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

NCT ID: NCT02388347

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-04-30

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.

Detailed Description

This is a Phase 1a, randomised, blinded (the investigator and subject will be blinded to treatment assignment and sponsor will be unblinded to treatment assignment), placebo-controlled study to evaluate the safety of single-ascending SC doses of MEDI7836 in healthy adult males subjects and healthy adult female subjects of non-childbearing potential. The study will be conducted at a single site in the United Kingdom (UK). Four dosing cohorts of MEDI7836 or placebo are planned for this study for a total of 32 subjects (24 subjects receiving MEDI7836, 8 subjects receiving placebo).

Conditions

Healthy Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo SC

Intervention Type: DRUG

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

MEDI7836 Dose 1

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

Group Type: EXPERIMENTAL

MEDI7836 Dose 1

Intervention Type: BIOLOGICAL

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

MEDI7836 Dose 2

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

Group Type: EXPERIMENTAL

MEDI7836 Dose 2

Intervention Type: BIOLOGICAL

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

MEDI7836 Dose 3

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

Group Type: EXPERIMENTAL

MEDI7836 Dose 3

Intervention Type: BIOLOGICAL

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

MEDI7836 Dose 4

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

Group Type: EXPERIMENTAL

MEDI7836 Dose 4

Intervention Type: BIOLOGICAL

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

Interventions

Placebo SC

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

Intervention Type: DRUG

MEDI7836 Dose 1

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

Intervention Type: BIOLOGICAL

MEDI7836 Dose 2

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

Intervention Type: BIOLOGICAL

MEDI7836 Dose 3

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

Intervention Type: BIOLOGICAL

MEDI7836 Dose 4

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Vital signs, ECG, and laboratory parameters within normal range at screening and Day -1

2. Negative alcohol and drug screen at screening and Day -1

3. Able and willing to comply with the requirements of the protocol

4. Females subjects must have been surgically sterilised or be postmenopausal

5. 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

Exclusion Criteria

1. Concurrent enrolment in another clinical study where the subject is receiving an investigational product

2. Individuals who are legally institutionalised

3. Receipt of any marketed or investigational biologic agent within 4 months

4. Receipt of any investigational non-biologic agent within 3 months or 5 half-lives prior to screening, whichever is longer

5. Use of any medication (prescription or over the counter, including herbal remedies) within 14 days or 5 half-lives of Day 1,

6. Known history of allergy or reaction to any component of the investigational product formulation

7. History of anaphylaxis following any biologic therapy

8. History of chronic alcohol or drug abuse within 12 months prior to screening,

9. Presence of a positive drug or alcohol screen at screening and Day -1.

10. Current smoker, or history of smoking within 6 months of screening

11. Pregnant or breastfeeding women

12. 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

13. Any clinically relevant abnormal findings in physical examination, ECG, vital signs, haematology, clinical chemistry or urinalysis during screening or Day -1,

14. History of any known primary immunodeficiency disorder or use of immunosuppressive medication within 12 months of screening

15. History of a clinically significant infection requiring antibiotics or antiviral medication from 30 days prior to screening, up to and including Day 1

16. Diagnosis of a helminth parasitic infection within 6 months prior to screening that has not been treated with, or has failed to respond to, standard of care therapy

17. History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 12 months prior to screening or other malignancies treated with apparent success with curative therapy ≥ 5 years prior to screening

18. Positive tuberculosis (TB) test (Quantiferon-TB Gold) at screening or TB requiring treatment within the 12 months prior to the screening visit

19. Positive hepatitis B surface antigen, hepatitis B anti-core antibody, or hepatitis C virus antibody serology at screening.

20. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enter the study.

21. A positive human immunodeficiency virus test at screening or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report

22. Evidence of active liver disease, including jaundice or aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase greater than twice the upper limit of normal (ULN)

23. Major surgery within 8 weeks prior to screening, or planed in-patient surgery or hospitalisation during the study period

24. Receipt of live attenuated vaccines 30 days prior to the date of screening Where participation in the study would result in donation of blood or blood products in excess of 500 mL within an 8-week period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annelize Koch, MD

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

Research Site

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

D5450C00001

Identifier Type: -

Identifier Source: org_study_id