Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563115
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Safety Tolerability Pharmacokinetics and Pharmacodynamics of PEG-BHD1028
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blinded Placebo-Controlled Single and Multiple Ascending Dose Study in OverweightObese Subjects to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of PEG-BHD1028
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adiponectin has been known to play critical roles in various physio-regulatory processes and adiponectin deficiency may contribute to insulin resistance PEG-BHD1028 was developed as an agonist of adiponectin receptors
This first-in-human study evaluates the safety tolerability pharmacokinetics and pharmacodynamics of PEG-BHD1028 in healthy overweightobese subjects with insulin resistance
This first-in-human study evaluates the safety tolerability pharmacokinetics and pharmacodynamics of PEG-BHD1028 in healthy overweightobese subjects with insulin resistance
Detailed Description:
PEG-BHD1028 is a peptide agonist to adiponectin receptors AdipoR1 and R2 designed based on the active site of the hormone and receptor binding configurations Various scientific and clinical research revealed that adiponectin deficiency is positively associated with pathophysiological conditions including insulin resistance and inflammation Despite the beneficial effects of adiponectin the hormone could not be developed into a therapeutic agent because of the complications in controlling post-transcriptional modifications
This study investigates the safety and tolerability of PEG-BHD1028 after a single ascending dose SAD of a placebo 4 8 16 32 and 64 μgKg and multiple ascending doses MAD of a placebo 8 16 and 32 μgKg for 28 days following QD injection subcutaneously in the healthy obeseoverweight subjects The pharmacokinetics PK and pharmacodynamics PD are also evaluated following single and multiple doses and multiple doses respectively The changes in the inflammatory biomarkers are explored during the 28 days as a part of the MAD portion study
This study investigates the safety and tolerability of PEG-BHD1028 after a single ascending dose SAD of a placebo 4 8 16 32 and 64 μgKg and multiple ascending doses MAD of a placebo 8 16 and 32 μgKg for 28 days following QD injection subcutaneously in the healthy obeseoverweight subjects The pharmacokinetics PK and pharmacodynamics PD are also evaluated following single and multiple doses and multiple doses respectively The changes in the inflammatory biomarkers are explored during the 28 days as a part of the MAD portion study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None