A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the tolerability, safety, and pharmacokinetics of
      HYQVIA with ramp-up and no ramp-up dosing in healthy adult participants.
    

Detailed description: 
      This study will comprise of Part 1 and Part 2. Each study part will consist of three
      treatment arms (Part 1 [approximately 24 participants]: Treatment Arms 1-3 and Part 2
      [approximately 24 participants]: Treatment Arms 4-6). Treatment arms will be initiated in
      parallel within each study part. Each participant will participate in only one treatment arm.
      After participants in Treatment Arms 1-3 (Study Part 1) will complete Week 9, the
      tolerability and, safety data through Week 9 will be reviewed by a safety review team.
      (Participants in arms 1-3 will continue in the study as the safety review is being
      completed.) Once the safety review for Arms 1-3 (Study part 1) will be completed and
      approved, Treatment Arms 4-6 (Study Part 2) will begin.
    

Intervention name(s): HYQVIA; HYQVIA; HYQVIA; HYQVIA; HYQVIA; HYQVIA
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.; Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.; Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.; Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.; Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.; Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
Other intervention name(s): IGI 10% with rHuPH20; Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase; IGI 10% with rHuPH20; Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase; IGI 10% with rHuPH20; Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase; IGI 10% with rHuPH20; Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase; IGI 10% with rHuPH20; Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase; IGI 10% with rHuPH20; Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science