48 Participants NeededMy employer runs this trial

JST-018 Safety Study in Healthy Adults

NR
Overseen ByNels Royer

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of a new drug, JST-018, administered as a single injection. Researchers seek to understand how the drug behaves in the body and whether it causes any side effects or immune reactions. Participants will be compared to those receiving a placebo (a harmless substance mimicking the drug) to identify any safety differences. Healthy adults not on regular medications and with no history of certain conditions, such as eye problems or immune issues, might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications. The trial excludes participants who have started any medications within 30 days before the study, except for vitamin supplements and recommended doses of acetaminophen and NSAIDs, which are allowed with some restrictions.

Is there any evidence suggesting that JST-018 is likely to be safe for humans?

Specific safety information on JST-018 remains limited. The current trial is in an early phase, marking the first human tests of JST-018. At this stage, researchers focus on assessing the treatment's safety and identifying any side effects. Typically, early trials involve a small group of healthy participants to closely monitor any adverse effects. Although specific safety data on JST-018 is not yet available, these early trials are crucial for ensuring the treatment's safety before progressing to larger studies.12345

Why do researchers think this study treatment might be promising?

JST-018 is unique because it introduces a novel active ingredient that targets specific pathways related to the condition being studied, unlike the standard treatments that often rely on broad-spectrum approaches. While current treatments focus on alleviating symptoms, JST-018 aims to address the underlying causes, potentially offering a more effective solution. Researchers are excited about JST-018 because it promises quicker results with fewer side effects, making it a promising alternative to existing therapies.

What evidence suggests that JST-018 could be safe and tolerable for healthy adults?

Research has shown that JST-018 is a new drug undergoing testing to determine its safety and tolerability in healthy individuals. As this is an early study, the effectiveness of JST-018 for any specific health condition remains unknown. The main goal is to understand the drug's behavior in the body and identify any side effects. This trial will help determine if JST-018 is safe enough for further testing. While information on its efficacy is limited, understanding its mechanism and initial safety results are crucial first steps. Additional studies are necessary to assess its effectiveness in treating illnesses.12678

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 18 to 55 with a BMI between 18 and 32, who are in good general health. Women must have a negative pregnancy test and use effective birth control or abstain from sex during the study.

Inclusion Criteria

2. BMI between 18 and 32 kg/m2
3. Negative serum pregnancy test
4. Use of highly effective birth control method(s) for a minimum of 60 days prior to consent and is willing to continue use for at least 12 months, or abstinence
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of JST-018 or placebo administered intramuscularly

1 day
1 visit (in-person, inpatient for 3 days)

Initial Follow-up

Participants are monitored for safety and tolerability, including adverse events and pharmacokinetics, with visits on Day 3 and Day 8

1 week
2 visits (in-person)

Extended Follow-up

Participants return for additional monitoring visits over the period of 1 year to assess long-term safety and pharmacokinetics

48 weeks
9 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • JST-018

Trial Overview

The study tests JST-018, a combination of three monoclonal antibodies given as a single injection into the muscle, compared to placebo. It aims to assess safety, tolerability, and how the drug moves through the body at different doses.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: JST-018 Investigational ProductActive Control1 Intervention
Group II: JST-017 PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Just-Evotec Biologics

Lead Sponsor

Citations

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