Clinical trial NCT02669667: Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety
Healthy Subjects
Keywords: MEDI9314
Safety
Tolerability
Pharmacokinetics
Immunogenicity
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2016-02-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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

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

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: From the start of study drug administration upto Day 240
measure: Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs
timeFrame: From the start of study drug administration upto Day 240
measure: Number of Participants With Vital Signs Abnormalities Reported as TEAEs
timeFrame: From the start of study drug administration upto Day 240
measure: Number of Participants With Physical Examination Abnormalities Reported as TEAEs
timeFrame: From the start of study drug administration upto Day 240
measure: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
timeFrame: From the start of study drug administration upto Day 240
measure: Number of Participants With TEAEs Related to Injection Site Reactions
timeFrame: From the start of study drug administration upto Day 240
Secondary outcomes:
measure: Area Under the Serum Drug Concentration Versus Time Curves From Zero to Infinity (AUC 0-inf) of MEDI9314
timeFrame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
measure: Area Under the Serum Drug Concentration Versus Time Curve, to Last Quantifiable Time Point (AUClast)
timeFrame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
measure: Maximum Observed Serum Drug Concentration (Cmax) of MEDI9314
timeFrame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
measure: Time to Maximum Observed Serum Drug Concentration (Tmax) of MEDI9314
timeFrame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
measure: Terminal Phase Elimination Half-life (t1/2) of MEDI9314
timeFrame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
measure: Serum Concentrations of MEDI9314
timeFrame: Baseline (Day 1 [predose]) and Day 240
measure: Number of Participants Positive for Anti-Drug Antibodies to MEDI9314
timeFrame: Baseline (Day 1 [predose]) and Day 240
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: California
city: Harrow
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Parexel
name: Muna Albayaty, MBChB, FFPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Parexel
name: Hakop Gevorkyan, MD
role: PRINCIPAL_INVESTIGATOR
References: