Insulin ResistancePhase 1NCT06563115
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of (PEG)-BHD1028
A Phase 1 study testing (PEG)-BHD1028 Single Ascending Dose and (PEG)-BHD1028 Multiple Ascending Dose in people with Insulin Resistance, run by EncuraGen, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- (PEG)-BHD1028 Single Ascending Dose and (PEG)-BHD1028 Multiple Ascending Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 23 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c < 6.5 % by local laboratory analysis (one retest is permitted)
- Body Mass Index (BMI) ≥ 27 kg/m2
- HOMA-IR ≥ 1.8
- Female subjects must be non-pregnant and non-lactating, and females of childbearing potential must have used a stable regimen of highly effective contraceptive methods (for at least 2 months prior to the Screening) that they were willing to continue for at least 30 days after the last dose of the study drug.
- Male subjects must be surgically sterile, abstinent or, if engaged in sexual relations with a woman of childbearing potential, the subject and his partner must use an acceptable method of contraception for at least 90 days after the last dose of the study drug.
- Ability and willingness to comply with all protocol procedures
- Ability to provide written informed consent
Who cannot join
- History of type 1 or 2 diabetes mellitus (T1DM, T2DM)
- Systolic blood pressure > 159 mm Hg or diastolic blood pressure > 99 mmHg at ----Screening (reading may be repeated on a different day)
- Treatment with antihypertensive medication or statins if the medication was not stable during the 2 months prior to Screening
- Treatment with thyroid hormones was not stable during the 3 months prior to Screening
- History of any weight control treatment, including over-the-counter and herbal medication and supplements, or any medication with a labeled indication for weight loss or weight gain within 30 days prior to Screening
- History of gastrointestinal surgery for obesity that may induce malabsorption, or any malabsorption disorder, or clinically significant (C.S.) ongoing gastrointestinal disorders (including gastroparesis, peptic ulcers, and severe gastrointestinal reflux disease)
Show all 27Show fewer
- History of symptomatic heart failure (New York Heart Association class II, III, or IV), myocardial infarction, unstable angina, transient ischemic attack, cerebral infarct, cerebral hemorrhage, or invasive cardiovascular procedure (including coronary artery bypass grafting [CABG] and percutaneous coronary intervention [PCI]) within 6 months of Screening
- Presence of CS ECG findings (including corrected Q.T. interval using Fridericia's formula [QTcF] > 450 msec for males, QTcF > 470 msec for females, left bundle branch block [LBBB]) at Screening, or cardiac arrhythmia requiring medical or surgical treatment within 6 months prior to Screening
- Presence of any C.S. physical, laboratory, ECG finding, or medical condition (including moderate to severe osteoarthritis or other C.S. rheumatological disease), that (in the opinion of an Investigator) may interfere with any aspect of the study conduct or interpretation of results
- Estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73 m2 at Screening (using the Modification of Diet in Renal Disease [MDRD] equation)
- Clinically significant disease (within the last five years) of the gastrointestinal, cardiovascular, hepatic, neurological, renal, pancreatic, immunological, dermatological, endocrine, genitourinary or hematological system
- Chronic liver disease, HIV, HBV- or active HCV infection, or a positive test at Screening
- History of mental handicap, major depression, suicidal behavior or attempts, or other psychiatric disorders requiring medical treatment (within 2 years of Screening), including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), antipsychotics, lithium, or other psychiatric disorders including eating disorders and seizures
- Fasting triglycerides > 500 mg/dL or alanine aminotransferase (ALT) and/or (aspartate aminotransferase ) AST d> 2 x upper limit of normal (ULN) (a single retest of triglycerides, ALT, or AST was allowed)
- Use of any drugs that were known to interfere with glucose or insulin metabolism, including oral corticosteroids, glucagon-like peptide-1 (GLP-1) receptor agonists, monoamine oxidase (MAO) inhibitors, and growth hormone, or use of non-prescription drugs within 7 days of first dosing
