Phase 1 Study of AMG 691 in Healthy Participants & Asthma Participants

• Research type

  Research Study

• Full title

  A Phase 1, Randomized, Double-blind, Placebo-controlled, Integrated Single Ascending Dose, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma

• IRAS ID

  1011139

• Contact name

  Matthew Rodaway

• Contact email

  UKRegClinical@amgen,com

• Sponsor organisation

  Amgen Inc

• Eudract number

  2025-520503-27

• Clinicaltrials.gov Identifier

  NCT06637371

• Research summary

  This is a first-in-human study to understand how safe AMG 691 is for someone to take and how someone feels while taking it, how AMG 691 moves throughout the body and what the body does to it, and how AMG 691 works when given as a single dose to healthy participants and as multiple doses in healthy participants and participants with mild-to-moderate asthma. AMG 691 may inhibit activation of immune cells resulting in decreased inflammation and improvement of asthma symptoms (coughing, wheezing, chest tightness, and shortness of breath) and lung function among participants with asthma.

  Participants will be given AMG 691 or placebo (looks like AMG 691 but does not contain the medication) as part of this study.
  Neither the participants nor the study doctor can choose the study treatment that the participants will get. Participants agree to be put into a treatment group by chance (“randomised”).

  The study has 3 parts:
  •Part A includes up to 7 groups with around 56 healthy participants. Each group of participants will receive a single dose of AMG 691 (or placebo) at a higher dose level compared to the previous group.
  •Part B includes up to 4 groups with around 32 healthy participants. Each group of participants will receive at least 2 doses of AMG 691 (or placebo) at a higher dose level compared to the previous group. Part B is started any time after the third group in Part A.
  •Part C includes up to 2 groups with around 36 participants with mild-to-moderate asthma. Each group will receive at least 2 doses of AMG 691 (or placebo). Part C will start any time after the second group in Part B.

  In Parts A and B, increasing doses of AMG 691 (or placebo) will only be given if the prior dose is shown to be safe and reasonably well tolerated. Parts B and C will begin once the doses used in Parts A and B are shown to be safe and reasonably well tolerated by healthy participants.

  The UK will only participate in Part C of this study.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  25/EE/0056

• Date of REC Opinion

  13 May 2025

• REC opinion

  Further Information Favourable Opinion