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Monoclonal Antibodies

VIS954 Dose 1 for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Visterra, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Total body weight between 50.0 and 120.0 kg, inclusive, at the screening visit
Male or female participant between 18 to 55 years of age, inclusive, at the screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 102 days
Awards & highlights

Study Summary

This trial is the first time that the drug VIS954 is being tested on humans. The study will have participants taking either the drug or a placebo, and neither the participants nor the researchers will know which

Who is the study for?
This clinical trial is open to healthy adult men and women. Specific eligibility criteria are not detailed, but typically participants should have no significant health issues.Check my eligibility
What is being tested?
The study is testing VIS954, a monoclonal antibody, in its first use in humans. It's compared with a placebo (a substance with no active drug) to see how safe it is and how the body reacts to it.See study design
What are the potential side effects?
Since this is a first-in-human study for VIS954, potential side effects are unknown but will be closely monitored against those receiving the placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight is between 50 and 120 kg.
Select...
I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~102 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 102 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-emergent adverse events
Secondary outcome measures
AUC 0-inf
AUC 0-last
Cmax
+4 more

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: VIS954 Dose 6Experimental Treatment1 Intervention
A single VIS954 Dose 6 will be administered subcutaneously on Day 1
Group II: VIS954 Dose 5Experimental Treatment1 Intervention
A single VIS954 Dose 5 will be administered subcutaneously on Day 1
Group III: VIS954 Dose 4Experimental Treatment1 Intervention
A single VIS954 Dose 4 will be administered subcutaneously on Day 1
Group IV: VIS954 Dose 3Experimental Treatment1 Intervention
A single VIS954 Dose 3 will be administered subcutaneously on Day 1
Group V: VIS954 Dose 2Experimental Treatment1 Intervention
A single VIS954 Dose 2 will be administered subcutaneously on Day 1
Group VI: VIS954 Dose 1Experimental Treatment1 Intervention
A single VIS954 Dose 1 will be administered subcutaneously on Day 1
Group VII: PlaceboPlacebo Group1 Intervention
A single Placebo dose will be administered subcutaneously on Day 1 for 2 participants in each cohort.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Visterra, Inc.Lead Sponsor
7 Previous Clinical Trials
583 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this study is currently seeking eligible participants. The trial was initially posted on November 22, 2023 and has been recently updated as of January 8, 2024. A total of 54 patients will be enrolled in this trial across a single location."

Answered by AI

What is the upper limit of participants involved in this clinical investigation?

"Indeed, the information available on clinicaltrials.gov confirms that this trial is presently seeking individuals to participate. The initial posting of this clinical trial occurred on November 22nd, 2023, and it was most recently updated on January 8th, 2024. A total of 54 participants will be enrolled from a single site."

Answered by AI

Is it possible for me to enroll as a participant in this research study?

"To be considered for participation in this clinical trial, individuals must meet the eligibility criteria of being healthy and between 18 to 55 years old. The study aims to enroll approximately 54 eligible candidates."

Answered by AI

Are individuals above the age of 75 being considered as participants in this trial?

"This clinical trial is currently seeking participants who are over 18 years of age but under the age of 55."

Answered by AI

Has the first dose of VIS954 received approval from the FDA?

"Due to the limited availability of safety and efficacy data, VIS954 Dose 1 has been assigned a rating of 1 on our scale."

Answered by AI

Who else is applying?

What site did they apply to?
Visterra Clinical Site
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Looking to make the world a better place.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants
2023. "A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06212804.
~24 spots leftby Sep 2024
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