NCT02388347

A Phase 1a, Randomised, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI7836 in Healthy Adults

Completed Phase 1 Results posted Last updated 13 April 2017

What this trial tests

Phase 1 trial testing Placebo SC in Healthy Adults in 79 participants. Completed in 1 April 2016.

Timeline

1 March 2015

Primary endpoint
1 January 2016

1 April 2016

Quick facts

Lead sponsor	MedImmune LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	79
Start date	1 March 2015
Primary completion	1 January 2016
Estimated completion	1 April 2016
Sites	1 location across United Kingdom

Drugs / interventions tested

• Placebo SC — full drug profile →
• MEDI7836 Dose 1 — full drug profile →
• MEDI7836 Dose 2
• MEDI7836 Dose 3
• MEDI7836 Dose 4

Conditions studied

• Healthy Adults — all drugs for Healthy Adults →

Sponsor

MedImmune LLC — full company profile →

Who can join

Adults 18 to 50, any sex, with Healthy Adults. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
  Time frame: From Study Drug Administration to 281 Days Postdose
  Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization;
• Number of Participants With Injection Site Reactions
  Time frame: From Study Drug Administration to 281 Days Postdose
  Participants were evaluated for manifestations of injection site reactions.
• Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
  Time frame: From Study Drug Administration to 281 Days Postdose
  An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between first dose of study drug and Day 281 after the last dose that were absent before treatment or that worsened relative
• Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment-Emergent Adverse Events
  Time frame: From Study Drug Administration to 281 Days Postdose
  Vital sign parameters included blood pressure, temperature, pulse rate, respiratory rate and weight. Physical examination included assessment of general appearance, weight, head, ears, eyes, nose, throat, neck, skin, cardiovascular system, respiratory system, abdominal system, and nervous system. Criteria for abnormal physical findings was based on investigator's discretion. TEAEs were present at
• Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events
  Time frame: From Study Drug Administration to 281 Days Postdose
  AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS, QT and QTc intervals. Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pre-treatment state.

Sponsor's own description

To assess the safety of a single ascending dose of MEDI7836 in healthy adult male subjects and healthy adult female subjects of non-childbearing potential.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmacokinetic-Pharmacodynamic Modelling of Systemic IL13 Blockade by Monoclonal Antibody Therapy: A Free Assay Disguised as Total.
   Hood J, González-García I, White N, Marshall L, et al · · 2021 · cited 4× · PMID 33918602 · DOI 10.3390/pharmaceutics13040519