A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers

MedImmune

Status and phase: Completed; Phase 1

Conditions: Asthma; Healthy Subjects or Volunteers

Treatments: Biological: Tralokinumab 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02085473

D2210C00011

Details and patient eligibility

About

The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.

Full description

This is a Phase 1, open-label, assessor-blind, parallel-group study to evaluate the PK and tolerability of a single subcutaneous dose of 300 milligram (mg) tralokinumab when delivered as a 2 milliliters (mL) injection at different flow rates to healthy adult volunteers.

Enrollment: 60 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Healthy males and females ages 19-65 years
• Body mass index of 19.0-30.0 kilogram per meter square (kg/m^2)
• No clinically significant abnormality
• Vital signs, electrocardiogram (ECG), and laboratory parameters within normal range
• Negative alcohol and drug screens
• Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception
• Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective contraception.

Key Exclusion Criteria:

• Concurrent enrollment in another clinical study where the subject is receiving an investigational product
• Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer
• Receipt of any investigational nonbiologic agent within 3 months or 5 half-lives prior to screening, whichever is longer
• Current use of regular pain-modifying, anti-depressant, anxiolytic, or hypnotic medication
• History of thrombocytopenia or bleeding disorder or use of anticoagulants
• History of any immunodeficiency disorder or use of immunosuppressive medication.
• History of a clinically significant infection
• History of cancer
• Positive Hepatitis B or C
• Positive HIV

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Cohort 1

Active Comparator group

Description:

Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'W' mL/min.

Treatment:

Biological: Tralokinumab 300 mg

Cohort 2

Experimental group

Description:

Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'X' mL/min.

Treatment:

Biological: Tralokinumab 300 mg

Cohort 3

Experimental group

Description:

Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'Y' mL/min.

Treatment:

Biological: Tralokinumab 300 mg

Cohort 4

Experimental group

Description:

Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'Z' mL/min.

Treatment:

Biological: Tralokinumab 300 mg