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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How does the drug VIS954 differ from other drugs for this condition?

VIS954 is unique because it is being evaluated for safety in healthy subjects, which suggests it may have a novel mechanism or application compared to existing treatments. The use of standardized electroretinography in its evaluation highlights a focus on assessing potential ocular side effects, which may not be as emphasized in other treatments. ^{1 2 3 4 5}

Research Team

Peter J Winkle, MD

Principal Investigator

Anaheim Clinical Trials

Eligibility Criteria

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

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

Healthy as determined by pretrial medical evaluation

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

Exclusion Criteria

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

Chronic infectious diseases, recent blood or plasma donation

COVID-19 related criteria

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Standardized electroretinography in primates: a non-invasive preclinical tool for predicting ocular side effects in humans. [2005]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized, double-masked, placebo-controlled study to assess the ocular safety of mirabegron in healthy volunteers. [2013]

3. Japan pubmed.ncbi.nlm.nih.gov

General considerations in ocular toxicity risk assessment from the toxicologists' viewpoints. [2015]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

An overview of drug development with special emphasis on the role of visual electrophysiological testing. [2018]