Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04921254
Status:
RECRUITING
Last Update Posted:
2022-11-21
First Post:
2021-04-24
Brief Title:
A Study to Assess the Safety Tolerability and Pharmacokinetics of BSG005
Sponsor:
Biosergen AS
Organization:
Biosergen AS
Study Overview
Official Title:
A Phase 1 Double-blinded Placebo-controlled Study to Assess the Safety Tolerability and Pharmacokinetics of BSG005 Following Single and Multiple Ascending Doses in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 1 double-blinded placebo-controlled study to assess the safety tolerability and pharmacokinetics of BSG005 following single and multiple ascending doses in healthy subjects The study will include a single ascending dose part and a multiple ascending dose part
Detailed Description:
The study will investigate the safety and tolerability of BSG005 in healthy subjects The study will also include pharmacokinetic investigations
There will be an ascending single dose part SAD with 6 subject in a study dose cohort of which 2 will be placebo and 4 will be on active drug This concept will be replicated in the multiple ascending dose MAD part
There is expected to be up to6 cohorts in SAD part with a starting dose calculated from the GLP NOAEL dose levels and from that increasing dose levels will be tested after a Safety Review Committee SRC has approved the escalation to next dose level The key parameters are infusion reactions kidney liver and potassium changes during and after administration of BSG005
Depending on the outcome of the SAD part the MAD part may include 4 or 5 dose levels administered daily over 7 days Key parameters are the same as in the SAD part but extended to cover monitoring over 14 days Pharmacokinetics at day 1 and day 7 will be investigated
Key evaluation is on safety and tolerability during and after 7 days of dosing and pharmacokinetic investigations and the steady state plasma levels
There will be an ascending single dose part SAD with 6 subject in a study dose cohort of which 2 will be placebo and 4 will be on active drug This concept will be replicated in the multiple ascending dose MAD part
There is expected to be up to6 cohorts in SAD part with a starting dose calculated from the GLP NOAEL dose levels and from that increasing dose levels will be tested after a Safety Review Committee SRC has approved the escalation to next dose level The key parameters are infusion reactions kidney liver and potassium changes during and after administration of BSG005
Depending on the outcome of the SAD part the MAD part may include 4 or 5 dose levels administered daily over 7 days Key parameters are the same as in the SAD part but extended to cover monitoring over 14 days Pharmacokinetics at day 1 and day 7 will be investigated
Key evaluation is on safety and tolerability during and after 7 days of dosing and pharmacokinetic investigations and the steady state plasma levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None