NCT06563115

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of (PEG)-BHD1028

A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study in Overweight/Obese Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of (PEG)-BHD1028

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: EncuraGen, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 overweight/obese 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 μg/Kg and multiple ascending doses (MAD) of a placebo, 8, 16, and 32 μg/Kg for 28 days following Q.D. injection subcutaneously in the healthy obese/overweight 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.

Conditions

• Insulin Resistance

Interventions

Type	Name	Description
DRUG	(PEG)-BHD1028 Single Ascending Dose	4, 8, 16, 32, and 64 μg/Kg
DRUG	(PEG)-BHD1028 Multiple Ascending Dose	8, 16, and 32 μg/Kg
OTHER	Placebo	Diluent

Timeline

• Start date: 2022-04-18
• Primary completion: 2024-04-23
• Completion: 2024-06-23
• First posted: 2024-08-20
• Last updated: 2024-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study