Safety and tolerability of MEDI9314 as single ascending dose in healthy subjects

Study identifier:D4361C00002

ClinicalTrials.gov identifier:NCT02669667

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1a Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI9314 in Healthy Adult Subjects

Medical condition

Safety, Healthy subjects

Phase

Phase 1

Healthy volunteers

Yes

Study drug

MEDI9314, placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 18 Feb 2016

Primary Completion Date: 17 Nov 2016

Study Completion Date: 12 Jun 2017

Study design

Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 May 2019 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

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.

No locations available

Arms	Assigned Interventions
Experimental: Cohort 1 single dose of MEDI9314 or placebo	Drug: MEDI9314 single dose of MEDI9314 Drug: placebo single dose of placebo
Experimental: Cohort 2 single dose of MEDI9314 or placebo	Drug: MEDI9314 single dose of MEDI9314 Drug: placebo single dose of placebo
Experimental: Cohort 3 single dose of MEDI9314 or placebo	Drug: MEDI9314 single dose of MEDI9314 Drug: placebo single dose of placebo
Experimental: Cohort 4 single dose of MEDI9314 or placebo	Drug: MEDI9314 single dose of MEDI9314 Drug: placebo single dose of placebo
Experimental: Japanese Cohort single dose of MEDI9314 or placebo	Drug: MEDI9314 single dose of MEDI9314 Drug: placebo single dose of placebo
Experimental: Cohort 5 single dose of MEDI9314 or placebo	Drug: MEDI9314 single dose of MEDI9314 Drug: placebo single dose of placebo

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Muna Albayaty

PAREXEL