Conditions: Healthy Adults
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 79
Healthy volunteers: yes

Brief 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.

Detailed 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).

Arms:
arm 1: Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1. arm 2: Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1. arm 3: Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1. arm 4: Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1. arm 5: Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.

Interventions: intervention 1: Placebo SC intervention 2: MEDI7836 Dose 1 intervention 3: MEDI7836 Dose 2 intervention 4: MEDI7836 Dose 3 intervention 5: MEDI7836 Dose 4
Intervention descriptions: intervention 1: Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1. intervention 2: Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1. intervention 3: Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1. intervention 4: Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1. intervention 5: Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.

Protocol document: