Clinical Pharmacology of Miami, Inc
Hialeah, Florida, 33014, United States
NCT Number: NCT04578535
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.
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Notify Me19 year–50 year
All sexes
Interventional
Phase 1
Hialeah, Florida, 33014, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
Time frame: From start of the study drug administration up to Week 9
A tolerability event was considered to have occurred if an infusion was tolerable. An infusion was considered tolerable if the infusion rate was not reduced, or the infusion was not interrupted or stopped, due to an adverse event (AE) related to HYQVIA infusion. Tolerability was measured in terms of the number of participants for which the infusions was tolerable. Number of participants who tolerated all initiated HYQVIA Infusion were reported.
Time frame: From start of the study drug administration up to Week 25
Treatment-emergent adverse events (TEAE) were defined as any event not present prior to the initiation of the treatments or any event already present that worsened in either intensity or frequency following exposure to the treatments. Number of participants with TEAEs was reported.
Time frame: From start of the study drug administration up to Week 25
Binding antibodies are responsible for binding to a pathogen and alerting the immune system to its presence so white blood cells can be sent to destroy it. The antibody level (titer) in the blood tells health care provider whether or not participant been exposed to an antigen, or something that the body thinks is foreign. A neutralizing antibody (NAb) is an antibody that is responsible for defending cells from pathogens, which are organisms that cause disease. The number of participants who developed binding and neutralizing antibodies to rHuPH20 were reported.
Time frame: Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6
Tmax was a measure of the time to reach the maximum concentration in the plasma after the drug dose. Summarized baseline corrected data was reported.
Time frame: Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6
Cmax was a measure of the maximum amount of drug in the serum after the dose is given. Summarized baseline corrected data was reported.
Time frame: Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6
AUClast was a measure of the total amount of drug in the plasma from time zero to time of the last measurable concentration. Summarized baseline corrected data was reported.
Time frame: Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6
T1/2 was the time required for a given drug concentration in the plasma to decrease by 50%. Summarized baseline corrected data was reported.
Time frame: Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6
Apparent clearance was a calculation of the rate at which a drug is removed from plasma after oral administration via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Summarized baseline corrected data was reported.
Time frame: Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6
Volume of distribution (Vz/F) was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed. Summarized baseline corrected data was reported.
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Industry
A Phase 1, Open-Label, Randomized 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 Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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