Phase 1
Completed N=136
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
Source: ClinicalTrials.gov NCT02114268 ↗Enrolled (actual)
136
Serious AEs
1.5%
Results posted
Nov 2016
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) — 21; 3; 3; 5 participants
Summary
The purpose of this study was 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 adult participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
21; 3; 3; 5; 4; 48 | — |
| SECONDARY Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 |
0.078; 0.059; 0.209; 5.46; 9.42 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) for MEDI8897 |
96.98; 333.80; 1163.32; 20.40; 47.48 | — |
| SECONDARY Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897 |
6714.75; 25320.68; 63580.33; 2249.11; 5193.73 | — |
| SECONDARY Terminal Phase Elimination Half Life (t1/2) for MEDI8897 |
116.52; 92.0; 89.81; 102.61; 85.29 | — |
| SECONDARY Systemic Clearance (CL) for MEDI8897 |
46.05; 40.33; 47.60; 45.46; 64.60 | — |
| SECONDARY Volume of Distribution (Vz) for MEDI8897 |
7694.15; 5426.89; 6137.69; 6808.78; 7455.90 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibody (ADA) |
3; 0; 0; 0; 0; 5 | — |
Eligibility Criteria
Key Inclusion Criteria
- Age 18 through 49 years and in good health by history, physical exam, and labs
- Weight greater than or equal to (>=) 45 kilogram (kg) and less than or equal to ( = 99.5 Fahrenheit (°F) on day of dosing
- Any drug therapy within 7 days prior to Day 1 (except contraceptives)
- Receipt of any investigational drug therapy within 120 days prior to investigational product dosing through 360 days after investigational product dosing
- Previous receipt of a monoclonal antibody (mAb)
- Pregnant or nursing mother
- Concurrent enrollment in another interventional study
Data sourced from ClinicalTrials.gov (NCT02114268). 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.