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

NCT06563115 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-08-20

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • EncuraGen, Inc

    lead INDUSTRY

Principal Investigators

  • Martin Kankam, MD · Altasciences Clinical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-18
Primary Completion
2024-04-23
Completion
2024-06-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06563115 on ClinicalTrials.gov