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Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06036784
Recruitment Status : Recruiting
First Posted : September 14, 2023
Last Update Posted : February 22, 2024
Sponsor:
Collaborator:
ProSciento, Inc.
Information provided by (Responsible Party):
MBX Biosciences

Study Description
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Brief Summary:

The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses and Drug Drug Interaction of MBX 1416 in healthy volunteers

This study includes 3 parts. Part A involves a single dose of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part B involves repeat doses of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part C involves the evaluation of rosuvastatin and acetaminophen pharmacokinetics in the presence and absence of MBX 1416.


Condition or disease Intervention/treatment Phase
Postbariatric Hypoglycemia Drug: MBX 1416 (Part A) Drug: MBX 1416 (Part B) Drug: Placebo Drug: MBX 1416 (Part C) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Basic Science
Official Title: A Phase 1 Single and Multiple Ascending Dose and Drug Drug Interaction Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
Actual Study Start Date : September 18, 2023
Estimated Primary Completion Date : October 17, 2024
Estimated Study Completion Date : October 17, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: MBX 1416 (Part A)
Single ascending subcutaneous (SC) doses
 Drug: MBX 1416 (Part A)
Single Ascending subcutaneous (SC) dose of MBX 1416: 10mg, 30mg,100mg, 200mg
Experimental: MBX 1416 (Part B)
Repeated ascending subcutaneous (SC) doses
 Drug: MBX 1416 (Part B)
Repeated ascending subcutaneous (SC) doses of MBX 1416: 10mg, 30mg, 100mg
Placebo Comparator: Placebo Drug: Placebo
Single dose or repeated subcutaneous (SC) dose of placebo.
Experimental: MBX 1416 (Part C)
Single subcutaneous (SC) dose of MBX 1416, single dose of rosuvastatin and acetaminophen.
 Drug: MBX 1416 (Part C)
Single subcutaneous (SC) dose of MBX 1416 and the single dose of rosuvastatin and acetaminophen pharmacokinetics. The doses selected for MBX 1416 in Part C will not exceed a dose of 200mg.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events (AEs), Serious Adverse Events (SAEs) [ Time Frame: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C) ]
  2. Maximum Plasma Concentration (Cmax) [ Time Frame: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Part A/B/C Inclusion Criteria:

  1. Female and male adults, ages ≥ 18 and ≤ 65 years with a body mass index (BMI) ≥ 18 kg/m² to ≤ 30.0 kg/m² and fasting glucose < 100 mg/dL and HbA1c < 5.7%.
  2. Female subjects of childbearing potential (WOCBP) and male subjects must use highly effective contraception.

Part A/B/C Exclusion Criteria:

  1. Pregnant, lactating or intending to become pregnant during the study.
  2. Use of weight-lowering pharmacotherapy or participation in a clinical weight control study within the previous 3 months prior to the first dose of study drug.
  3. Presence of clinically significant ECG findings
  4. Subjects with a prior history of any serious adverse reaction, hypersensitivity or angioedema to GLP-1 receptor agonists, study drug or drug components.
  5. Abnormal laboratory results at Screening.
  6. History of renal disease or abnormal kidney function tests at Screening
  7. Presence of any clinically significant physical exam, ECG, or laboratory findings at screening.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06036784


Contacts
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Contact: Pavla Bednarek, MD 619-500-1836 pavla.bednarek@prosciento.com
Contact: Kirk Ways, MD, PhD 619-849-5388 kways@mbxbio.com

Locations
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United States, California
ProSciento CRU Recruiting
Chula Vista, California, United States, 91911
Contact: MD, PhD         
Contact: Carmen Flores    619-755-8301    carmen.flores@prosciento.com   
Sponsors and Collaborators
MBX Biosciences
ProSciento, Inc.
More Information
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Responsible Party: MBX Biosciences
ClinicalTrials.gov Identifier: NCT06036784    
Other Study ID Numbers: MBX-1P2001
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: February 22, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases