Inflammatory DiseasePhase 1NCT05857215
A First-in-Human Study of Single and Multiple Doses of Amilo-5MER in Healthy Subjects
A Phase 1 study testing amilo-5MER in people with Inflammatory Disease, run by Galmed Pharmaceuticals Ltd at 1 site in United Kingdom.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Disease
- What is being tested?
- amilo-5MER
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Mar 2021to 1 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
- Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min (Parts 1 and 2) or <60 mL/min (Part 3) using the Cockcroft-Gault equation at screening.
- History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator.
- Clinically significant abnormalities on electrocardiogram (ECG) (e.g. prolonged QTc, prolonged PR interval).
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever was allowed unless it was active.
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood.
- Had received blood or plasma derivatives in the 3 months preceding dosing.
- Adherence (for whatever reason) to an abnormal diet during the 4 weeks prior to the study, or subjects with recent significant change in body weight.
- Subjects who were taking, or had taken, any prescribed or over-the-counter drug (other than up to 2 g of paracetamol per day until 24 h prior to dosing and hormone replacement therapy [HRT]) or herbal remedies or dietary supplements (including bran) in the 14 days before IMP administration.
- Subjects with tattoos or scars on the abdomen which could have interfered with injection site assessments, as determined by the investigator at screening.
- Failure to satisfy the investigator of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences, Mere Way, Ruddington, Nottingham, NG11 6JS, UK
Nottingham, NG11 6JS
About this study
Official title: A Phase 1, Double-blind, Single and Multiple-Dose Study of Safety, Tolerability and Pharmacokinetics of Amilo-5MER in Healthy Volunteers
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)
Read the detailed description
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).
The study aim is to assess and characterize the safety and tolerability of single and multiple doses of amilo-5MER in healthy young adult subjects and single doses in healthy elderly subjects.
- Conditions
- Inflammatory Disease
- Being tested
- amilo-5MER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amilo-5MERDrug
Also called Synthetic peptide consisting of 5 amino acids
amilo-5MER is a 5 amino acid synthetic peptide MTADV (Methionine, Threonine, Alanine, Aspartic acid, Valine).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: amilo-5MER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Secondary outcomes (4)
PK- Area under the concentration-time curve (AUC)
Investigate the plasma Area under the concentration-time curve (AUC) of single and multiple doses of amilo-5MER
Measured: 10 days
PK- Time of maximum observed concentration (Tmax)
Investigate the plasma Time of maximum observed concentration (Tmax) of single and multiple doses of amilo-5MER
Measured: 10 days
PK- Maximum observed concentration (Cmax)
Investigate the plasma Maximum observed concentration (Cmax) of single and multiple doses of amilo-5MER
Measured: 10 days
PK- Total body clearance (CL/F)
Investigate the Total body clearance (CL/F) of single and multiple doses of amilo-5MER
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start5 Mar 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galmed Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- John Posner, PhD, FRCP, Study director, Pharmaceutical medicine consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857215
- Sponsor's protocol ID
- Amilo-5MER-002
- Status last verified
- Apr 2023
- First submitted
- 25 Apr 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected for exploration only.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Single and Multiple-Dose Study of Safety, Tolerability and Pharmacokinetics of Amilo-5MER in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05857215
- Acronym / sponsor ID
- Amilo-5MER-002
- Conditions
- Inflammatory Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Galmed Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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).
The study aim is to assess and characterize the safety and tolerability of single and multiple doses of amilo-5MER in healthy young adult subjects and single doses in healthy elderly subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| A- amilo-5MER solution for subcutaneous administration or matching placebo- 10 mg | Experimental | Drug: amilo-5MERAmilo-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 mg | Experimental | Drug: amilo-5MERAmilo-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 mg | Experimental | Drug: amilo-5MERAmilo-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 mg | Experimental | Drug: amilo-5MERAmilo-5MER solution for subcutaneous administration or matching placebo at a dose of 180 mg |
| E- amilo-5MER solution for subcutaneous administration or matching placebo- 360mg | Experimental | Drug: amilo-5MERAmilo-5MER solution for subcutaneous administration or matching placebo at a dose of 360 mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amilo-5MERAlso: Synthetic peptide consisting of 5 amino acidsamilo-5MER is a 5 amino acid synthetic peptide MTADV (Methionine, Threonine, Alanine, Aspartic acid, Valine). | Drug | 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 |
Primary outcome
Safety and tolerability of amilo-5ER
Time frame: 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.
4 secondary outcomes
PK- Area under the concentration-time curve (AUC)
Time frame: 10 days
PK- Time of maximum observed concentration (Tmax)
Time frame: 10 days
PK- Maximum observed concentration (Cmax)
Time frame: 10 days
PK- Total body clearance (CL/F)
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No. Data collected for exploration only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Posner, PhD, FRCP study director
Pharmaceutical medicine consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing amilo-5MER in people with Inflammatory Disease, run by Galmed Pharmaceuticals Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of amilo-5ER (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.