A First-in-Human Study of Single and Multiple Doses of Amilo-5MER in Healthy Subjects

NCT05857215 | Completed Phase 1

• 1 other identifier: Amilo-5MER-002
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This is a three-part, single Centre, double-blind, randomized, placebo-controlled first-in-human study of single ascending doses (SADs, Part 1) and multiple doses (Part 2) of amilo-5MER in healthy young adult male subjects and a single dose cohort in healthy elderly male and female subjects (Part 3)

Conditions

Inflammatory Disease

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of amilo-5ER

  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.

  10 days

Secondary Outcomes (4)

• 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

• PK- Total body clearance (CL/F)

  10 days

Study Arms (5)

A- amilo-5MER solution for subcutaneous administration or matching placebo- 10 mg

EXPERIMENTAL

Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 10 mg

Drug: amilo-5MER

B- amilo-5MER solution for subcutaneous administration or matching placebo- 30 mg

EXPERIMENTAL

Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 30 mg

Drug: amilo-5MER

C- amilo-5MER solution for subcutaneous administration or matching placebo- 90 mg

EXPERIMENTAL

Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 90 mg

Drug: amilo-5MER

D- amilo-5MER solution for subcutaneous administration or matching placebo- 180 mg

EXPERIMENTAL

Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 180 mg

Drug: amilo-5MER

E- amilo-5MER solution for subcutaneous administration or matching placebo- 360mg

EXPERIMENTAL

Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 360 mg

Drug: amilo-5MER

Interventions

amilo-5MER DRUG

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

Also known as: Synthetic peptide consisting of 5 amino acids

A- amilo-5MER solution for subcutaneous administration or matching placebo- 10 mg; B- amilo-5MER solution for subcutaneous administration or matching placebo- 30 mg; C- amilo-5MER solution for subcutaneous administration or matching placebo- 90 mg; D- amilo-5MER solution for subcutaneous administration or matching placebo- 180 mg; E- amilo-5MER solution for subcutaneous administration or matching placebo- 360mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males (all parts) or healthy females (Part 3 only).
• 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.
• Body mass index (BMI) of 19.0 to 31.0 kg/m2, with a body weight \<95 kg, as measured at screening.
• Willing and able to communicate and participate in the whole study.
• Provided a written informed consent.
• Agreed to adhere to the contraception requirements

You may not qualify if:

• Subjects who had received any IMP in a clinical research study within the 90 days prior to Day 1.
• Subjects who were, or were immediate family members of, a study site or sponsor employee.
• Subjects who had previously been administered IMP in this study. Subjects who took part in Part 1 were not permitted to take part in Part 2.
• Evidence of recent SARS-CoV-2 symptomatic infection within the last 3 months. Subjects who had asymptomatic, incidental, positive polymerase chain reaction (PCR) findings could have been included if tested more than 30 days prior to screening and test negative at screening.
• History of any drug or alcohol abuse in the past 2 years.
• Regular alcohol consumption in males \>21 units per week and females (Part 3 only) \>14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type).
• A confirmed positive alcohol breath test at screening or admission.
• Current smokers and those who had smoked within the last 6 months. A confirmed breath carbon monoxide (CO) reading of greater than 10 ppm at screening or admission.
• Current users of e-cigarettes and nicotine replacement products and those who had used these products within the last 6 months.
• Females of childbearing potential including those who were pregnant or lactating (all female subjects must have had a negative highly sensitive urine and serum pregnancy test). A woman was considered of childbearing potential unless she was permanently sterile (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or was postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle stimulating hormone \[FSH\] concentration ≥30 IU/L) at screening and admission visit (Part 3 only).
• Male subjects who had pregnant or lactating partners.
• Subjects who did not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening.
• Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1 of protocol \[Appendix 16.1.1.1\]).
• Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1 of protocol \[Appendix 16.1.1.1\]) at screening or admission.
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.

Sponsors & Collaborators

• Galmed Pharmaceuticals Ltd: lead
• Quotient Sciences: collaborator

Study Sites (1)

Quotient Sciences, Mere Way, Ruddington, Nottingham, NG11 6JS, UK

Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• John Posner, PhD, FRCP

  Pharmaceutical medicine consultant

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects were assigned to a treatment using a computer-generated randomization schedule.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 of the study was a double-blind, randomised, placebo-controlled assessment of single subcutaneous (SC) ascending doses of amilo-5MER in healthy young adult male subjects. Subjects were enrolled sequentially into 1 of up to 5 cohorts, each containing 8 subjects

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 12, 2023
• Study Start: March 5, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: May 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)