Phase 1
Completed N=24
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants
Source: ClinicalTrials.gov NCT05291520 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Number of Participants With Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3) — 7; 8 Participants
Summary
An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed up for 24 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3) |
7; 8 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) Following SC Administration of VH3810109 (Part 1 and Part 3) |
0; 0 | — |
| PRIMARY Number of Participants With Injection Site Reactions (ISRs) Following VH3810109 SC Administration (Part 1 and 3) |
7; 8 | — |
| PRIMARY Number of Participants With Grade 2 to 4 Elevated Alanin Aminotransferase/Aspartate Aminotransferase (ALT/AST) Values Following VH3810109 SC Administration (Part 1 and 3) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With >= Grade 2 AEs Following IV Administration of VH3810109 (Part 2) |
— | — |
| PRIMARY Number of Participants With SAEs Following IV Administration of VH3810109 (Part 2) |
— | — |
| PRIMARY Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) of VH3810109 |
7587; 31560; 12840 | — |
| SECONDARY AUC From Time Zero to Time t (AUC[0-t]) of VH3810109 |
6996; 29160; 11590 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of VH3810109 |
148.2; 1864; 321.1 | — |
| SECONDARY Time of Maximum Observed Concentration (Tmax) of VH3810109 |
4.503; 0.046; 2.882 | — |
| SECONDARY Apparent Terminal Phase Half-life (t1/2) of VH3810109 |
38.17; 46.97; 44.95 | — |
| SECONDARY Score Recorded for "Acceptance of ISRs", Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) |
1.44; 1.44; 1.44; 1.50 | — |
| SECONDARY Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) |
6; 6; 2; 2; 0; 0 | — |
| SECONDARY Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) |
7; 6; 0; 1; 0; 1 | — |
| SECONDARY Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3) |
3.63; 2.75; 3.63; 0.63; 3.63; 0.38 | — |
| SECONDARY Scores Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 IV Administration (Part 2) |
0.50; 0.88; 0.50 | — |
| SECONDARY Number of ISRs Events Overall and by Grade (Part 1 and 3) |
14; 18; 2; 6; 5; 2 | — |
| SECONDARY The Overall Duration of ISRs, Expressed in Days |
2.9; 4.6 | — |
| SECONDARY Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils |
0.033; 0.035; 0.044; -0.004; 0.000; -0.009 | — |
| SECONDARY Change From Baseline in Hematocrit |
0.3873; 0.3928; 0.4253; 0.0159; 0.0005; 0.0118 | — |
| SECONDARY Change From Baseline in Hemoglobin, Albumin and Total Protein |
131.4; 128.3; 142.4; 5.8; 1.9; 3.9 | — |
| SECONDARY Change From Baseline in Red Blood Cell Count (RBC) |
4.518; 4.523; 4.889; 0.180; 0.043; 0.141 | — |
| SECONDARY Change From Baseline in Mean Corpuscle Volume (MCV) |
85.78; 86.89; 87.28; 0.14; -0.66; -0.03 | — |
| SECONDARY Change From Baseline in Mean Corpuscle Hemoglobin (MCH) |
29.05; 28.33; 29.26; 0.20; 0.21; -0.08 | — |
| SECONDARY Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin |
5.009778; 5.037533; 4.864064; -0.006939; 0.256734; 0.145714 | — |
| SECONDARY Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide |
2.329706; 2.317231; 2.351538; -0.015594; -0.003119; -0.003119 | — |
| SECONDARY Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) |
11.8; 12.5; 20.0; 0.6; -0.5; -1.8 | — |
| SECONDARY Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline |
1; 0; 0; 0; 1; 1 | — |
| SECONDARY Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) |
161.375; 164.000; 164.875; -4.000; 0.500; -0.208 | — |
| SECONDARY Change From Baseline in Temperature |
36.54; 36.79; 36.49; -0.10; -0.48; -0.14 | — |
| SECONDARY Change From Baseline in Pulse Rate |
73.9; 71.1; 75.9; -4.4; -7.6; -13.8 | — |
| SECONDARY Change From Baseline in Respiratory Rate |
15.5; 15.8; 13.8; -1.4; -0.3; 2.0 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
112.8; 106.3; 114.4; -4.1; 3.5; -4.5 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and without history of any of the conditions listed in the exclusion criteria.
- Participants having body weight of ≥50 kilogram (kg) and 1.5×ULN is acceptable if total bilirubin is fractionated and direct bilirubin 450 millisecond (msec) for males and QTcF >470 msec for females.
- The participant has a tattoo or other dermatological condition overlying potential injection sites that may interfere with interpretation of ISRs or administration of VH3810109.
- Grade 4 laboratory abnormalities.
- Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the subject including (but not limited to): diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of drug or alcohol abuse, asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer.
- Known hypersensitivity to hyaluronidase or any of the excipients in ENHANZ Drug Product (EDP)
Data sourced from ClinicalTrials.gov (NCT05291520). 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.