A Study to Assess the Safety of MEDI7836 in Healthy Adults.

NCT02388347 | Completed Phase 1 Results

• 1 other identifier: D5450C00001
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (5)

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

  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; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received MEDI7836. Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pretreatment state.

  From Study Drug Administration to 281 Days Postdose

• Number of Participants With Injection Site Reactions

  Participants were evaluated for manifestations of injection site reactions.

  From Study Drug Administration to 281 Days Postdose

• Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events

  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 to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.

  From Study Drug Administration to 281 Days Postdose

• Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment-Emergent Adverse Events

  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 baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Day 281 after the last dose of study drug.

  From Study Drug Administration to 281 Days Postdose

• Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events

  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.

  From Study Drug Administration to 281 Days Postdose

Secondary Outcomes (8)

• Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI7836

  Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose

• Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t]) of MEDI7836

  Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose

• Maximum Observed Serum Concentration (Cmax) of MEDI7836

  Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose

• Apparent Systemic Clearance (CL/F) of MEDI7836

  Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose

• Terminal Phase Elimination Half Life (T1/2) of MEDI7836

  Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1.

Drug: Placebo SC

MEDI7836 Dose 1

EXPERIMENTAL

Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1.

Biological: MEDI7836 Dose 1

MEDI7836 Dose 2

EXPERIMENTAL

Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1.

Biological: MEDI7836 Dose 2

MEDI7836 Dose 3

EXPERIMENTAL

Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1.

Biological: MEDI7836 Dose 3

MEDI7836 Dose 4

EXPERIMENTAL

Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.

Biological: MEDI7836 Dose 4

Interventions

Placebo SC DRUG

Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1.

Placebo

MEDI7836 Dose 1 BIOLOGICAL

Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1.

MEDI7836 Dose 1

MEDI7836 Dose 2 BIOLOGICAL

Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1.

MEDI7836 Dose 2

MEDI7836 Dose 3 BIOLOGICAL

Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1.

MEDI7836 Dose 3

MEDI7836 Dose 4 BIOLOGICAL

Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.

MEDI7836 Dose 4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Vital signs, ECG, and laboratory parameters within normal range at screening and Day -1
• Negative alcohol and drug screen at screening and Day -1
• Able and willing to comply with the requirements of the protocol
• Females subjects must have been surgically sterilised or be postmenopausal
• Nonsterilised males who are sexually active with a female partner of childbearing potential or a female partner who has been surgically sterilised by bilateral tubal ligation must use a condom with spermicide with their partner from screening until the end of the study follow-up period

You may not qualify if:

• Concurrent enrolment in another clinical study where the subject is receiving an investigational product
• Individuals who are legally institutionalised
• Receipt of any marketed or investigational biologic agent within 4 months
• Receipt of any investigational non-biologic agent within 3 months or 5 half-lives prior to screening, whichever is longer
• Use of any medication (prescription or over the counter, including herbal remedies) within 14 days or 5 half-lives of Day 1,
• Known history of allergy or reaction to any component of the investigational product formulation
• History of anaphylaxis following any biologic therapy
• History of chronic alcohol or drug abuse within 12 months prior to screening,
• Presence of a positive drug or alcohol screen at screening and Day -1.
• Current smoker, or history of smoking within 6 months of screening
• Pregnant or breastfeeding women
• Any active medical or psychiatric condition or other reason which, in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject's ability to participate in the study
• Any clinically relevant abnormal findings in physical examination, ECG, vital signs, haematology, clinical chemistry or urinalysis during screening or Day -1,
• History of any known primary immunodeficiency disorder or use of immunosuppressive medication within 12 months of screening
• History of a clinically significant infection requiring antibiotics or antiviral medication from 30 days prior to screening, up to and including Day 1

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

Results Point of Contact

• Title: Rene van der Merwe
• Organization: MedImmune LLC

information.center@astrazeneca.com

Study Officials

• Annelize Koch, MD

  Parexel

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 17, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 16, 2017
• Results First Posted: April 12, 2017

Record last verified: 2017-04

Locations

GB (1)