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HAMS-AB in Newly Diagnosed Patients With Type 1 Diabetes (HAMS-AB-01B)

Primary Purpose

Type 1 Diabetes, Type 1 Diabetes (Juvenile Onset), Diabetes Mellitus, Type 1

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HAMS-AB
Placebo
Sponsored by
Rise Therapeutics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Newly Diagnosed children (age 11-17 years old) BMI <85% Diagnosed by ADA criteria with T1D within 2 years Accepted to adhere to a healthy diabetic diet as recommended by the ADA Exclusion Criteria: Monogenic forms of diabetes or type 2 diabetes History of ongoing infection or antibiotic treatment within the past four (4) weeks History of immunocompromised, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past six (6) months History of chronic gastrointestinal disease, possible or confirmed celiac disease Pregnancy or possible pregnancy Allergy to corn (prebiotic), milk allergy, soy (present in the MMTT meal) or their products Participation in other intervention research trials within the past three (3) months Anticipated major change in diabetes management during the study (e.g., change from injections to insulin pump therapy or new continuous monitor usage, all known to significantly alter glycemia) Children consuming a high-fiber or vegetarian diet (consuming three (3) or more servings of high fiber foods on four (4) or more days per week) or any fiber supplements will be excluded (to be assessed at screening) Any COVID vaccines within 30 days prior to Day 1

Sites / Locations

  • Indiana School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Comparator

Placebo Comparator

Arm Description

HAMS-AB, TAKEN TWICE A DAY, ORALLY WITH FOOD FOR 12 WEEKS (84 DAYS)

FOOD STARCH, TAKEN TWICE A DAY, ORALLY WITH FOOD FOR 12 WEEKS (84 DAYS)

Outcomes

Primary Outcome Measures

Measurement of adverse events from the date of the first dose through 12 weeks of HAMS-AB tolerance
The number of participants with treatment-related adverse events as evaluated by CTCAE v5.0, will be reviewed to see the results from baseline in toxicology scores at 12 Weeks compared to placebo.

Secondary Outcome Measures

Measurement of clinical activity and to determine the gut microbiome profile in youth with recently diagnosed Type 1 Diabetes
To measure the levels of glucose (in milligrams) in the blood at the beginning and again at 12 weeks, and the measurement of C-Peptide (in nanograms) in the blood at the beginning and again at 12 weeks versus placebo, changes in the type of gut bacteria at the beginning and again at 12 weeks versus placebo.

Full Information

First Posted
September 15, 2023
Last Updated
September 28, 2023
Sponsor
Rise Therapeutics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT06057454
Brief Title
HAMS-AB in Newly Diagnosed Patients With Type 1 Diabetes
Acronym
HAMS-AB-01B
Official Title
Evaluating the Safety and Tolerability of HAMS-AB in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rise Therapeutics LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluating the adverse events and tolerance of HAMS-AB in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
Detailed Description
Double blinded, placebo controlled, Phase 1B study assessing the safety and efficacy of 12 weeks daily administrations of HAMS-AB in newly diagnosed Type 1 Diabetes adolescents

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Type 1 Diabetes (Juvenile Onset), Diabetes Mellitus, Type 1
Keywords
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Double Blinided, placebo controlled, Phase 1B study.
Masking
ParticipantInvestigator
Masking Description
Double blind placebo controlled trial
Allocation
Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
HAMS-AB, TAKEN TWICE A DAY, ORALLY WITH FOOD FOR 12 WEEKS (84 DAYS)
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
FOOD STARCH, TAKEN TWICE A DAY, ORALLY WITH FOOD FOR 12 WEEKS (84 DAYS)
Intervention Type
Drug
Intervention Name(s)
HAMS-AB
Intervention Description
Modified Superior Starch
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Food Grade Starch
Primary Outcome Measure Information:
Title
Measurement of adverse events from the date of the first dose through 12 weeks of HAMS-AB tolerance
Description
The number of participants with treatment-related adverse events as evaluated by CTCAE v5.0, will be reviewed to see the results from baseline in toxicology scores at 12 Weeks compared to placebo.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Measurement of clinical activity and to determine the gut microbiome profile in youth with recently diagnosed Type 1 Diabetes
Description
To measure the levels of glucose (in milligrams) in the blood at the beginning and again at 12 weeks, and the measurement of C-Peptide (in nanograms) in the blood at the beginning and again at 12 weeks versus placebo, changes in the type of gut bacteria at the beginning and again at 12 weeks versus placebo.
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly Diagnosed children (age 11-17 years old) BMI <85% Diagnosed by ADA criteria with T1D within 2 years Accepted to adhere to a healthy diabetic diet as recommended by the ADA Exclusion Criteria: Monogenic forms of diabetes or type 2 diabetes History of ongoing infection or antibiotic treatment within the past four (4) weeks History of immunocompromised, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past six (6) months History of chronic gastrointestinal disease, possible or confirmed celiac disease Pregnancy or possible pregnancy Allergy to corn (prebiotic), milk allergy, soy (present in the MMTT meal) or their products Participation in other intervention research trials within the past three (3) months Anticipated major change in diabetes management during the study (e.g., change from injections to insulin pump therapy or new continuous monitor usage, all known to significantly alter glycemia) Children consuming a high-fiber or vegetarian diet (consuming three (3) or more servings of high fiber foods on four (4) or more days per week) or any fiber supplements will be excluded (to be assessed at screening) Any COVID vaccines within 30 days prior to Day 1
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janet Stephens, PhD
Phone
6504178556
Email
jstephens@risetherapeutics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Freguia, PhD
Phone
2159231818
Email
cfreguia@risetherapeutics.com
Facility Information:
Facility Name
Indiana School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heba Ismail

12. IPD Sharing Statement

Learn more about this trial

HAMS-AB in Newly Diagnosed Patients With Type 1 Diabetes

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