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Phase 1 Completed N=51 Randomized Basic Science

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

Healthy Volunteers
Source: ClinicalTrials.gov NCT04578535 ↗
Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Number of Participants Who Tolerated All Initiated HYQVIA Infusion — 7; 8; 8; 9 Participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Who Tolerated All Initiated HYQVIA Infusion
7; 8; 8; 9; 8; 10
SECONDARY
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
8; 8; 8; 9; 8; 10
SECONDARY
Number of Participants Who Developed Binding and Neutralizing Antibodies to Recombinant Human Hyaluronidase PH20 (rHuPH20)
2; 3; 2; 1; 1; 2
SECONDARY
Time of Maximum Observed Serum Concentration (Tmax) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
5.0; 4.0; 8.0; 6.0; 4.0; 6.0
SECONDARY
Maximum Observed Serum Concentration (Cmax) Sampled During a Dosing Interval of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
2.70; 3.17; 3.10; 5.71; 5.34; 12.75
SECONDARY
Area Under the Curve From the Time of Dosing to the Last Time Point With Measurable Concentration (AUClast) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
9.63; 9.49; 31.60; 42.48; 70.39; 117.69
SECONDARY
Terminal Half-Life (T1/2) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
8.1
SECONDARY
Apparent Total Clearance After Extravascular Administration (CL/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
0.01
SECONDARY
Apparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration (Vz/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
0.07

Eligibility Criteria

Inclusion Criteria

  • An understanding, ability, and willingness to fully comply with study procedures and restrictions
  • Ability to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent to participate in the study
  • Age 19-50 years inclusive at the time of consent. The date of signature of the informed consent is defined as the beginning of the screening period. This inclusion criterion will only be assessed at the first screening visit
  • Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable contraceptive requirements of the protocol, or females of non-childbearing potential
  • Must be considered "healthy". Healthy as determined by the investigator on the basis of screening evaluations and healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electro cardiogram (ECG), hematology, blood chemistry, and urinalysis
  • Body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2) inclusive

Exclusion Criteria

  • Any current or relevant history of medical (e.g. any hematological, hepatic, respiratory, cardiovascular, renal or neurological) or psychiatric conditions, which by judgment of the investigator might compromise the safety of the participant or integrity of the study, interfere with the participant's participations in the trial and compromise the trial objectives or any condition that presents undue risk from the investigational product or procedures Note: Participants on stable dose of hormone replacements (i.e. thyroid hormone replacement) or oral contraceptives are permitted
  • Clinically significant cardiac conditions including but not limited to uncontrolled hypertension, myocardial infarction, unstable coronary artery disease and clinically significant arrhythmias and conduction disorders
  • Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients (e.g. human IG, hyaluronidase, albumin)
  • Known history of hypersensitivity or severe allergic reactions (e.g. urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following administration of blood or blood components
  • Significant illness, as judged by the investigator, within 30 days of the first dose of investigational product
  • Known history of alcohol or other substance abuse within the last year
  • Donation of blood within 60 days, or blood products (e.g., plasma or platelets) within 2 weeks prior receiving the first dose of investigational product
  • Participants will be excluded if any of the following laboratory parameters meet the criteria below:
  • Hemoglobin less than ( or =2.5 × upper limit normal (ULN), aspartate aminotransferase (AST) > or =2.5 × upper limit normal (ULN), alkaline phosphatase > or =1.5 × ULN or total bilirubin > or =1.5 milligram per deciliter (mg/dL) Renal function: creatinine clearance 1.2 X ULN; international normalized ratio (INR) >1.2 Participants will be excluded if any other laboratory values are outside the reference range and are clinically significant per investigator's judgment.
  • Within 30 days prior to the first dose of investigational product:
  • Has participated in another clinical study involving immunoglobulin products within 12 months of screening.
  • Have used an investigational product (or 5 half-lives, whichever is longer).
  • Have been enrolled in a clinical study (including vaccine studies or has been vaccinated with approved product) that, in the investigator's opinion, may impact this study. Participants who have received any vaccine (including live attenuated vaccines) during the last 30 days before dosing will be excluded. No live attenuated virus vaccines are allowed during the study until the end of the follow up period
  • Have had any substantial changes in eating
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04578535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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