Type1 DiabetesPhase 1NCT04625595

Multiple Ascending Dose (MAD) Study of IMT-002 in HLA-DQ8-positive Type 1 Diabetes

A Phase 1 study of Type1 Diabetes, run by Immunomolecular Therapeutics, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is designed to characterize the safety, steady-state pharmacokinetics (PK) of IMT-002, and will serve as a dose range identification for the pharmacodynamic effect of blocking self-antigen presentation in adults with type 1 diabetes (T1D) having the human leukocyte antigen (HLA)-DQ8 gene. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Type1 Diabetes
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 3 sitesUnited States
Study dates: 9 Nov 2020to 31 Jul 2021
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 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Signed the ICF as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Man or woman, 18 to 45 years of age inclusive at the time of signing the ICF.
Has received a diagnosis of T1D according to the criteria from the American Diabetes Association.
Positive for at least one gene encoding for HLA-DQ8 (DQB*0302).
If male, and of reproductive potential, willing to use medically acceptable birth control (Appendix 5), unless the female partner is postmenopausal or surgically sterile, until study completion and for at least 30 days after the last dose of study treatment and refrain from donating sperm during this period.
If female: (a) surgically sterile or (b) postmenopausal or (c) if of reproductive potential, willing to use medically acceptable birth control (eg, female hormonal contraception, barrier methods or sterilization (Appendix 5) until study completion and for at least 30 days (one menstrual cycle).

Who cannot join

Inability or unwillingness of a subject to give written informed consent or comply with the study protocol.
No HLA-DQ8 gene (DQB*03:02).
Any of the following hematologic abnormalities at the time of screening, confirmed by repeat tests:
Leukopenia (<3,000 leukocytes/μL)
Neutropenia (<1,500 neutrophils/μL)
Thrombocytopenia (<125,000 platelets/μL)

Show all 25Show fewer

Hemoglobin less than 10 g/dl
Evidence of liver dysfunction, with ALT > 2.5 times the upper limit of normal (ULN) or AST >3.0 times ULN persistent for 1 week or greater.
Evidence of renal insufficiency as indicated by serum creatinine of >1.5 times ULN, confirmed by a repeat test.
Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at screening as deemed appropriate by the investigator.
Has a history of or current clinically significant medical illness including, but not limited to, cardiac arrhythmias or other cardiac disease; significant pulmonary disease; neurologic or psychiatric disease; infection; or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results.
Body mass index (BMI) > 32 kg/m2.
Unstable blood sugar control defined as one or more episodes of severe hypoglycemia (defined as hypoglycemia that required the assistance of another person) within the last 30 days.
Use of a treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, within 4 weeks prior to participation; this includes high-dose inhaled, extensive topical or systemic glucocorticoids.
History of any organ transplant, including islet cell transplant.
Pregnant or anticipates pregnancy during the 2-week study period or within 30 days following the last dose of study drug.
Use of investigational drugs within 90 days of participation.
Currently taking methyldopa (Aldomet) at the time of randomization or taken within the past 3 months.
Currently taking ferrous sulfate or ferrous gluconate, which are indicated for the treatment of anemia (hematological disease), or taken within the past 30 days.
Unable to avoid medications that affect stomach pH, such as proton pump inhibitors or histamine H2 receptor blockers.
Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the Investigator, may pose additional risks from participation in the study, may interfere with the subject's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
Has a history of the human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or another clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
Has preplanned surgery or procedures that would interfere with the conduct of the study.
Is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, as well as family members of the employees or the Investigator.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Barbara Davis Center
Aurora, Colorado, 80045
Prosciento, Inc.
Chula Vista, California, 91911
Rainier Clinical Research Center
Renton, Washington, 98057

Other trials in United States

About this study

Official title: A Phase 1b, Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose (MAD) Study to Assess the Steady-State Pharmacokinetics and DQ8 Blocking Efficacy of Orally Administered IMT-002 in Patients With Type 1 Diabetes and HLA-DQ8

Read the detailed description

This is a randomized, single-blind, placebo-controlled study that will include 4 ascending dose cohorts: 350 mg twice daily (BID), 1050 mg once daily (QD), 700 mg BID, and 1050 mg BID. Subjects will undergo prescreening for genetic typing and then screening procedures up to 28 days prior to the first dose to determine eligibility. T1D adults between 18 and 45 years of age, inclusive, who are positive for at least one gene encoding for HLA-DQ8 (DQA1*0301, DQB1*0302) will be enrolled.

