Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects

MedImmune

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects; Safety

Treatments: Drug: MEDI9314; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02669667

D4361C00002

Details and patient eligibility

About

This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to assess the safety and tolerability of MEDI9314 in healthy adult subjects

Full description

This is a phase I study to assess the safety, tolerability pharmacokinetics, and immunogenicity of MEDI9314 following single dose administration to healthy subjects

Enrollment: 44 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Written informed consent.
2. Age 18 through 50 years at the time of screening.
3. Female subjects must be of non-childbearing potential.
4. Nonsterilized males who are sexually active with a female partner of childbearing potential must use condom and spermicide.
5. Body mass index of 19.0 through 32.0 kg/m2 at screening.
6. No clinically significant abnormality on the basis of medical/medication history or physical examination.
7. Negative drugs of abuse (DOA).
8. Able and willing to comply with the requirements of the protocol and complete the study until the end of the safety follow up period.
9. For the Japanese Cohort, both of the subject's parents and both sets of grandparents must be Japanese.

Exclusion criteria

1. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
2. Concurrent enrollment in another clinical study involving any treatment.
3. Individuals who are legally institutionalized.
4. Receipt of > 2 marketed or investigational biologic agents.
5. Receipt of an investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer.
6. Receipt of any investigational non biologic agent within 3 months or 5 half lives prior to screening, whichever is longer.
7. Use of any medication (prescription or over the counter, including herbal remedies) within 14 days or 5 half lives of Day 1, whichever is longer, unless in the opinion of the investigator and medical monitor the medication will not interfere with the study procedures or compromise subject safety.
8. Known history of allergy or reaction to any component of the investigational product formulation.
9. History of anaphylaxis following any biologic therapy.
10. Any clinically relevant abnormal findings in physical examination ECG, vital signs, and laboratory parameters.
11. Positive tuberculosis (TB) test (QuantiFERON®-TB Gold In-tube).
12. Positive hepatitis B surface antigen, hepatitis C virus antibody or HIV test at screening.
13. Receipt of live attenuated vaccines 30 days prior to the date of screening.
14. Where donation of blood or blood products was in excess of 500 mL within an 8-week period in the 3 months prior to screening.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 6 patient groups

Cohort 1

Experimental group

Description:

single dose of MEDI9314 or placebo

Treatment:

Drug: placebo

Drug: MEDI9314

Cohort 2

Experimental group

Description:

single dose of MEDI9314 or placebo

Treatment:

Drug: placebo

Drug: MEDI9314

Cohort 3

Experimental group

Description:

single dose of MEDI9314 or placebo

Treatment:

Drug: placebo

Drug: MEDI9314

Cohort 4

Experimental group

Description:

single dose of MEDI9314 or placebo

Treatment:

Drug: placebo

Drug: MEDI9314

Japanese Cohort

Experimental group

Description:

single dose of MEDI9314 or placebo

Treatment:

Drug: placebo

Drug: MEDI9314

Cohort 5

Experimental group

Description:

single dose of MEDI9314 or placebo

Treatment:

Drug: placebo

Drug: MEDI9314