Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults

MedImmune

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Biological: MEDI4920 1000 mg; Biological: MEDI4920 30 mg; Biological: MEDI4920 100 mg; Biological: MEDI4920 300 mg; Biological: MEDI4920 3000 mg; Other: Placebo; Biological: MEDI4920 3 mg; Biological: MEDI4920 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02151110

D5100C00001

Details and patient eligibility

About

Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920

Enrollment: 59 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy as determined by a responsible study physician based on medical evaluation
• Body weight 40 to 100 kg
• Body mass index 19.0 to 30.0 kg/m2

Exclusion criteria

• History of allergy or sensitivity to Shellfish or protein based antigens
• previous immunization with KLH
• previous splenectomy
• History of diagnosed or suspected thromboembolic event or coagulation disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 8 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.

Treatment:

Other: Placebo

MEDI4920 3 mg

Experimental group

Description:

Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.

Treatment:

Biological: MEDI4920 3 mg

MEDI4920 10 mg

Experimental group

Description:

Participants received single IV dose of MEDI4920 10 mg infused on Day 1.

Treatment:

Biological: MEDI4920 10 mg

MEDI4920 30 mg

Experimental group

Description:

Participants received single IV dose of MEDI4920 30 mg infused on Day 1.

Treatment:

Biological: MEDI4920 30 mg

MEDI4920 100 mg

Experimental group

Description:

Participants received single IV dose of MEDI4920 100 mg infused on Day 1.

Treatment:

Biological: MEDI4920 100 mg

MEDI4920 300 mg

Experimental group

Description:

Participants received single IV dose of MEDI4920 300 mg infused on Day 1.

Treatment:

Biological: MEDI4920 300 mg

MEDI4920 1000 mg

Experimental group

Description:

Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.

Treatment:

Biological: MEDI4920 1000 mg

MEDI4920 3000 mg

Experimental group

Description:

Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.

Treatment:

Biological: MEDI4920 3000 mg