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This study is primarily designed to assess the safety and tolerability of single doses of VEL-101 when administered subcutaneously (via injection into an area under the skin) or intravenously (via infusion into a vein). As each new group of participants is enrolled into the study, the dose administered to that group may be higher than a previous dose shown to be safe in other participants. The study is also designed to determine blood levels of VEL-101 and some substances produced by the immune system following VEL-101 administration. This information can provide insight into how quickly VEL-101 is eliminated from the body and some if its effects on the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous (SQ) Dose "A" | Experimental | Single dose of VEL-101 by SQ injection |
|
| Intravenous (IV) Dose "A" | Experimental | Single dose of VEL-101 by IV infusion |
|
| SQ Dose "B" | Experimental | Single dose of VEL-101 by SQ injection |
|
| SQ Dose "C" | Experimental | Single dose of VEL-101 by SQ injection |
|
| IV Dose "C" | Experimental | Single dose of VEL-101 by IV infusion |
|
| SQ Dose "D" | Experimental | Single dose of VEL-101 by SQ injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VEL-101 | Drug | Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) | Number and percentage of participants experiencing one or more adverse events which occurred or worsened in severity after initiation of investigational product (IP) dosing | Day 1 through Day 50 |
| Number and Percentage of Participants with Serious TEAEs | Number and percentage of participants experiencing one or more serious TEAEs | Day 1 through Day 50 |
| Number and Percentage of Participants with Grade 3 or Higher TEAEs | Number and percentage of participants experiencing one or more grade 3 TEAEs | Day 1 through Day 50 |
| Number and Percentage of Participants with TEAEs Leading to Withdrawal from the Study | Number of participants experiencing one or more TEAEs directly resulting in withdrawal from the study | Day 1 through Day 50 |
| Number and Percentage of Participants with TEAEs Leading to Death | Number and percentage of participants experiencing TEAEs that resulted in death | Day 1 through Day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants with Abnormal Chemistry Panel Results | Descriptive statistics will summarize results (including change from baseline, as appropriate) of the following at each time point: sodium, potassium, chloride, calcium, bicarbonate, glucose, phosphorus, blood urea nitrogen, creatinine, creatine kinase, C-reactive protein, estimated glomerular filtration rate (eGFR), magnesium, amylase, uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), albumin, alkaline phosphatase, direct bilirubin, total bilirubin, indirect bilirubin, total protein, and lactate dehydrogenase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Libbie McKenzie, MD | Veloxis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42083151 | Derived | Tremblay S, Abaigar A, Allton P, Sardinha D, Patel SJ, Shah K, Maynard J, Otulana B. Safety, Pharmacokinetics, and Pharmacodynamics of Fixed-dose, Subcutaneous, and Intravenous Administration of VEL-101, an Anti-CD28 PEGylated Monoclonal Antibody Fragment, in Healthy Participants: A Randomized, Double-blind, Placebo-controlled, Dose Escalation, Phase 1 Study. Transplantation. 2026 Jun 1;110(6):e1308-e1316. doi: 10.1097/TP.0000000000005701. Epub 2026 May 4. |
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| SQ Dose "E" |
| Experimental |
Single dose of VEL-101 by SQ injection |
|
| SQ or IV Placebo | Placebo Comparator | Single dose of Placebo by SQ injection or IV infusion |
|
| Placebo | Drug | Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1 |
|
| Days -1, 2 (24 hours), 3, 5, 8, 15, 22, 29, 50 |
| Number and Percentage of Participants with Abnormal Hematology Panel Results | Descriptive statistics will summarize results (including change from baseline, as appropriate) of the following at each time point: hematocrit, hemoglobin, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), red blood cells (RBC), white blood cells (WBC) and differential, and platelets | Days -1, 2 (24 hours), 3, 5, 8, 15, 22, 29, 50 |
| Number and Percentage of Participants with Abnormal Coagulation Panel Results | Descriptive statistics will summarize results (including change from baseline, as appropriate) of the following at each time point: prothrombin time (PT), international normalized ratio (INR), partial thromboplastin time (PTT), and fibrinogen | Days -1, 2 (24 hours), 3, 5, 8, 15, 22, 29, 50 |
| Number and Percentage of Participants with Abnormal Urinalysis Results | Descriptive statistics will summarize results (including change from baseline, as appropriate) of the following at each time point: specific gravity, pH, leukocytes, erythrocytes, protein, glucose, nitrite, urobilinogen, bilirubin, ketones, and additional microscopic examination if blood or protein are abnormal | Days -1, 2 (24 hours), 3, 5, 8, 15, 22, 29, 50 |
| Number and Percentage of Participants with Abnormal 12-lead Electrocardiogram (ECG) Results | Descriptive statistics will summarize results (including change from baseline, as appropriate) of the following at each time point: PR interval, QRS duration, QT interval, corrected QT interval (QTc), and corrected QT interval using Fridericia's formula (QTcF) | Days 1 (0, 1, 2, 3, 4, 5, 8, 12, 12, 16, and 20 hours), 2 (24, 30, 36, and 42 hours), 3, 4, 5, 8, 29, 50 |
| Number and Percentage of Participants with Abnormal Vital Signs Results | Descriptive statistics will summarize results (including change from baseline, as appropriate) of the following at each time point: heart rate (HR), respiratory rate (RR), blood pressure (BP), temperature, and oxygen saturation | Days -1, 1 (0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 8, 12, 16, 20 hours), 2 (24, 30, 36, 42 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 |
| CD28 Receptor Occupancy | Proportion of target receptors occupied by VEL-101 | Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 15, 22, 29, 50 |
| Number and Percentage of Participants with Anti-drug Antibody (ADA) Formation | Presence of detectable anti-VEL-101 antibodies; neutralizing antibody assessments to be performed in samples positive for ADA | Days 1 (0 hour), 15, 29, 50 |
| Number and Percentage of Participants with Detectable Systemic Cytokine Concentrations | Interferon-gamma, interleukin-1 beta, interleukin-2, interleukin-4, interleukin-5, interleukin-6, interleukin-8, interleukin-10, interleukin-13, interleukin-17, interleukin-12 p70 (heterodimer composed of p40 and p35 subunits), tumor necrosis factor-alpha | Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 15, 50 |
| Maximum Plasma Concentration (Cmax) | The observed maximum plasma concentration | Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 |
| Time of Observed Maximum Plasma Concentration (Tmax) | Time at which the observed maximum plasma concentration occurred | Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 |
| Terminal Elimination Rate Constant | Terminal elimination rate constant, determined using the linear least squares regression of the terminal phase of the log plasma concentration time profile | Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 |
| Terminal Elimination Half-life | Elimination half-life calculated using terminal phase plasma concentration data | Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 |
| Area Under the Plasma Concentration Versus Time Curve (AUC) from Time Zero to Time of Last Observed Quantifiable Concentration | Area under the plasma concentration versus time curve (AUC) from time zero to time of last observed quantifiable concentration (different from AUC from time zero to infinity) | Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 |
| AUC from Time Zero to Infinity | Area under the plasma concentration versus time curve from time zero to infinity | Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 |
| Total Clearance (CL) | Total clearance from plasma | Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 |
| Terminal Volume of Distribution (Vz) | Apparent volume of distribution in the terminal phase | Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 |
| Bioavailability (F) | Absolute bioavailability | Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 |