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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

Tracking Information
First Submitted Date  ICMJE August 28, 2023
First Posted Date  ICMJE September 14, 2023
Last Update Posted Date February 22, 2024
Actual Study Start Date  ICMJE September 18, 2023
Estimated Primary Completion Date October 17, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2024)
  • 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) ]
  • Maximum Plasma Concentration (Cmax) [ Time Frame: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2023)
  • Number of participants with adverse events (AEs), Serious Adverse Events (SAEs) [ Time Frame: Baseline through Day 29 (Part A) or Day 45 (Part B) ]
  • Maximum Plasma Concentration (Cmax) [ Time Frame: Baseline through Day 29 (Part A) or Day 45 (Part B) ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects
Official Title  ICMJE A Phase 1 Single and Multiple Ascending Dose and Drug Drug Interaction Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double Blind
Primary Purpose: Basic Science
Condition  ICMJE Postbariatric Hypoglycemia
Intervention  ICMJE
  • Drug: MBX 1416 (Part A)
    Single Ascending subcutaneous (SC) dose of MBX 1416: 10mg, 30mg,100mg, 200mg
  • Drug: MBX 1416 (Part B)
    Repeated ascending subcutaneous (SC) doses of MBX 1416: 10mg, 30mg, 100mg
  • Drug: Placebo
    Single dose or repeated subcutaneous (SC) dose of placebo.
  • 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.
Study Arms  ICMJE
  • Experimental: MBX 1416 (Part A)
    Single ascending subcutaneous (SC) doses
    Intervention: Drug: MBX 1416 (Part A)
  • Experimental: MBX 1416 (Part B)
    Repeated ascending subcutaneous (SC) doses
    Intervention: Drug: MBX 1416 (Part B)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: MBX 1416 (Part C)
    Single subcutaneous (SC) dose of MBX 1416, single dose of rosuvastatin and acetaminophen.
    Intervention: Drug: MBX 1416 (Part C)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2024)
84
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2023)
56
Estimated Study Completion Date  ICMJE October 17, 2024
Estimated Primary Completion Date October 17, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pavla Bednarek, MD 619-500-1836 pavla.bednarek@prosciento.com
Contact: Kirk Ways, MD, PhD 619-849-5388 kways@mbxbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06036784
Other Study ID Numbers  ICMJE MBX-1P2001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party MBX Biosciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE MBX Biosciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE ProSciento, Inc.
Investigators  ICMJE Not Provided
PRS Account MBX Biosciences
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP