What side effects are associated with this type of intervention?

In clinical trials involving intravenous or subcutaneous administration of drugs in healthy subjects, common side effects include local injection site reactions such as erythema, pain, or bruising. These reactions are usually mild. Other frequently reported adverse events include fatigue, hot flushes, and decreased appetite. Serious adverse effects are uncommon, but hypersensitivity reactions like rash, pruritus, and urticaria can occur. Neurocognitive symptoms and muscle toxicity are rare.

What prior FDA approvals exist?

Prior FDA approvals for treatments in healthy subjects often involve drugs being evaluated for safety, tolerability, and pharmacokinetics, similar to the study of LY3848575. Examples include GLP-1 agonists like liraglutide, which were tested in healthy volunteers to determine their pharmacokinetic profiles and safety before being approved for conditions such as type 2 diabetes and obesity. These initial studies are essential for ensuring the drug's safety and understanding its behavior in the body, paving the way for subsequent trials in patients with specific health conditions.

What other types of research exist?

Promising alternatives to LY3848575 include MYL-1401O, a trastuzumab biosimilar, which has demonstrated similar pharmacokinetics and safety profiles to EU-trastuzumab and US-trastuzumab without serious adverse events. Additionally, drugs like fremanezumab and erenumab, used for migraine prevention, have shown good safety and tolerability profiles in phase 3 studies. These alternatives have been well-tolerated in healthy subjects and could be considered for further evaluation.

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Monoclonal Antibodies

LY3848575 for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 142 days

Summary

This trial is testing a new drug called LY3848575 to see if it is safe and well-tolerated. The study includes healthy non-Japanese and first-generation Japanese participants. Researchers will check how fast the drug gets into the blood and how long it stays in the body.

Who is the study for?

This trial is for healthy adults who weigh at least 50 kg (110 lbs) for males, 40 kg (88 lbs) for females, and have a BMI of 18-30. Japanese participants must be first-generation with all parents and grandparents born in Japan. Participants can't join if they're in another study or were in one within the last 3 months.

What is being tested?

The study tests LY3848575 given by IV or under the skin to see how safe it is and how the body handles it. It compares this new drug to a placebo over roughly five months, including screening time before starting.

What are the potential side effects?

Since LY3848575 is being tested for safety, potential side effects are not yet known but will be monitored closely throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 142 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 142 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 142 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Secondary study objectives

PK: AUC of LY3848575 When Administered SC.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3848575 When Administered IV.

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3848575 SCExperimental Treatment1 Intervention

Multiple doses of LY3848575 administered subcutaneously (SC).

Group II: LY3848575 IVExperimental Treatment1 Intervention

Single ascending doses of LY3848575 administered intravenously (IV).

Group III: Placebo SCPlacebo Group1 Intervention

Placebo administered SC.

Group IV: Placebo IVPlacebo Group1 Intervention

Placebo administered IV.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3848575

2023

Completed Phase 1

~70

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The mechanisms of action for common treatments in healthy subjects, such as those studied in the LY3848575 trial, focus on understanding the drug's pharmacokinetics—how it is absorbed, distributed, metabolized, and excreted by the body. This is crucial for ensuring the drug's safety and tolerability, determining appropriate dosing, and identifying any potential side effects. Studying these mechanisms in healthy subjects provides a clear baseline, which is essential for developing safe and effective treatments for future patient populations.

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