Each cohort will include 6 subjects on active drug, and the study will include 6 subjects total on placebo. Each cohort will participate in a 2-week dosing period. Enrollment of the cohorts will be sequentially staggered such that initial safety data after the first four subjects assigned to active treatment complete one week of treatment in each cohort will be reviewed before the next ascending dose cohort is enrolled. The safety reviews will include cumulative safety data for all subjects to that point. Subjects will have 5 scheduled clinic visits: screening, first day of dosing, 1 week after dosing begins, 2 weeks after dosing begins (end of treatment), and 1 week following the final dose. Subjects will self-administer study drug on non-clinic treatment days. Safety assessments will be conducted at all study visits. Insulin use (dose and frequency) will be monitored.

Pharmacokinetic (PK) assessments will be evaluated at every visit during the treatment period to characterize the following: single dose PK, trough PK and steady PK. Pharmacodynamic (PD) and immunological assessments will be evaluated before, during and after treatment.

Conditions: Type1 Diabetes
Being tested: 350mg BID (700mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule, 700mg BID (1400mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule, 1050mg QD (1050mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule, 1050mg BID (2100mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule
Keywords: diabetes, prescreening, autoimmunity, HLA
Medical subject headings: Diabetes Mellitus, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

350mg BID (700mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuleDrug
Also called 350mg BID
Oral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily
700mg BID (1400mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuleDrug
Also called 700mg BID
Oral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily
1050mg QD (1050mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuleDrug
Also called 1050mg QD
Oral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily
1050mg BID (2100mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuleDrug
Also called 1050mg BID
Oral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily

Study groups in NCT04625595
Study group	Role	What they receive
350 mg BID (700 mg total daily dose) of active drug or placebo	Experimental	Low dose, drug IMT-002 Receives: Drug: 350mg BID (700mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule
1050 mg QD (1050 mg total daily dose) of active drug or placebo	Experimental	Moderate dose, drug IMT-002 Receives: Drug: 1050mg QD (1050mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule
700 mg BID (1400 mg total daily dose) of active drug or placebo	Experimental	Moderate to high dose, drug IMT-002 Receives: Drug: 700mg BID (1400mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule
1050 mg BID (2100 mg total daily dose) of active drug or placebo	Experimental	High dose, drug IMT-002 Receives: Drug: 1050mg BID (2100mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of adverse events (AEs) and serious adverse events (SAEs)
Frequency tabulated as number of participants with adverse and serious adverse events (AEs)
Measured: Treatment and follow-up period, Day 21
Change from baseline in electrocardiogram (ECG)
Single 12-lead ECG will be measured in a supine position after 5 minutes rest and measure QRS, QT, and QTc intervals
Measured: Day 1, Day 7, Day 14 and Day 21
Change in total daily insulin use
At each study visit, total daily insulin (ie, total insulin administered over the previous 24-hour period) will be entered in the Concomitant Medications CRF
Measured: Day 1, Day 7, Day 14 and Day 21

Secondary outcomes (2)

Pharmacokinetic (PK) measurement in blood plasma, Cmax
Cmax, maximum plasma concentration during a dosing interval
Measured: Day 1, Day 7, Day 14
Cytokine level from in vitro presentation of antigen by HLA-DQ8
Change from baseline of cytokine, interleukin-2, level produced in T-cell based in vitro assay of blood sample resulting from presentation of insulin or gluten peptide antigen by HLA-DQ8
Measured: Day 1, Day 7, Day 14 and Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 202031 Jul 2021

