Phase 1
Completed N=89
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
Source: ClinicalTrials.gov NCT02290340 ↗Enrolled (actual)
89
Serious AEs
3.4%
Results posted
Sep 2018
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) — 17; 5; 31; 30 Participants
Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm infants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
17; 5; 31; 30; 0; 0 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events of Special Interest |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events |
6; 0; 8; 4; 0; 0 | — |
| SECONDARY Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 |
7.04; 7.04; 6.93 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of MEDI8897 |
23.2; 30.9; 71.7 | — |
| SECONDARY Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897 |
1940; 2260; 5470 | — |
| SECONDARY Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897 |
2450; 4320; 7510 | — |
| SECONDARY Terminal Elimination Half Life (t1/2) of MEDI8897 |
72.9; 66.2; 62.5 | — |
| SECONDARY Extravascular Clearance (CL/F) of MEDI8897 |
4.08; 6.05; 7.01 | — |
| SECONDARY Extravascular Volume of Distribution (Vz/F) of MEDI8897 |
429; 581; 633 | — |
| SECONDARY Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 |
1; 0; 0; 0; 0; 2 | — |
Eligibility Criteria
Key Inclusion Criteria
- Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age
- Infants who are entering their first RSV season at the time of screening
Key Exclusion Criteria
- Gestational age 34 weeks 6 days
- Meets AAP or other local criteria to receive commercial palivizumab
- Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization
- Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
- Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
- Receipt of palivizumab or any RSV vaccine, including maternal RSV vaccination
Data sourced from ClinicalTrials.gov (NCT02290340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.