AMG 691 for Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how a new treatment, AMG 691, behaves in the body and assesses its safety for healthy Chinese and Japanese individuals. Participants will receive varying doses of AMG 691 to observe their body's reactions. It suits healthy individuals of Chinese or Japanese ancestry interested in contributing to medical research. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that AMG 691 is likely to be safe for humans?
Research shows that AMG 691 is being tested for safety and tolerance in healthy individuals. Although complete safety information is not yet available, early studies have closely monitored participants to ensure their well-being. These studies have examined the effects of a single dose in healthy individuals. This careful monitoring helps identify any side effects early and ensures the treatment is well-tolerated. While detailed information remains limited, these early studies confirm that AMG 691 can be safely administered in controlled settings.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about AMG 691 because it offers a new approach by being administered subcutaneously, potentially improving convenience and patient compliance compared to traditional oral or intravenous treatments. This investigational drug is being tested at different dose levels, which could reveal optimal dosing that maximizes effectiveness while minimizing side effects. Additionally, AMG 691 is being studied in diverse populations, including Chinese and Japanese participants, which may provide valuable insights into how different groups respond to the treatment.
What evidence suggests that AMG 691 could be effective?
Research on AMG 691 has primarily focused on its safety and pharmacokinetics. Limited information exists on its efficacy for specific conditions. Studies have mostly involved healthy volunteers to ensure the treatment is safe and well-tolerated. In this trial, different cohorts will receive varying doses of AMG 691 to assess its safety profile. Researchers are exploring the treatment for potential use in conditions like asthma, but detailed results on its effectiveness for asthma are not yet available. AMG 691 targets specific parts of the immune system, which might aid in treating inflammatory conditions. Currently, the main goal is to ensure its safety for human use.13567
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for healthy Chinese and Japanese adults. People with current illnesses, especially lung diseases or infections, or those taking certain medications likely cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of AMG 691 administered subcutaneously
Follow-up
Participants are monitored for safety, tolerability, and pharmacokinetics after receiving AMG 691
What Are the Treatments Tested in This Trial?
Interventions
- AMG 691
Trial Overview
The study is testing a new drug called AMG 691 to see how it moves through the body, its safety, and if it causes any immune reactions in healthy volunteers. It is an early-phase (Phase 1) clinical trial.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Japanese participants will receive AMG 691 at the Level B dose administered SC
Chinese participants will receive AMG 691 at the Level B dose administered SC
Japanese participants will receive AMG 691 at the Level A dose administered SC
Chinese participants will receive AMG 691 at the Level A dose administered subcutaneously (SC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Citations
A Phase 1 Trial of AMG 691 in Healthy Chinese and ...
The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants.
A Phase 1 Trial of AMG 691 in Healthy Chinese and ...
The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese ...
A Phase 1, Randomized, Double-blind, Placebo-controlled ...
The main objective of this study is to assess the safety and tolerability of AMG 691 as single doses (healthy participants only) and multiple ...
AMG 691 for Asthma · Info for Participants
The main objective of this study is to assess the safety and tolerability of AMG 691 as single doses (healthy participants only) and multiple doses in healthy .
5.
trial.medpath.com
trial.medpath.com/clinical-trial/7667adbf8a89933e/nct06637371-amg-691-safety-tolerability-pharmacokinetics-pharmacodynamics-asthmaA Phase 1, Randomized, Double-blind,... | Clinical Trial
The main objective of this study is to assess the safety and tolerability of AMG 691 as single doses (healthy participants only)
AMGEN - A Phase 1, Randomized, Double-blind, Placebo ...
The main objective of this study is to assess the safety and tolerability of AMG 691 as single doses (healthy participants only)
Trial | NCT06637371
The main objective of this study is to assess the safety and tolerability of AMG 691 as single doses (healthy participants only) and multiple doses in healthy ...
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