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

Phase 1
Waitlist Available
Led By Martin Kankam, MD
Research Sponsored by EncuraGen, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose

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.

Eligible Conditions
  • Insulin Resistance

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and tolerability of (PEG)-BHD1028 -Multiple ascending dose as measured by TEAEs
Safety and tolerability of (PEG)-BHD1028 -Single ascending dose as measured by TEAEs
Secondary study objectives
Pharmacodynamics of (PEG)-BHD 1028 after multiple doses as measured by Insulin C -peptide
Pharmacodynamics of (PEG)-BHD 1028 after multiple doses as measured by glucose
Pharmacodynamics of (PEG)-BHD 1028 after multiple doses as measured by insulin
+16 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental (PEG)-BHD1028_Single Ascending DoseExperimental Treatment1 Intervention
Participants received a single escalated SC dose of (PEG)-BHD1028 on Day 1
Group II: Experimental (PEG)-BHD1028_Multiple Ascending DoseExperimental Treatment1 Intervention
Participants received SC doses of (PEG)-BHD1028 once a day for 28 days
Group III: Placebo_Single Ascending DosePlacebo Group1 Intervention
Participants received a single SC dose of placebo on Day 1
Group IV: Placebo_Multiple Ascending DosePlacebo Group1 Intervention
Participants received SC doses of placebo once a day for 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
(PEG)-BHD1028 Single Ascending Dose
2022
Completed Phase 1
~70
(PEG)-BHD1028 Multiple Ascending Dose
2022
Completed Phase 1
~70

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Who is running the clinical trial?

EncuraGen, IncLead Sponsor
Martin Kankam, MDPrincipal InvestigatorAltasciences Clinical
3 Previous Clinical Trials
186 Total Patients Enrolled
~17 spots leftby Dec 2025
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