Phase 1 study (QSC302234)
Research type
Research Study
Full title
An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]EIK1001 Administered Intravenously in Healthy Male Subjects
IRAS ID
1010478
Contact name
Harry Raftopoulos M.D.
Contact email
Sponsor organisation
Eikon Therapeutics, Inc.
ISRCTN Number
ISRCTN12459436
Research summary
The Sponsor is developing the test medicine, EIK1001, as a potential treatment for cancer using the body’s immune system. Similar anticancer treatments aim to block checkpoints that regulate the immune system leading to the immune system attacking tumours in the body. However these current therapies do not work for everyone and more than half of patients eventually experience cancer progression whilst on treatment.
The test medicine helps cells and proteins associated with the immune system trigger a more effective response against tumours and can be used alongside current anticancer treatments. This kind of treatment can lead to the immune system remembering how to target the cancer cells and provide a long-lasting treatment.
The test medicine has already been given to patients with cancer but no healthy volunteers have received it before.
In this study we’ll give healthy volunteers a single dose of test medicine to find out how the body breaks down and gets rid of the test medicine. The test medicine will be ‘radiolabelled’ - it will contain a small amount of radioactivity - so that we can track it in the body.
In this study in healthy volunteers, we aim to answer these questions.
*What are the blood levels of the test medicine and how quickly does the body get rid of it?
*How does the body break down and what is it broken down into?
*Does the test medicine cause any important side effects?
This study will take place at 1 site in Nottingham.
We plan to enrol 8 healthy men aged 30-65 years.
Volunteers will receive a single dose of radiolabelled test medicine by injection into a vein. They’ll stay in the clinic for up to 10 nights, attend 1 outpatient visit, and take up to 6 weeks to finish the study.
We’ll collect blood and urine samples to do safety tests. Over a period of at least 9 days we’ll take many blood samples and volunteers will collect all their urine and faeces so that we can measure the amount of test medicine and its breakdown products.REC name
London - Hampstead Research Ethics Committee
REC reference
24/LO/0746
Date of REC Opinion
4 Feb 2025
REC opinion
Further Information Favourable Opinion