- Administration of vaccines/immunizations within 14 days prior to the initiation of dosing
- Major surgery within 8 weeks prior to Screening
- History of, or suspected allergy or hypersensitivity to the investigational product (I.P.) components
- History of any active infection within 14 days prior to Screening
- Participation in any other clinical interventional study receiving active treatment within 30 days or 5 half-lives prior to Screening, whichever was longer
- History of alcohol or illicit drug abuse, including marijuana, or a positive drug test at Screening
- History of alcohol abuse within approximately 1 year, or average daily alcohol intake >2 drinks for men and > 1 drink of alcoholic beverages for women, or positive alcohol breath test at Screening
- Daily use of more than 15 cigarettes/week or equivalent use of any tobacco product within 6 weeks prior to Screening, or inability to abstain from smoking during the study
- Existence of any surgical or medical condition that, in the judgment of an Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the IP
- A history of fainting from blood collections or vasovagal syncope
- Any anticipated procedures that might have interfered with compliance or completion of the study
- Donation or loss of > 500 mL of blood or blood product within 56 days prior to Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- (PEG)-BHD1028 Single Ascending Dose, (PEG)-BHD1028 Multiple Ascending Dose, Placebo
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(PEG)-BHD1028 Single Ascending DoseDrug
Also called adiponectin receptor agonist
4, 8, 16, 32, and 64 μg/Kg
(PEG)-BHD1028 Multiple Ascending DoseDrug
Also called adiponectin receptor agonist
8, 16, and 32 μg/Kg
PlaceboOther
Diluent
| Study group | Role | What they receive |
|---|---|---|
| Placebo_Single Ascending Dose | Placebo comparator | Participants received a single SC dose of placebo on Day 1 Receives: Other: Placebo |
| Experimental (PEG)-BHD1028_Single Ascending Dose | Experimental | Participants received a single escalated SC dose of (PEG)-BHD1028 on Day 1 Receives: Drug: (PEG)-BHD1028 Single Ascending Dose |
| Placebo_Multiple Ascending Dose | Placebo comparator | Participants received SC doses of placebo once a day for 28 days Receives: Other: Placebo |
| Experimental (PEG)-BHD1028_Multiple Ascending Dose | Experimental | Participants received SC doses of (PEG)-BHD1028 once a day for 28 days Receives: Drug: (PEG)-BHD1028 Multiple Ascending Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of (PEG)-BHD1028 -Single ascending dose as measured by TEAEs
Treatment emergent adverse events (including clinical AEs and Lab AEs) after a single dose of (PEG)-BHD1028 (including clinical AEs and Lab AEs) of (PEG)-BHD1028
Measured: Baseline to Day 3
Safety and tolerability of (PEG)-BHD1028 -Multiple ascending dose as measured by TEAEs
Treatment emergent adverse events (including clinical AEs and Lab AEs) after multiple doses of (PEG)-BHD1028
Measured: Baseline to Day 29
Secondary outcomes (19)
Pharmacokinetics of (PEG)-BHD1028 after a single dose, Cmax
Maximum plasma concentration of (PEG)-BHD1028
Measured: pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
Pharmacokinetics of (PEG)-BHD1028 after a single dose, Tmax
Time to reach Maximum plasma concentration of (PEG)-BHD1028
Measured: pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
Pharmacokinetics of (PEG)-BHD1028 after a single dose, t1/2
Time to reach apparent (PEG)-BHD1028 apparent terminal half life
Measured: pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
Pharmacokinetics of (PEG)-BHD1028 after a single dose, AUClast
Area under the (PEG)-BHD1028 concentration -time curve up to the last measurable concentration in serum
Measured: pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
Pharmacokinetics of (PEG)-BHD1028 after a single dose, AUCinf
AUCinf Area under the (PEG)-BHD1028 concentration -time curve up extrapolated to infinity
Measured: pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
Pharmacokinetics of (PEG)-BHD1028 after a single dose, CL/F
CL/F Apparent clearance of the drug calculated as dose of drug divided by the AUC
Measured: pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
Pharmacokinetics of (PEG)-BHD1028 after a single dose, Vd/F
Apparent Volume of distribution calculated as Total administered dose/initial plasma concentration
Measured: pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, Cmax
