A study to evaluate the PK of IPP-201101 in healthy volunteers
Research type
Research Study
Full title
A Phase 1, Open-label, Single Dose Pharmacokinetic Study of IPP-201101 after Subcutaneous and Intravenous Administration in Healthy Male Volunteers.
IRAS ID
305901
Contact name
Annelize Koch
Contact email
Sponsor organisation
ImmuPharma S.A/PLC
Eudract number
2021-004976-33
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
Research Summary
The purpose of this study is to investigate the study drug IPP-201101.\n\nThe objectives of this study are:\n- To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of IPP-201101 when it is administered as a subcutaneous injection (injection into the tissue layer between the skin and muscle) at different dose strengths on one occasion.\n\n- To investigate the concentration of IPP-201101 in the blood and urine, how this changes over a period of time and whether there are differences in the concentration profile between different dose strengths. \n\n- To evaluate and compare the bioavailability (the degree and rate at which a substance (such as a drug) is absorbed into the body or is made available at the site of its’ desired effect) of IPP-201101 when it is administered as a subcutaneous injection in comparison to administration as an intravenous injection (an injection directly into a vein).\n\nThe study will consist of up to 3 groups of 8 participants; each group investigating a different dose strength of IPP-201101. In this study, all participants will be given a single dose of IPP-201101 in the form of a subcutaneous injection on one occasion. One of the groups will complete a second treatment period whereby IPP-201101 will be given in the form of an intravenous injection. Group 3 of the study is considered optional and will only be conducted if the data from Group 1 & 2 indicates that is it necessary to do so.\n\nBlood and urine samples will be taken throughout the study in order to measure the concentration profile of IPP-201101. We will compare the results from each of the groups to determine if there are any significant differences in the safety or concentration profile of IPP-201101 between the different dose strengths.
Summary of results
The purpose of this study was to investigate the study drug IPP-201101. The main objectives of this study were as follows:
- To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of IPP-201101 when it was administered as a subcutaneous injection (injection into the tissue layer between the skin and muscle) at different dose strengths on one occasion.
- To investigate the concentration of IPP-201101 in the blood and urine, how this changed over a period of time and to determine whether there were differences in the concentration profile between different dose strengths.
- To evaluate and compare the bioavailability (the degree and rate at which a substance (such as a drug) is absorbed into the body or is made available at the site of its' desired effect) of IPP-201101 when it was administered as a subcutaneous injection in comparison to administration as an intravenous injection (an injection directly into a vein).
As well as evaluating the above, the study also evaluated as exploratory objectives, the immunogenicity (immune system response) to IPP-201101 in the body and measured the metabolite profile of IPP-201101 in both blood and urine (if required). Metabolites are by-products which are produced when a drug is broken down in the body.
The study consisted of up to 3 groups of 8 participants; each group investigating a different dose strength of IPP-201101. However, only 16 participants were enrolled as it was determined that Group 3 of the study was not required. In the study, all participants were given IPP-201101 in the form of a subcutaneous injection. Group 2 also completed a second treatment period whereby IPP-201101 was given in the form of an intravenous injection as described above.
Blood and urine samples were taken at set time points throughout the study in order to measure the concentration profile of IPP-201101. The results from each of the groups have been compared to determine if there are any significant differences in the safety profile of IPP-201101, the concentration of IPP-201101 in the blood and urine, how this changed over time and whether there were any differences in these factors between different dose strengths and in comparison to when the drug was administered as a subcutaneous injection versus as an intravenous injection.
The purpose of the data generated in this study was to provide further information and guidance to support the study sponsor in development of the study drug.
With respect to the safety objectives of the study, it was determined that the IPP-20101 was considered to be safe and well tolerated at all dose levels evaluated (200 µg & and 800 µg respectively) and via both routes of administration. All adverse events (side effects) which were reported were mild to moderate in severity and resolved before the study completed, without any treatment. There were no effects reported which were related to reactions at the site of the injections and of the 3 subjects who reported side effects, 2 reported events were deemed as not related to the study drug and one reported event was considered related following intravenous administration that completely resolved within 5 hours of administration with no treatment. There were no other relevant safety findings in the study.
With respect to the other objectives of the study, (namely related to the levels of the study drug in the blood and urine), the following outcomes were reported:
- The levels of IPP-201101 in the blood following subcutaneous administration were very low for both dose strengths with the highest values observed close to the lowest values set for analysis.
- It was noted that the levels in the blood did increase with dose strength; however, it was not possible to determine all of the parameters for analysis from the samples.
- When compared to the intravenous administration, the subcutaneous administration showed a significantly lower bioavailability (the degree and rate at which a substance (such as a drug) is absorbed into the body or is made available at the site of its' desired effect).
- In conclusion, it was noted that any interpretations based off this data should be viewed with caution as the overall data was considered to be highly variable, given the small number of participants per group.
In summary, the data gathered during the study was considered sufficient to meet the objectives of the study and warrant further clinical trials and investigations of the study drug.
REC name
Wales REC 1
REC reference
21/WA/0327
Date of REC Opinion
8 Oct 2021
REC opinion
Favourable Opinion