28 Participants NeededMy employer runs this trial

AMG 691 for Healthy Volunteers

AC
Overseen ByAmgen Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

M

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

Participants of reproductive potential must agree to follow protocol-specified contraception requirements
Willing to maintain usual diet and physical activity regimen throughout study participation
First-generation Chinese ancestry (born in China, Hong Kong, Taiwan, or Macau with 2 Chinese parents and 4 Chinese grandparents) or first-generation Japanese ancestry (born in Japan with 2 Japanese parents and 4 Japanese grandparents)
See 4 more

Exclusion Criteria

Positive or indeterminate QuantiFERON-TB Gold test
History of alcohol abuse or excessive alcohol consumption
I have not received any live vaccines in the past 12 weeks.
See 20 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 AMG 691 administered subcutaneously

1 day

Follow-up

Participants are monitored for safety, tolerability, and pharmacokinetics after receiving AMG 691

4 weeks

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?

4

Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment1 Intervention
Group II: Cohort 3Experimental Treatment1 Intervention
Group III: Cohort 2Experimental Treatment1 Intervention
Group IV: Cohort 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

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 .

A 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 ...