Maximum plasma concentration of (PEG)-BHD1028
Measured: pre-dose, and post dose on Day 1, Day 14 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, Tmax
Time to reach Maximum plasma concentration of (PEG)-BHD1028
Measured: pre-dose, and post dose on Day 1, Day 14 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, Cav,ss
Average plasma concentrate at steady state
Measured: pre-dose, and post dose on Day 1, Day 14 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, AUCtau
Area under the (PEG)-BHD1028 concentration -time curve up to the last dose
Measured: pre-dose, and post dose on Day 1, Day 14 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, t1/2
Time to reach (PEG)-BHD1028 apparent terminal half life
Measured: pre-dose, and post dose on Day 1, Day 14 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, CLss/F
Apparent plasma clearance of drug after extravascular administration at steady state
Measured: pre-dose, and post dose on Day 1, Day 14 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, Vd/F
Apparent volume of distribution after extravascular administration
Measured: pre-dose, and post dose on Day 1, Day 14 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, Rac(Cmax)
Accumulation ratio calculated as Cmax (day 28)/ Cmax (day 1)
Measured: post dose on Day 1 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, Rac(AUC)
Accumulation ratio calculated as AUC0-t (day 28)/ AUC0-t (day 1)
Measured: post dose on Day 1 and Day 28
Pharmacodynamics of (PEG)-BHD 1028 after multiple doses as measured by Insulin C -peptide
Insulin c-peptide as assessed by the net AUC at baseline and the percentage change from baseline. Responders defined as subjects which exhibited a reduction in insulin c-peptide AUC during the Mixed Meal Tolerance Test (MMTT) of at least 15% from Day -1 to Day 28.
Measured: Day -1 and Day 28
Pharmacodynamics of (PEG)-BHD 1028 after multiple doses as measured by insulin
Insulin AUC as assessed by the net AUC at baseline and the percentage change from baseline during the Mixed Meal Tolerance Test (MMTT).
Measured: Day -1 and Day 28
Pharmacodynamics of (PEG)-BHD 1028 after multiple doses as measured by glucose
Fasting plasma glucose (FPG), Post-prandial glucose (PPG), and glucose AUC assessed during the Mixed Meal Tolerance Test (MMTT).
Measured: Day -1 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start18 Apr 2022
- Primary completion23 Apr 2024
- Study completion23 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- EncuraGen, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Kankam, MD, Principal investigator, Altasciences Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563115
- Sponsor's protocol ID
- ECN1028-101
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06563115
- Acronym / sponsor ID
- ECN1028-101
- Conditions
- Insulin Resistance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- EncuraGen, IncIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Jun 2024 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study
| Arm | Type | Receives |
|---|---|---|
| Placebo_Single Ascending Dose | Placebo comparator | Other: PlaceboParticipants received a single SC dose of placebo on Day 1 |
| Experimental (PEG)-BHD1028_Single Ascending Dose | Experimental | Drug: (PEG)-BHD1028 Single Ascending DoseParticipants received a single escalated SC dose of (PEG)-BHD1028 on Day 1 |
| Placebo_Multiple Ascending Dose | Placebo comparator | Other: PlaceboParticipants received SC doses of placebo once a day for 28 days |
| Experimental (PEG)-BHD1028_Multiple Ascending Dose | Experimental | Drug: (PEG)-BHD1028 Multiple Ascending DoseParticipants received SC doses of (PEG)-BHD1028 once a day for 28 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HbA1c < 6.5 % by local laboratory analysis (one retest is permitted)
- Body Mass Index (BMI) ≥ 27 kg/m2
- HOMA-IR ≥ 1.8
- Female subjects must be non-pregnant and non-lactating, and females of childbearing potential must have used a stable regimen of highly effective contraceptive methods (for at least 2 months prior to the Screening) that they were willing to continue for at least 30 days after the last dose of the study drug.
- Male subjects must be surgically sterile, abstinent or, if engaged in sexual relations with a woman of childbearing potential, the subject and his partner must use an acceptable method of contraception for at least 90 days after the last dose of the study drug.
