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amilo-5MER

Phase 1

Inflammatory Disease | Small molecule | Immunology |Eocene Ltd. Ordinary Shares|Trials Updated: May 12, 2023

amilo-5MER development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2023

amilo-5MER target and mechanism

ModalitySmall molecule

Also known as Synthetic peptide consisting of 5 amino acids

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment55

FDA Designations

No designations recorded

amilo-5MER clinical trials

amilo-5MER · 1 trial · 1 indication

Phase 1 1
NCT05857215A First-in-Human Study of Single and Multiple Doses of Amilo-5MER in Healthy SubjectsInflammatory Disease
COMPLETED55 Analytics
PHASE1COMPLETED
A First-in-Human Study of Single and Multiple Doses of Amilo-5MER in Healthy Subjects
Inflammatory DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of amilo-5ER
10 days

Assess and characterize the number of participants with clinically significant changes in safety assessments, including adverse events, physical examination findings, vital signs, clinical laboratory assessments, and urinalysis.

Secondary Endpoints

PK- Area under the concentration-time curve (AUC)
10 days
PK- Time of maximum observed concentration (Tmax)
10 days
PK- Maximum observed concentration (Cmax)
10 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A- amilo-5MER solution for subcutaneous administration or matching placebo- 10 mgEXPERIMENTALAmilo-5MER solution for subcutaneous administration or matching placebo at a dose of 10 mg
B- amilo-5MER solution for subcutaneous administration or matching placebo- 30 mgEXPERIMENTALAmilo-5MER solution for subcutaneous administration or matching placebo at a dose of 30 mg
C- amilo-5MER solution for subcutaneous administration or matching placebo- 90 mgEXPERIMENTALAmilo-5MER solution for subcutaneous administration or matching placebo at a dose of 90 mg
D- amilo-5MER solution for subcutaneous administration or matching placebo- 180 mgEXPERIMENTALAmilo-5MER solution for subcutaneous administration or matching placebo at a dose of 180 mg
E- amilo-5MER solution for subcutaneous administration or matching placebo- 360mgEXPERIMENTALAmilo-5MER solution for subcutaneous administration or matching placebo at a dose of 360 mg

Interventions

NameTypeDescription
amilo-5MERDRUGamilo-5MER is a 5 amino acid synthetic peptide MTADV (Methionine, Threonine, Alanine, Aspartic acid, Valine).
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy males (all parts) or healthy females (Part 3 only). 2. Aged 18 to 45 years (Parts 1 and 2) or aged 65 to 80 years (Part 3) inclusive at the time of signing informed consent. 3. Body mass index (BMI) of 19.0 to 31.0 kg/m2, with a body weight \<95 kg, as measured at scr...

Countries:United Kingdom
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Frequently asked questions about amilo-5MER

What is amilo-5MER?

Amilo-5MER is an investigational small molecule being developed by Eocene Ltd. Ordinary Shares (ticker EOCN) for inflammatory disease. It is in Phase 1 clinical development and has been studied in a first-in-human trial in healthy volunteers. It is not approved for any indication.

What is amilo-5MER used for?

Amilo-5MER is being developed for inflammatory disease, an immunology indication. Its only clinical study to date was a first-in-human trial in healthy subjects, so it has not been evaluated for efficacy in patients and is not approved for any use.

Who makes amilo-5MER?

Amilo-5MER is developed by Eocene Ltd. Ordinary Shares, which trades under the ticker EOCN. The company is the sponsor of the drug's clinical program in inflammatory disease.

What phase is amilo-5MER in?

Amilo-5MER is in Phase 1 development. Its single recorded trial, a first-in-human study of single and multiple doses in healthy subjects, has been completed. The drug remains investigational and has not been approved by the FDA or any other regulator.

What clinical trials is amilo-5MER in?

Amilo-5MER has been studied in one clinical trial, NCT05857215, titled A First-in-Human Study of Single and Multiple Doses of Amilo-5MER in Healthy Subjects. The Phase 1 trial enrolled 55 participants in the United Kingdom, was randomized, double-blind, and controlled, and is now completed.