from influenza infection per the CDC guidelines (chronic obstructive pulmonary disease [COPD], asthma, current immune-compromised cancer [except non-melanomatous skin cancer], or diabetes). Study participants will be included based on medical history and vital signs obtained during the screening process. 4. Have a body mass index (BMI) of = 18.0 kg/m². 5. Must agree to the contraception requirements. 6. Must agree not to donate blood from Day 1 until 40 weeks after each administration of CD388. 7. Must be able to read, understand, and complete protocol questionnaires using the Sponsor-designated diary mode (eDiary or paper) and language, and be willing and able to adhere to the prohibitions and restrictions specified in this protocol. If eDiary is designated, the participant must be able to use a smartphone/tablet/computer. If an appropriate language version is not available in either eDiary or paper, the participant must not be enrolled. The diary mode and approved languages will be designated by the Sponsor prior to study start. 8. Must be willing to provide verifiable identification, has means to be contacted, and is able to contact the Investigator/study site and communicate reliably during participation in this study.
Exclusion criteria
Exclusion criteria: 1. Have a known or suspected allergy or history of anaphylaxis or other SAEs to zanamivir (following administration of inhaled or intravenous formulations), monoclonal antibodies (including Fc domains), or any of the components of CD388. 2. Have an acute illness (including acute respiratory illnesses) or body temperature = 38.0 °C (= 100.4 °F) within 7 days prior to each administration of CD388. (Note: Enrollment and/or receipt of study intervention at a later date, subsequent to resolution of the illness [within the screening period], is permitted.) 3. Have a serious and/or clinically unstable condition, including but not limited to, a psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, Alzheimer’s disease, or any other condition which in the opinion of the Investigator might lead to hospitalization or death within this study period and for which enrollment would not be in the participant’s best interest, or could prevent, confound, or limit the protocol-specified assessments. 4. Have any history of alcohol or substance abuse which in the opinion of the investigator might interfere with conduct of this study as planned. 5. Had major surgery (eg, cardiac, pulmonary, neurologic, or abdominal operations) within 4 weeks prior to screening, or will not have fully recovered from such prior surgery; or has major surgery planned during the time the participant is expected to participate in this study. 6. Had screening electrocardiogram (ECG) findings of prolonged QTcF interval (> 450 msec in males or > 470 msec in females), prolonged PR interval (> 220 msec), second- or third-degree heart block, or other clinically significant dysrhythmia. 7. Have any finding (at the time of screening) that may significantly increase the risk of participation in this study, affect the ability to participate in this study, or impair interpretation of the study data. 8. Have current or planned participation in another clinical study where study intervention is being administered while participating in this current study. Note: Concurrent enrollment is allowed during the follow-up phase of the other clinical study or in case the study intervention in the other clinical study is a marketed product already approved for another indication – exception being if the other study requires study interventions that could affect the safety assessments of this present study (eg, clinical laboratory tests). 9. Have received any experimental drug, vaccine, or biologic agent within the past 90 days or 5 half-lives (whichever is longer) prior to study intervention administration. 10. Have a contraindication to SQ injections and venipunctures (eg, bleeding disorders). 11. Have donated = 450 mL of blood product (1 unit) for any reason within 30 days of screening or have plans to donate blood product during this study. 12. Are currently pregnant or breastfeeding, intends to become pregnant or breastfeed, or has a positive pregnancy test during the screening period. 13. Has direct involvement in this proposed study or other studies under the direction of the Investigator, sub-investigators, or study site personnel; is a family member of an individual with such direct involvement; or is an employee of the Sponsor. 14. Did not complete participation in protocol CD388.SQ.2.05, or experienced an SAE during that study, or was enrolled in CD388.SQ.2.05 despite not meeting that study’s eligibility (one or more Inclusion Criteria not met or on
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood sample assessment will be taken via venepuncture at predose and 4,12,24 and 28 weeks following each annual dose to evaluate the treatment – emergent ADA and treatment-boosted ADA | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability, as assessed by adverse events (AEs), injection site reactions (ISRs), vital signs, and clinical laboratory parameters. 2. Plasma PK parameters of CD388 (eg, plasma concentrations at pre-dose, 8 days, and 4, 12, 24, and 28 weeks following each annual dose; trough plasma concentration at 24 weeks [Ctrough24w], maximum plasma concentration [Cmax], and area under the plasma concentration-time curve [AUC]) 3. Plasma concentration-time data or PK parameter of CD388 and titer of anti-CD388 antibody, when present | — |
Countries
United Kingdom
Contacts
Public ContactSumreen Aftab
Outcome results
None listed