Systemic lupus erythematosus (SLE) Musculoskeletal Diseases Systemic lupus erythematosus
Conditions
Interventions
The study is an open-label bioavailability study evaluating the safety, tolerability and concentration in the blood and urine of IPP-201101 when it is administered at different dose strengths and via
Cohort 1 will investigate a low dose level while Cohort 2 will investigate a higher dose level of IPP-201101. Optional Cohort 3 may investigate a third intermediate dose level in order to further char
a decision on whether to proceed with optional Cohort 3 will be taken following a review of all available PK data from Cohort 1 and 2. The absolute bioavailability of IPP-201101 will also be investiga
Sponsors
ImmuPharma S.A
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male volunteer, between 18 and 55 years of age, inclusive 2. Male volunteer (and partner of childbearing potential) willing to use a highly effective method of contraception or two effective methods of contraception, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the volunteer) from first dose until 3 months after last dose of IMP. 3. Volunteer with a body mass index (BMI) of 18-32 kg/m². BMI = body weight (kg) / [height (m)]² 4. No clinically significant history of previous allergy/sensitivity to IPP 201101 or any of the excipients contained within the IMP 5. No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 28 days before the first dose administration of the IMP 6. Volunteer with a negative urinary drugs of abuse (DOA) toxicology screen (including alcohol) test results, determined within 28 days before the first dose administration of the IMP (N.B. A positive test result may be repeated at the Investigator’s discretion) 7. Volunteer with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) test results at Screening 8. No clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 28 days before the first dose of IMP including a PR interval > 220ms or QT interval corrected using Fredericia’s formula (QTcF) >450 ms 9. No clinically significant abnormalities in vital signs (blood pressure/heart rate, oral temperature) determined within 28 days before the first dose of IMP 10. Volunteer must be available to complete the study (including all follow-up visits) 11. Volunteer must satisfy an Investigator about his/her fitness to participate in the study 12. Volunteer must provide written informed consent to participate in the study 13. Participants with a negative coronavirus disease 2019 (COVID-19) test on admission (if required)
Exclusion criteria
Exclusion criteria: 1. Evidence of clinically significant renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction 2. Individual or family history of pre-existing autoimmune or antibody-mediated diseases 3. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 28 days or 5 half-lives (whichever is longer) prior to the first dose of IMP 4. Volunteers who have received any prophylactic vaccine (including COVID-19 vaccine) or immunisation within the last 28 days or use of corticosteroids or immunosuppressive drugs within 28 days of IMP administration 5. A clinically significant history of drug or alcohol abuse (defined as the consumption of more than 14 units of alcohol a week for male volunteers) within the past 2 years 6. Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function) 7. Participation in a New Chemical Entity (NCE) clinical study within the previous 3 months or five half-lives whichever is the longest, or a marketed drug clinical study within the 30 days or five half-lives whichever is the longest, before the first dose of IMP. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study). 8. Donation of 450 millilitres (ml) or more blood within the 3 months before the first dose of IMP 9. Vegans, vegetarians or other dietary restrictions (e.g., restrictions for medical, religious or cultural reasons, etc) 10. Users of nicotine products i.e., current smokers or ex-smokers who have smoked within 3 months prior to first dose administration with the study medication or users of cigarette replacements (i.e., e-cigarettes, nicotine patches or gums) 11. Volunteers who do not have suitable veins for multiple venepunctures/cannulation 12. Volunteers who have any clinical condition or prior therapy which, in the opinion of the Investigator, could jeopardize the safety or rights of a volunteer participating in the trial or would render them unable to comply with the protocol 13. Volunteers who are study site employees, or immediate family members of a study site or sponsor employee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters derived from analysis of plasma and urine concentrations of IPP-201101. The following PK parameters will be derived from plasma IPP-201101 concentrations: 1. Cmax: observed maximum concentration 2. tmax: time of occurrence of Cmax 3. ?z: apparent first-order terminal elimination rate constant 4. t1/2: apparent terminal elimination half-life 5. AUC0 t: area under the concentration time curve (AUC) from time of dosing to last measurable concentration 6. AUC0 inf: AUC extrapolated to infinity 7. AUC%extrap: extrapolated area under the curve from tlast to infinity, expressed as a percentage 8. Cl/F: apparent total body clearance 9. Vz/F: apparent volume of distribution Plasma samples for PK evaluation of IPP-20101 will be taken at the following timepoints: Day 1: pre-dose, 5, 10, 15, 20, 25, 30, 40, 50 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 h post-Day 1 dose in each treatment period. The following PK parameters will be derived from urine IPP-201101 concentrations: 1. Ae: cumulative amount of drug excreted in urine 2. Ae%: percentage of dose excreted in urine over each collection interval 3. CLR: renal clearance Urine samples for PK evaluation of IPP-20101 will be taken at the following timepoints: Day 1: pre-dose 0-8 h, 8 12 h, and 12-24 h post-Day 1 dose in each treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints defined as follows: 1. Adverse events (AEs) including serious AEs (SAEs) and treatment-emergent AEs (TEAEs) will be recorded from the point of informed consent up to the final post-study follow-up visit 2. Laboratory safety testing at Screening, Day -1, Day 2 of each treatment period (as applicable) and post-study follow-up visit on Days 5-8 3. Vital signs at Screening and Day 1 at pre-dose and 12 h post-dose, on Day 2 at 24 hours post-dose of each treatment period (as applicable) and at post-study follow-up visit on Day 5-8 4. 12-lead ECG at Screening and Day 1 at pre-dose and 12 h post-dose, on Day 2 at 24 hours post-dose of each treatment period (as applicable) and at post-study follow-up visit on Day 5-8 5. Injection site reaction examinations will be performed on Day 1 (1 h, 6 h and 12 h post-dose), Day 2 (24 h post-dose) of each treatment period (as applicable) and at post-study follow-up visit on Day 5-8 | — |
Countries
United Kingdom, Wales
Contacts
Public ContactTim Franklin
Outcome results
None listed