Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884

MedImmune

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: MEDI5884 Dose 4; Biological: MEDI5884 Dose 3; Biological: MEDI5884 Dose 2; Biological: MEDI5884 Dose 1; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03001297

D7870C00001

Details and patient eligibility

About

A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in healthy volunteers

Full description

This is a first time in human, phase 1, randomized, blinded, placebo-controlled study to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending subcutaneous doses of MEDI5884 in healthy volunteers (age 18-55). The study consists of 4 cohorts of increasing doses (8 subjects each) and an optional Japanese American cohort (24 subjects) for a total of 56 healthy subjects. The decision whether or not to dose escalate will be based upon data review by the Dose Escalation Committee. Subjects will be randomized 3:1 to MEDI5884 or placebo. Following screening, the study consists of a 3 day inpatient stay and follow up visits. The number of follow up visits depend on the cohort assigned.

Enrollment: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers aged 18-55 years
• Must provide written informed consent
• Ability and willingness to adhere to the protocol
• BMI 18-30kg/m2
• Females not of childbearing potential
• Males must practice 2 effective contraceptive measures if sexually active
• Japanese descent for the Japanese cohort

Exclusion criteria

• Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
• History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
• Abnormal lab values, physical exam, vital signs
• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
• Positive Hepatitis B, Hepatitis C or HIV test
• Receipt of investigational therapy with 4 months from screening
• Current or previous use of systemic corticosteroids 60 days prior to dosing or lipid lowering medications 28 days prior to dosing
• Abnormal ECG
• Recent plasma or blood donation
• Positive drug or alcohol screen.
• Current smoker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

64 participants in 5 patient groups, including a placebo group

MEDI5884 Dose 1

Experimental group

Description:

Participants will receive single dose of MEDI5884 Dose 1 injection SC on Day 1.

Treatment:

Biological: MEDI5884 Dose 1

Placebo

Placebo Comparator group

Description:

Placebo will be administered subcutaneously (SC).

Treatment:

Biological: Placebo

MEDI5884 Dose 2

Experimental group

Description:

Participants will receive single dose of MEDI5884 Dose 2 injection SC on Day 1.

Treatment:

Biological: MEDI5884 Dose 2

MEDI5884 Dose 3

Experimental group

Description:

Participants will receive single dose of MEDI5884 Dose 3 injection SC on Day 1.

Treatment:

Biological: MEDI5884 Dose 3

MEDI5884 Dose 4

Experimental group

Description:

Participants will receive single dose of MEDI5884 Dose 4 injection SC on Day 1.

Treatment:

Biological: MEDI5884 Dose 4