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

MedImmune

Status and phase: Completed; Phase 1

Conditions: Healthy Adults

Treatments: Drug: Placebo SC; Biological: MEDI7836 Dose 2; Biological: MEDI7836 Dose 4; Biological: MEDI7836 Dose 3; Biological: MEDI7836 Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02388347

D5450C00001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 79 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo SC

MEDI7836 Dose 1

Experimental group

Description:

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

Treatment:

Biological: MEDI7836 Dose 1

MEDI7836 Dose 2

Experimental group

Description:

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

Treatment:

Biological: MEDI7836 Dose 2

MEDI7836 Dose 3

Experimental group

Description:

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

Treatment:

Biological: MEDI7836 Dose 3

MEDI7836 Dose 4

Experimental group

Description:

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

Treatment:

Biological: MEDI7836 Dose 4