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

Inflammatory Disease Clinical Trial

Official title:

A Phase 1, Double-blind, Single and Multiple-Dose Study of Safety, Tolerability and Pharmacokinetics of Amilo-5MER in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05857215
• Other study ID #: Amilo-5MER-002
• Status: Completed
• Phase: Phase 1
• Start date: March 5, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: April 2023
• Source: Galmed Pharmaceuticals Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 screening.

4. Willing and able to communicate and participate in the whole study.

5. Provided a written informed consent.

6. Agreed to adhere to the contraception requirements

Exclusion Criteria:

1. Subjects who had received any IMP in a clinical research study within the 90 days prior to Day 1.

2. Subjects who were, or were immediate family members of, a study site or sponsor employee.

3. 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.

4. 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.

5. History of any drug or alcohol abuse in the past 2 years.

6. 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).

7. A confirmed positive alcohol breath test at screening or admission.

8. 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.

9. Current users of e-cigarettes and nicotine replacement products and those who had used these products within the last 6 months.

10. 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).

11. Male subjects who had pregnant or lactating partners.

12. Subjects who did not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening.

13. 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]).

14. 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.

15. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.

16. 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.

17. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator.

18. Clinically significant abnormalities on electrocardiogram (ECG) (e.g. prolonged QTc, prolonged PR interval).

19. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.

20. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever was allowed unless it was active.

21. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood.

22. Had received blood or plasma derivatives in the 3 months preceding dosing.

23. 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.

24. 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.

25. Subjects with tattoos or scars on the abdomen which could have interfered with injection site assessments, as determined by the investigator at screening.

26. Failure to satisfy the investigator of fitness to participate for any other reason.

Related Conditions & MeSH terms

• Inflammatory Disease

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences, Mere Way, Ruddington, Nottingham, NG11 6JS, UK	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Galmed Pharmaceuticals Ltd	Quotient Sciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	10 days
Secondary	PK- Time of maximum observed concentration (Tmax)	Investigate the plasma Time of maximum observed concentration (Tmax) of single and multiple doses of amilo-5MER	10 days
Secondary	PK- Maximum observed concentration (Cmax)	Investigate the plasma Maximum observed concentration (Cmax) of single and multiple doses of amilo-5MER	10 days
Secondary	PK- Total body clearance (CL/F)	Investigate the Total body clearance (CL/F) of single and multiple doses of amilo-5MER	10 days