First posted12 Nov 2020
Study start9 Nov 2020
Primary completion11 May 2021
Study completion31 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Type1 DiabetesStudies 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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04625595
Sponsor's protocol ID: IMT-002-0102
Status last verified: Jun 2021
First submitted: 20 Oct 2020
Last updated: 25 Aug 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Ostrov DA, Alkanani A, McDaniel KA, Case S, Baschal EE, Pyle L, Ellis S, Pollinger B, Seidl KJ, Shah VN, Garg SK, Atkinson MA, Gottlieb PA, Michels AW. Methyldopa blocks MHC class II binding to disease-specific antigens in autoimmune diabetes. J Clin Invest. 2018 May 1;128(5):1888-1902. doi: 10.1172/JCI97739. Epub 2018 Apr 3.
PubMed 29438107
Ostrov DA, Gottlieb PA, Michels AW. Rationally designed small molecules to prevent type 1 diabetes. Curr Opin Endocrinol Diabetes Obes. 2019 Apr;26(2):90-95. doi: 10.1097/MED.0000000000000470.
PubMed 30694829
Au WY, Dring LG, Grahame-Smith DG, Isaac P, Williams RT. The metabolism of 14 C-labelled -methyldopa in normal and hypertensive human subjects. Biochem J. 1972 Aug;129(1):1-10. doi: 10.1042/bj1290001.
PubMed 4646774
GILLESPIE L Jr, OATES JA, CROUT JR, SJOERDSMA A. Clinical and chemical studies with alpha-methyl-dopa in patients with hypertension. Circulation. 1962 Feb;25:281-91. doi: 10.1161/01.cir.25.2.281. No abstract available.
PubMed 13898638
SJOERDSMA A, VENDSALU A, ENGELMAN K. STUDIES ON THE METABOLISM AND MECHANISM OF ACTION OF METHYLDOPA. Circulation. 1963 Oct;28:492-502. doi: 10.1161/01.cir.28.4.492. No abstract available.
PubMed 14068757

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b, Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose (MAD) Study to Assess the Steady-State Pharmacokinetics and DQ8 Blocking Efficacy of Orally Administered IMT-002 in Patients With Type 1 Diabetes and HLA-DQ8
ClinicalTrials.gov ID: NCT04625595
Acronym / sponsor ID: IMT-002-0102
Conditions: Type1 Diabetes
Keywords: diabetes, prescreening, autoimmunity, HLA
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Immunomolecular Therapeutics, Inc.Industry (pharma, biotech, devices)
Collaborators: WCCT Global
Study start: 9 Nov 2020 (actual)
Primary completion: 11 May 2021 (actual)
Study completion: 31 Jul 2021 (actual)
First posted: 12 Nov 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
350 mg BID (700 mg total daily dose) of active drug or placebo	Experimental	Drug: 350mg BID (700mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuleLow dose, drug IMT-002
1050 mg QD (1050 mg total daily dose) of active drug or placebo	Experimental	Drug: 1050mg QD (1050mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuleModerate dose, drug IMT-002
700 mg BID (1400 mg total daily dose) of active drug or placebo	Experimental	Drug: 700mg BID (1400mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuleModerate to high dose, drug IMT-002
1050 mg BID (2100 mg total daily dose) of active drug or placebo	Experimental	Drug: 1050mg BID (2100mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuleHigh dose, drug IMT-002

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Signed the ICF as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Man or woman, 18 to 45 years of age inclusive at the time of signing the ICF.
Has received a diagnosis of T1D according to the criteria from the American Diabetes Association.
Positive for at least one gene encoding for HLA-DQ8 (DQB*0302).
If male, and of reproductive potential, willing to use medically acceptable birth control (Appendix 5), unless the female partner is postmenopausal or surgically sterile, until study completion and for at least 30 days after the last dose of study treatment and refrain from donating sperm during this period.

