CompletedPhase 1

Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults

United Kingdom59 participantsStarted 2014-05-27

Plain-language summary

Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920

Who can participate

Age range18 Years – 49 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Timeframe: The start of study drug administration (Day 1) to the follow-up period (Day 113) or early discontinuation visit

Trial details

NCT IDNCT02151110

SponsorMedImmune LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-05-09

Results submitted2017-05-24

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