65 Participants Needed

V118C Safety Study in Healthy Adults

Recruiting at 2 trial locations
TF
Overseen ByToll Free Number
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Merck Sharp & Dohme LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What safety data exists for V118C in humans?

The safety of V118C in humans has not been specifically addressed in the provided research articles. However, these studies highlight that adverse events in phase I trials are common and often unrelated to the drug being tested, emphasizing the importance of careful monitoring and ethical oversight in such trials.12345

What is the purpose of this trial?

The goal of this study is to learn how safe V118 Formulation C is in Healthy Adults and how well people tolerate it.

Research Team

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This clinical trial is for healthy adults who are in good health before being randomly assigned to a treatment group. Specific eligibility details aren't provided, but typically participants should not have any significant underlying health conditions.

Inclusion Criteria

Is in good health before randomization

Exclusion Criteria

I had a serious lung infection or other pneumococcal disease in the last 3 years.
I have a significant history of major health issues like heart, liver, or kidney diseases.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intramuscular injections in a 2-dose regimen on Day 1 and Day 29

4 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

  • V118C
Trial Overview The study is testing the safety and tolerability of V118 Formulation C (V118C) compared to PREVNAR 20™ and saline. Participants will be given one of these treatments to see how their bodies react.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: V118CExperimental Treatment1 Intervention
Participants receive intramuscular (IM) injection of V118C in a 2-dose regimen administered on Day 1 and Day 29.
Group II: V118Experimental Treatment2 Interventions
Participants receive IM injection of V118 in a 2-dose regimen administered on Day 1 and Day 29.
Group III: PREVNAR 20™ + SalineActive Control2 Interventions
Participants receive one dose of IM injection of PREVNAR 20™ in a 2-dose regimen on Day 1 followed by one dose of saline on Day 29.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

In a five-year analysis of 1,559 healthy volunteers across 142 phase I studies, the overall incidence of adverse events (AEs) was 8.8%, with most AEs being mild or moderate in severity, indicating that while AEs are common, they are generally not severe.
The incidence of AEs was significantly higher in multiple-dose studies compared to single-dose trials, highlighting the importance of study design in assessing the safety profile of active drugs, with a notable increase in AEs on the first day of drug administration.
Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects.Lutfullin, A., Kuhlmann, J., Wensing, G.[2019]
In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).
Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.
Adverse events in phase-I studies: a report in 1015 healthy volunteers.Sibille, M., Deigat, N., Janin, A., et al.[2019]
Pre-clinical studies in animals cannot be directly applied to humans, highlighting the necessity for thorough pre-therapeutical studies to understand how new drugs are absorbed, distributed, metabolized, and excreted (ADME) in humans.
Safety is the top priority in human clinical trials, which must follow approved protocols and be monitored closely, yet there are legal and ethical challenges in conducting studies with healthy volunteers in France, necessitating clearer legislation.
[Current practice of drug trials in healthy volunteers].Duchier, J.[2007]

References

Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. [2019]
Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]
[Current practice of drug trials in healthy volunteers]. [2007]
Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials. [2022]
Adverse non-drug-related complaints by healthy volunteers in Phase I studies compared to the healthy general population. [2019]
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