Phase 1
N=54
A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT06212804 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) — 2; 1; 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- VIS954 (Biological); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
2; 1; 1; 1; 3; 2 | — |
| PRIMARY Wong-Baker FACES Pain Rating Scale |
0; 0; 0; 0.3; 0; 0 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of VIS954 |
0.0660; 1.961; 4.423; 16.82; 32.61 | — |
| SECONDARY Time of Maximum Serum Concentration (Tmax) of VIS954 |
48.00; 48.00; 71.82; 74.02; 95.60 | — |
| SECONDARY Area Under the Concentration-Time Curve From Pre-dose Extrapolated to Infinite Time (AUC0-inf) of VIS954 |
395; 1463; 5529; 11560 | — |
| SECONDARY Area Under the Concentration-Time Curve From Pre-dose to the Last Quantifiable Concentration (AUC0-last) of VIS954 |
3.17; 188.4; 872.4; 3604; 11470 | — |
| SECONDARY Apparent Terminal Elimination Half-Life (t1/2) of VIS954 |
85.25; 33.6; 48.0; 76.3 | — |
| SECONDARY Apparent Volume of Distribution (Vd/F) of VIS954 |
12.3; 10.12; 5.218; 8.536 | — |
| SECONDARY Apparent Clearance After Extravascular Dosing (CL/F) of VIS954 |
0.228; 0.1864; 0.06911; 0.07976 | — |
| SECONDARY Time Spent Above 40 Percentage Receptor Occupancy (RO) for Neutrophils |
0.0; 48.0; 239.2; 335.5; 503.1; 1008.1 | — |
Summary
This is a first-in-human (FIH), randomized, placebo-controlled, double-blind, single ascending dose (SAD) study to assess the safety and tolerability of VIS954, a monoclonal antibody, in healthy adult male and female participants.
Eligibility Criteria
Inclusion Criteria
- Male or female participant between 18 to 55 years of age, inclusive, at the screening visit.
- Non-Japanese participant: Participant does not meet the criteria specified below for 'Japanese Participant'.
- Japanese participant: Participant is of Japanese descent as evidenced by verbal confirmation of familial heritage (a participant's 4 grandparents were born in Japan and recognized to be 'Japanese').
- Body mass index between 18.0 and 30.0 kg/m2, inclusive, at the screening visit.
- Total body weight between 50.0 and 120.0 kg, inclusive, at the screening visit.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.
- Willing and able to participate in the study for the defined duration of the study.
- Female participants will be nonpregnant, nonlactating, and either postmenopausal for at least 1 year or surgically sterile for at least 3 months, or will agree to use highly effective methods of contraception from the period prior to study enrollment until 30 days after Day 56; women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test at screening and a negative urine pregnancy test at baseline prior to administration of the study intervention.
- Male participants with female partners of childbearing potential must agree to use double barrier contraception or abstain from sex during the study and until 90 days after Day 56. Male participants must agree to refrain from sperm donation for the duration of the study and until 90 days after Day 56. This criterion may be waived for male participants who have had a vasectomy greater than 6 months prior to enrollment.
- Healthy, as determined by prestudy medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations), as judged by the principal investigator.
Exclusion Criteria
- Participant has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, blood dyscrasias or other medical disorder, including psychiatric disorders, cirrhosis, or malignancy. History of minor skin cancers (not including melanoma) or surgically treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary.
- Participant is participating in another clinical study of any investigational drug, device, or intervention or has received any investigational medication during the last 30 days or 5 half-lives, whichever is longer, before baseline (Day -1).
- Previous receipt of antibody or biologic therapy.
- History of a previous hypersensitivity or severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any of the ingredients of the VIS954 SC injection formulation.
- Blood pressure > 160/100 mmHg or 500 mL of blood within 60 days prior to start of the screening visit or the participant has donated any plasma within 7 days prior to baseline (Day -1).
- Coronavirus disease 2019:
- Current symptoms of infection.
- Diagnosis of COVID-19 (reverse transcription polymerase chain reaction [RT-PCR], antigen testing, or clinical diagnosis) in the 21 days prior to screening.
- Ongoing diagnosis of "Long-COVID" symptoms, due to a prior COVID-19 infection.
- Is an employee of the clinical research team (any sponsor or research site employee), or has a family member who is an employee of these organizations.
- Participant is judged by the investigator or the medical monitor to be inappropriate for the study.
Data sourced from ClinicalTrials.gov (NCT06212804). 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.