A Study Comparing the Pharmacokinetics and Tolerance of D-Gam® to Rhophylac® in Rh-D-negative Healthy Volunteers.

Bio Products Laboratory

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Rhophylac® (human anti-D immunoglobulin); Biological: D-Gam® (human anti-D immunoglobulin)

Study type: Interventional

Funder types: Other

Identifiers

NCT02246842

POLYAD04

Details and patient eligibility

About

The primary objective of the study was to compare peak serum anti-D levels (Cmax) of BPL's D-Gam® 1500 IU to Rhophylac® 1500IU in RhD-negative healthy volunteers.

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Females
• Ages of 18 and 55 years
• Bodyweight of 50-85kg.

Exclusion criteria

• Clinically relevant abnormalities at physical examination, ECG or laboratory tests.

Trial design

0 participants in 2 patient groups

D-Gam®

Experimental group

Description:

D-Gam® (human anti-D immunoglobulin)

Treatment:

Biological: D-Gam® (human anti-D immunoglobulin)

Rhophylac®

Active Comparator group

Description:

Human Anti-D Immunoglobulin

Treatment:

Biological: Rhophylac® (human anti-D immunoglobulin)