Phase 1
Completed N=56
Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults
Healthy Volunteer
Source: ClinicalTrials.gov NCT02151110 ↗
Enrolled (actual)
56
Serious AEs
1.8%
Results posted
Feb 2019
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) — 10; 1; 1; 5 Participants
Summary
Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
10; 1; 1; 5; 8; 3 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of MEDI4920 |
1.00; 4.46; 7.97; 23.6; 85.6; 289 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI4920 |
3.64; 19.3; 53.4; 151; 581; 2090 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI4920 |
4.60; 20.5; 54.8; 152; 583; 2090 | — |
| SECONDARY Dose-normalized AUC0-inf (AUC0-infinity/D) of MEDI4920 |
1.53; 2.05; 1.83; 1.52; 1.94; 2.09 | — |
| SECONDARY Terminal Elimination Half Life (t1/2) of MEDI4920 |
4.41; 5.35; 5.31; 5.49; 8.86; 9.68 | — |
| SECONDARY Systemic Clearance (CL) of MEDI4920 |
661; 487; 564; 668; 517; 494 | — |
| SECONDARY Volume of Distribution at Steady-state (Vss) of MEDI4920 |
3980; 3290; 4280; 5560; 5180; 5450 | — |
| SECONDARY Volume of Distribution Based on Terminal Phase (Vz) of MEDI4920 |
4130; 3760; 4080; 5230; 6590; 6880 | — |
| SECONDARY Percentage of Participants Positive for Anti-drug Antibodies (ADA) |
16.7; 0; 0; 0; 0; 0 | — |
| SECONDARY T-cell Dependent Antibody Response (TDAR) Measured by Anti-keyhole Limpet Hemocyanin Immunoglobulin G (Anti-KLH IgG) Concentration |
NA; 0.99; 0.96; 0.88; 0.68; 0.42 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy as determined by a responsible study physician based on medical evaluation
- Body weight 40 to 100 kg
- Body mass index 19.0 to 30.0 kg/m2
Exclusion Criteria
- History of allergy or sensitivity to Shellfish or protein based antigens
- previous immunization with KLH
- previous splenectomy
- History of diagnosed or suspected thromboembolic event or coagulation disorder
Data sourced from ClinicalTrials.gov (NCT02151110). 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.