Key exclusion criteria (27 listed)
- History of type 1 or 2 diabetes mellitus (T1DM, T2DM)
- Systolic blood pressure > 159 mm Hg or diastolic blood pressure > 99 mmHg at ----Screening (reading may be repeated on a different day)
- Treatment with antihypertensive medication or statins if the medication was not stable during the 2 months prior to Screening
- Treatment with thyroid hormones was not stable during the 3 months prior to Screening
- History of any weight control treatment, including over-the-counter and herbal medication and supplements, or any medication with a labeled indication for weight loss or weight gain within 30 days prior to Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (PEG)-BHD1028 Single Ascending DoseAlso: adiponectin receptor agonist4, 8, 16, 32, and 64 μg/Kg | Drug | Experimental (PEG)-BHD1028_Single Ascending Dose |
| (PEG)-BHD1028 Multiple Ascending DoseAlso: adiponectin receptor agonist8, 16, and 32 μg/Kg | Drug | Experimental (PEG)-BHD1028_Multiple Ascending Dose |
| PlaceboDiluent | Other | Placebo_Multiple Ascending Dose, Placebo_Single Ascending Dose |
Primary outcome
Safety and tolerability of (PEG)-BHD1028 -Single ascending dose as measured by TEAEs
Time frame: Baseline to Day 3
Treatment emergent adverse events (including clinical AEs and Lab AEs) after a single dose of (PEG)-BHD1028 (including clinical AEs and Lab AEs) of (PEG)-BHD1028
Safety and tolerability of (PEG)-BHD1028 -Multiple ascending dose as measured by TEAEs
Time frame: Baseline to Day 29
Treatment emergent adverse events (including clinical AEs and Lab AEs) after multiple doses of (PEG)-BHD1028
19 secondary outcomes
Pharmacokinetics of (PEG)-BHD1028 after a single dose, Cmax
Time frame: pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
Pharmacokinetics of (PEG)-BHD1028 after a single dose, Tmax
Time frame: pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
Pharmacokinetics of (PEG)-BHD1028 after a single dose, t1/2
Time frame: pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
Pharmacokinetics of (PEG)-BHD1028 after a single dose, AUClast
Time frame: pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
Pharmacokinetics of (PEG)-BHD1028 after a single dose, AUCinf
Time frame: pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
Pharmacokinetics of (PEG)-BHD1028 after a single dose, CL/F
Time frame: pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
Pharmacokinetics of (PEG)-BHD1028 after a single dose, Vd/F
Time frame: pre-dose, and at 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr after the single dose
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, Cmax
Time frame: pre-dose, and post dose on Day 1, Day 14 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, Tmax
Time frame: pre-dose, and post dose on Day 1, Day 14 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, Cav,ss
Time frame: pre-dose, and post dose on Day 1, Day 14 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, AUCtau
Time frame: pre-dose, and post dose on Day 1, Day 14 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, t1/2
Time frame: pre-dose, and post dose on Day 1, Day 14 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, CLss/F
Time frame: pre-dose, and post dose on Day 1, Day 14 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, Vd/F
Time frame: pre-dose, and post dose on Day 1, Day 14 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, Rac(Cmax)
Time frame: post dose on Day 1 and Day 28
Pharmacokinetics of (PEG)-BHD1028 after multiple doses, Rac(AUC)
Time frame: post dose on Day 1 and Day 28
Pharmacodynamics of (PEG)-BHD 1028 after multiple doses as measured by Insulin C -peptide
Time frame: Day -1 and Day 28
Pharmacodynamics of (PEG)-BHD 1028 after multiple doses as measured by insulin
Time frame: Day -1 and Day 28
Pharmacodynamics of (PEG)-BHD 1028 after multiple doses as measured by glucose
Time frame: Day -1 and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Kankam, MD principal investigator
Altasciences Clinical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing (PEG)-BHD1028 Single Ascending Dose and (PEG)-BHD1028 Multiple Ascending Dose in people with Insulin Resistance, run by EncuraGen, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of (PEG)-BHD1028 -Single ascending dose as measured by TEAEs (time frame: Baseline to Day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.