A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults

MedImmune

Status and phase: Completed; Phase 1

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: MEDI8897 Intramuscular; Drug: MEDI8897 Intravenous; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02114268

D5290C00001

Details and patient eligibility

About

The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy adult participants.

Full description

This was a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of MEDI8897 compared to placebo when administered to healthy adult participants. There were 136 participants randomized to receive MEDI8897 or placebo at one site. Investigational product was delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts. 4 different dose levels of investigational product were evaluated across the 5 cohorts. Participants were followed for approximately 1 year.

Enrollment: 342 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Age 18 through 49 years and in good health by history, physical exam, and labs
• Weight greater than or equal to (>=) 45 kilogram (kg) and less than or equal to (<=) 110 kg at Screening
• Written informed consent prior to performing any protocol related procedures, including Screening evaluations
• Ability to complete the Follow-up period of 360 days

Key Exclusion Criteria:

• Acute illness including fever >= 99.5 Fahrenheit (°F) on day of dosing
• Any drug therapy within 7 days prior to Day 1 (except contraceptives)
• Receipt of any investigational drug therapy within 120 days prior to investigational product dosing through 360 days after investigational product dosing
• Previous receipt of a monoclonal antibody (mAb)
• Pregnant or nursing mother
• Concurrent enrollment in another interventional study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

342 participants in 6 patient groups, including a placebo group

MEDI8897 300 milligram (mg) Intravenous (IV)

Experimental group

Description:

Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.

Treatment:

Drug: MEDI8897 Intravenous

Drug: MEDI8897 Intravenous

Drug: MEDI8897 Intravenous

MEDI8897 1000 mg IV

Experimental group

Description:

Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.

Treatment:

Drug: MEDI8897 Intravenous

Drug: MEDI8897 Intravenous

Drug: MEDI8897 Intravenous

MEDI8897 3000 mg IV

Experimental group

Description:

Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.

Treatment:

Drug: MEDI8897 Intravenous

Drug: MEDI8897 Intravenous

Drug: MEDI8897 Intravenous

MEDI8897 100 mg Intramuscular (IM)

Experimental group

Description:

Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.

Treatment:

Drug: MEDI8897 Intramuscular

Drug: MEDI8897 Intramuscular

MEDI8897 300 mg IM

Experimental group

Description:

Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Treatment:

Drug: MEDI8897 Intramuscular

Drug: MEDI8897 Intramuscular

Placebo

Placebo Comparator group

Description:

Participants received placebo on Day 1.

Treatment:

Drug: Placebo