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

Healthy Adults Clinical Trial

Official title:

A Phase 1a, Randomised, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI7836 in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388347
• Other study ID #: D5450C00001
• Status: Completed
• Phase: Phase 1
• First received: March 9, 2015
• Last updated: May 16, 2016
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Registry
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Drug:
• Placebo SC
Liquid formulation

Biological:
• MEDI7836 SC Cohort 1
Liquid Formulation
• MEDI7836 SC Cohort 2
Liquid Formulation
• MEDI7836 SC Cohort 3
Liquid Formulation
• MEDI7836 SC Cohort 4
Liquid Formulation

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7836	Adverse events, serious adverse events, adverse events of special interest, and new onset of chronic disease.	281 days post dose	Yes
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7836	Clinical laboratory assessments (serum chemistry, hematology, urinalysis)	281 days post dose	Yes
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7836	12 Lead electrocardiogram (including QTc, QRS, PR intervals and ventricular rate)	281 days post dose	Yes
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7836	Vital signs (systolic and diastolic BP), heart rate	281 days post dose	Yes
Secondary	Pharmacokinetics of MEDI7836 in Serum	Area under the plasma drug concentration versus time curves from zero to infinity and to last observation (AUC0-inf; AUC0-t). This variable will be estimated for MEDI7836 in the subcutaneous cohorts where data allow.	281 days post dose	No
Secondary	Pharmacokinetics of MEDI7836 in Serum	Maximum observed plasma drug concentration (Cmax). This variable will be estimated for MEDI7836 in the subcutaneous cohorts where data allow.	281 days post dose	No
Secondary	Pharmacokinetics of MEDI7836 in Serum	Time to maximum observed plasma drug concentration (Tmax). This variable will be estimated for MEDI7836 in the subcutaneous cohorts where data allow.	281 days post dose	No
Secondary	Pharmacokinetics of MEDI7836 in Serum	Terminal plasma elimination half-life (t1/2). This variable will be estimated for MEDI7836 in the subcutaneous cohorts where data allow.	281 days post dose	No
Secondary	Pharmacokinetics of MEDI7836 in Serum	Apparent systemic clearance (CL/F). This variable will be estimated for MEDI7836 in the subcutaneous cohorts where data allow.	281 days post dose	No
Secondary	Pharmacokinetics of MEDI7836 in Serum	Apparent terminal-phase volume of distribution (Vz/F). This variable will be estimated for MEDI7836 in the subcutaneous cohorts where data allow.	281 days post dose	No
Secondary	The presence of anti-drug antibodies (ADAs) to MEDI7836	The incidence of anti-drug antibodies (a measure of the body's immune response to the drug). This variable will be estimated for MEDI7836 in the subcutaneous cohorts where data allow.	281 days post dose	No