A Study to Evaluate Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Multiple Doses of VIS954

NCT06937593 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: VIS954-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of VIS954 compared with placebo in healthy adult participants.

Conditions

Healthy

Keywords

Monoclonal antibody

Outcome Measures

Primary Outcomes (3)

• Incidence of treatment-emergent adverse events (TEAEs)

  Number and Percentage of Adverse Events (AEs) that first occurred or worsened in severity after the study intervention administration.

  169 days

• Maximum serum concentration after administration of VIS954 over time

  Blood samples will be collected for measurement of serum concentrations of VIS954 at specified time points to assess maximum serum concentration over time

  169 days

• Area under the concentration-time curve from time zero extrapolated to time t

  Blood samples will be collected for measurement of serum concentrations of VIS954 at specified time points to assess area under the concentration-time curve from time zero extrapolated to time t (AUC 0-t)

  169 days

Secondary Outcomes (1)

• VIS954 Percentage Receptor Occupancy

  169 days

Study Arms (4)

VIS954 - Low Dose

EXPERIMENTAL

VIS954 Low Dose will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71

Drug: VIS954

VIS954 - Medium Dose

EXPERIMENTAL

VIS954 Medium Dose will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71

Drug: VIS954

VIS954 - High Dose

EXPERIMENTAL

VIS954 High Dose will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71

Drug: VIS954

Placebo

PLACEBO COMPARATOR

Placebo will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71

Drug: Placebo

Interventions

VIS954 DRUG

A humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)

VIS954 - High Dose; VIS954 - Low Dose; VIS954 - Medium Dose

Placebo DRUG

VIS954 Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female participant between 18 and 55 years of age, inclusive, at the screening visit.
• 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 in this protocol.
• Willing and able to participate in the trial for the defined duration of the trial.
• 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 trial enrollment until 90 days after Week 20 (or the last dose); women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test at screening.
• Male participants must agree to use double barrier contraception or abstain from sex during the trial and until 90 days after Week 20 (or the last dose). Male participants must agree to refrain from sperm donation for the duration of the trial and until 150 days after the last dose. This criterion may be waived for male participants who have had a vasectomy greater than 6 months prior to enrollment.
• Healthy, as determined by pretrial medical evaluation (medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests), as judged by the principal investigator.

You may not qualify if:

• Participant is participating in another clinical trial 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.
• Receipt of blood products within 6 months prior to screening.
• History of a previous hypersensitivity or severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any of the ingredients of the VIS954 subcutaneous (SC) injection formulation.
• Previous exposure to VIS954.
• Blood pressure \> 140/90 mmHg or \< 90/60 mmHg (may be repeated once if abnormal), at the screening visit or Day -1.
• History of any infection requiring hospitalization or treatment with antivirals, antibiotics, or systemic antifungals within 3 months prior to screening.
• Received a vaccination, other than Coronavirus Disease 2019 (COVID-19) vaccination, during the 30 days prior to administration of the first dose of study intervention. A COVID-19 vaccination cannot be received within 7 days prior to the first dose of study intervention and until 14 days after the last dose.
• Has received any prescription or nonprescription (over-the-counter) medication during the last 30 days or 5 half-lives, whichever is longer, preceding baseline (Day -1), with the exception of acetaminophen, ibuprofen, naproxen (or other over-the-counter nonsteroidal anti-inflammatory drugs \[NSAID\]), hormonal contraceptives, topical medications, vitamins, and dietary or herbal remedies.
• Any participant who has a recent history of alcohol or drug/chemical abuse, at the discretion of the investigator, will be excluded.
• For the duration of the trial, enrolled male participants should not consume more than 15 standard drinks per week (7 days) and female participants should not consume more than 10 standard drinks per week (7 days). A standard drink equals 10 g of alcohol. Enrolled participants must abstain from consuming alcohol 48 hours prior to each administration of study intervention.
• Enrolled participants must abstain from consumption of nicotine containing products from Day-1 through discharge from the trial site clinic (Day 3).
• Enrolled participants must abstain from consumption of cannabinoids from Day-1 through end of trial.
• Any chronic infectious disease (eg, chronic urinary tract infection, chronic sinusitis, bronchiectasis, active pulmonary or systemic tuberculosis \[TB\], chronic viral hepatitis such as hepatitis C or hepatitis B, or human immunodeficiency virus \[HIV\] infection).
• Participant who has donated \> 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).

Sponsors & Collaborators

• Visterra, Inc.: lead

Study Sites (1)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Study Officials

• Peter J Winkle, MD

  Anaheim Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 22, 2025
• Study Start: March 13, 2025
• Primary Completion: January 6, 2026
• Study Completion: February 13, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

US (1)