Multiple Ascending Dose Study of MHS552 in Adults With Type 1 Diabetes Mellitus

NCT05272059 | Withdrawn Phase 1

• 1 other identifier: CMHS552B12101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this two-part multiple ascending dose study is to evaluate the safety and tolerability of multiple doses of MHS552 in adults with type 1 diabetes mellitus. Participants will be treated for 4 or 12 weeks followed by an 8 week follow-up period

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes mellitus, T1DM

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)

  Numbers of participants with AEs and SAEs including vital signs, electrocardiograms (ECG) and laboratory results

  Part A: up to 12 weeks; Part B: up to 20 weeks

Secondary Outcomes (3)

• Area Under Plasma Concentration-time Curve calculated to the end of a dosing interval (AUCtau) for MHS552

  Part A: up to Day 78; Part B: up to Day 134

• Maximum ObservBlood Concentrations (Cmax) for MHS552

  Part A: up to Day 78; Part B: up to Day 134

• Time to Reach Maximum Blood Concentrations (Tmax) of MHS552

  Part A: up to Day 78; Part B: up to Day 134

Study Arms (6)

Part A: Cohort 1 - MHS552 low dose

EXPERIMENTAL

Participants will receive MHS552 low dose once weekly subcutaneously for 4 weeks

Drug: MHS552

Part A: Cohort 1, 2, 3 - Placebo

PLACEBO COMPARATOR

Participants will receive placebo once weekly subcutaneously for 4 weeks

Drug: Placebo

Part A: Cohort 2 - MHS552 medium dose

EXPERIMENTAL

Participants will receive MHS552 medium dose once weekly subcutaneously for 4 weeks

Drug: MHS552

Part A: Cohort 3 - MHS552 high dose

EXPERIMENTAL

Participants will receive MHS552 high dose once weekly subcutaneously for 4 weeks

Drug: MHS552

Part B: MHS552

EXPERIMENTAL

Participants will MHS552 (dose to be determined) once weekly subcutaneously for 12 weeks

Drug: MHS552

Part B: Placebo

PLACEBO COMPARATOR

Participants will receive placebo once weekly subcutaneously for 12 weeks

Drug: Placebo

Interventions

MHS552 DRUG

MHS552 will be administered once weekly as subcutaneous injection for 4 (Part A) or 12 weeks (Part B)

Part A: Cohort 1 - MHS552 low dose; Part A: Cohort 2 - MHS552 medium dose; Part A: Cohort 3 - MHS552 high dose; Part B: MHS552

Placebo DRUG

Placebo will be administered once weekly as subcutaneous injection for 4 (Part A) or 12 weeks (Part B)

Part A: Cohort 1, 2, 3 - Placebo; Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult men and women ages 18 to 45, inclusive, body weight between ≥40 to ≤150 kg, inclusive, with T1DM, a maximum of 5 years from T1DM diagnosis at screening.
• Evidence of one or more T1DM autoantibody(ies) including glutamic acid decarboxylase (anti GAD), protein tyrosine, phosphatase-like protein (anti-IA-2); zinc transporter 8 (anti-ZnT8); islet cell (cytoplasmic) (anti-ICA)
• Residual pancreatic β-cell function (fasting C-peptide \>100 pmol/L \[0.30 ng/mL\] or random C peptide \>200 pmol/L \[0.60 ng/mL\])

You may not qualify if:

• History of hypersensitivity to drugs of similar biological class, IL-2 protein analogues, or immunoglobulin (IgG1) proteins, hypersensitivity to any components of the study drug, or history of severe hypersensitivity reaction or anaphylaxis to biological agents, e.g. human monoclonal antibody.
• Use of other investigational drugs or use of immunosuppressive agents at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or longer if required by local regulations.
• Diabetes forms other than autoimmune type 1 such as maturity-onset diabetes of the young (MODY), latent autoimmune diabetes of the adult (LADA), acquired diabetes (secondary to medications or surgery), type 2 diabetes by judgement of the investigator.
• Diabetic ketoacidosis within 2 weeks.
• History of capillary leak syndrome (CLS).
• Ongoing, and up to 2 weeks prior to screening, initiation of medications or change in dose of medications that may affect glucose control (e.g, systemic steroids, thiazides, beta blockers).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: September 1, 2023
• Primary Completion: April 14, 2025
• Study Completion: April 14, 2025
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share