Key exclusion criteria (25 listed)

Inability or unwillingness of a subject to give written informed consent or comply with the study protocol.
No HLA-DQ8 gene (DQB*03:02).
Any of the following hematologic abnormalities at the time of screening, confirmed by repeat tests:
Evidence of liver dysfunction, with ALT > 2.5 times the upper limit of normal (ULN) or AST >3.0 times ULN persistent for 1 week or greater.
Evidence of renal insufficiency as indicated by serum creatinine of >1.5 times ULN, confirmed by a repeat test.

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
350mg BID (700mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuleAlso: 350mg BIDOral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily	Drug	350 mg BID (700 mg total daily dose) of active drug or placebo
700mg BID (1400mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuleAlso: 700mg BIDOral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily	Drug	700 mg BID (1400 mg total daily dose) of active drug or placebo
1050mg QD (1050mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuleAlso: 1050mg QDOral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily	Drug	1050 mg QD (1050 mg total daily dose) of active drug or placebo
1050mg BID (2100mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuleAlso: 1050mg BIDOral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily	Drug	1050 mg BID (2100 mg total daily dose) of active drug or placebo

Primary outcome

Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Treatment and follow-up period, Day 21
Frequency tabulated as number of participants with adverse and serious adverse events (AEs)
Change from baseline in electrocardiogram (ECG)
Time frame: Day 1, Day 7, Day 14 and Day 21
Single 12-lead ECG will be measured in a supine position after 5 minutes rest and measure QRS, QT, and QTc intervals
Change in total daily insulin use
Time frame: Day 1, Day 7, Day 14 and Day 21
At each study visit, total daily insulin (ie, total insulin administered over the previous 24-hour period) will be entered in the Concomitant Medications CRF

2 secondary outcomes

Pharmacokinetic (PK) measurement in blood plasma, Cmax
Time frame: Day 1, Day 7, Day 14
Cytokine level from in vitro presentation of antigen by HLA-DQ8
Time frame: Day 1, Day 7, Day 14 and Day 21

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 25 Aug 2021.
Background: PubMed 29438107Ostrov DA, Alkanani A, McDaniel KA, Case S, Baschal EE, Pyle L, Ellis S, Pollinger B, Seidl KJ, Shah VN, Garg SK, Atkinson MA, Gottlieb PA, Michels AW. Methyldopa blocks MHC class II binding to disease-specific antigens in autoimmune diabetes. J Clin Invest. 2018 May 1;128(5):1888-1902. doi: 10.1172/JCI97739. Epub 2018 Apr 3.
Background: PubMed 30694829Ostrov DA, Gottlieb PA, Michels AW. Rationally designed small molecules to prevent type 1 diabetes. Curr Opin Endocrinol Diabetes Obes. 2019 Apr;26(2):90-95. doi: 10.1097/MED.0000000000000470.
Background: PubMed 4646774Au WY, Dring LG, Grahame-Smith DG, Isaac P, Williams RT. The metabolism of 14 C-labelled -methyldopa in normal and hypertensive human subjects. Biochem J. 1972 Aug;129(1):1-10. doi: 10.1042/bj1290001.
Background: PubMed 13898638GILLESPIE L Jr, OATES JA, CROUT JR, SJOERDSMA A. Clinical and chemical studies with alpha-methyl-dopa in patients with hypertension. Circulation. 1962 Feb;25:281-91. doi: 10.1161/01.cir.25.2.281. No abstract available.
Background: PubMed 14068757SJOERDSMA A, VENDSALU A, ENGELMAN K. STUDIES ON THE METABOLISM AND MECHANISM OF ACTION OF METHYLDOPA. Circulation. 1963 Oct;28:492-502. doi: 10.1161/01.cir.28.4.492. No abstract available.
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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Type1 Diabetes, run by Immunomolecular Therapeutics, Inc. at 3 sites 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 6 inclusion and 25 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 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. 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?

Incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: Treatment and follow-up period, Day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04625595, which also lists 5 linked publications.

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 25 Aug 2021.