VIS954 for Safety Evaluation in Healthy Subjects

Overseen By Clinical Trial Manager, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Visterra, Inc.

Must not be taking: Antidepressants, Antivirals, Antibiotics, others

Disqualifiers: Cardiovascular, Respiratory, Gastrointestinal, others

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of multiple doses of a new treatment, VIS954, compared to a placebo (a substance with no active drug) in healthy adults. The researchers seek to understand how the body processes VIS954 and its effects. Participants will receive varying doses of VIS954 or a placebo on specific days throughout the trial. This trial suits healthy individuals without major medical issues and not currently taking medications. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires that participants stop taking any prescription or over-the-counter medications 30 days before the trial, except for certain exceptions like acetaminophen, ibuprofen, hormonal contraceptives, topical medications, vitamins, and dietary or herbal remedies.

Is there any evidence suggesting that VIS954 is likely to be safe for humans?

Research has shown that VIS954 has undergone testing in earlier studies to assess its safety for humans. In one study, participants received a single dose of VIS954, and the results indicated that the treatment was generally well-tolerated. Some participants experienced mild side effects, but these were not serious.

In another study, healthy adults received multiple doses of VIS954. The treatment was again well-tolerated, with side effects similar to those seen with a single dose. These findings suggest that VIS954 is relatively safe for humans when administered in both single and multiple doses.

Since VIS954 remains in the early testing stages, researchers are focusing on understanding its safety and are closely monitoring for any side effects. As with any new treatment, some risk exists, but previous studies have not identified any major safety concerns with VIS954. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

VIS954 is unique because it offers a targeted approach by using a new active ingredient designed for subcutaneous delivery. Unlike standard treatments that might rely on generalized methods, VIS954 is administered directly under the skin, which can enhance precision and potentially reduce side effects. Researchers are excited about its ability to be administered in varying doses, allowing for tailored treatment options that can be adjusted based on patient response. This flexibility and targeted delivery system could set VIS954 apart from traditional treatments, offering new hope for more effective management of the condition being studied.

What evidence suggests that VIS954 could be effective?

Research shows that VIS954 is being tested for safety and efficacy in the body. In this trial, participants will receive varying doses of VIS954 or a placebo to assess its safety and effects. Earlier studies administered VIS954 to healthy individuals to evaluate tolerance and effects. The aim is to understand how the body processes the drug and its effects over time. Early testing has primarily ensured VIS954's safety for humans. Although direct proof of its effectiveness for a specific condition is not yet available, understanding its safety and behavior is a crucial first step in drug development. ^{1 2 3 4 5}

Who Is on the Research Team?

Peter J Winkle, MD

Principal Investigator

Anaheim Clinical Trials

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-55, with a BMI of 18.0-30.0 kg/m2 and weight between 50-120 kg. Participants must be able to consent, follow the trial's procedures, and agree to contraception measures. Exclusions include abnormal blood pressure, recent infections or vaccinations, chronic diseases, drug/alcohol abuse history, and involvement in other clinical studies.

Inclusion Criteria

Body mass index between 18.0 and 30.0 kg/m2 at the screening visit

Capable of giving signed informed consent and willing to comply with requirements

Willing and able to participate for the defined duration of the trial

Exclusion Criteria

Chronic infectious diseases, recent blood or plasma donation

COVID-19 related criteria

I have had recent issues with blood pressure, infections, or vaccinations.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 doses of VIS954 or placebo administered subcutaneously every 2 weeks

12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VIS954

Trial Overview The study tests VIS954 against a placebo in healthy participants to assess its safety and how it's processed by the body (pharmacokinetics) as well as its effects on bodily functions (pharmacodynamics). The comparison aims to determine if there are any differences between multiple doses of VIS954 and an inactive substance.

How Is the Trial Designed?

Group I: VIS954 - Medium Dose Experimental Treatment 1 Intervention

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

Group II: VIS954 - Low Dose Experimental Treatment 1 Intervention

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

Group III: VIS954 - High Dose Experimental Treatment 1 Intervention

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

Group IV: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Visterra, Inc.

Lead Sponsor

Trials

8

Recruited

650+

Published Research Related to This Trial

Visual electrophysiological techniques like electroretinography (ERG) and visual evoked potentials (VEP) are valuable tools for assessing the safety and efficacy of new ophthalmic drug therapies during their development and post-marketing phases.

These techniques can objectively measure patient responses to eye medications and detect side effects from non-eye-related drugs, highlighting their importance in monitoring ocular health throughout the drug lifecycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of drug development with special emphasis on the role of visual electrophysiological testing. Brigell, M., Dong, CJ., Rosolen, S., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06212804

NCT06212804 | A Study to Investigate the Safety ... 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, ...

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-2-2025-3a875

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

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06937593

A Study to Evaluate Safety, Pharmacokinetics (PK), and ... The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of VIS954 compared with placebo in healthy adult ...

4. ctv.veeva.com ctv.veeva.com/study/a-study-to-investigate-the-safety-pharmacokinetics-and-pharmacodynamics-of-vis954-in-healthy-adult

A Study to Investigate the Safety, Pharmacokinetics, and ... A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants. V. Visterra. Status and phase.

5. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06212804/

Trial | NCT06212804 The study will be conducted in 6 sequential cohorts. Each cohort will enroll 9 participants, randomized to VIS954 or placebo at a ratio of 7:2. On Day 1, a ...