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Trial record 1 of 1 for:    MBX 2109
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Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT05158335
Recruitment Status : Recruiting
First Posted : December 15, 2021
Last Update Posted : March 10, 2023
Sponsor:
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 of MBX 2109 in healthy volunteers.

This study includes 2 parts. Part A involves a single dose of MBX 2109 taken as a subcutaneous (SC) injection just under the skin. Part B involves repeat doses of MBX 2109 taken as a SC injection just under the skin. Each participant will enroll in only one part.


Condition or disease Intervention/treatment Phase
Healthy Drug: MBX 2109 (Part A) Drug: MBX 2109 (Part B) Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single and Multiple Ascending Doses of MBX 2109 in Healthy Participants
Actual Study Start Date : November 10, 2021
Estimated Primary Completion Date : June 8, 2023
Estimated Study Completion Date : June 8, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: MBX 2109 (Part A)
Single ascending SC doses
 Drug: MBX 2109 (Part A)
Single ascending SC dose of MBX 2109: 50 µg, 150 µg, 300 µg, 460 µg, 600 µg
Experimental: MBX 2109 (Part B)
Repeated ascending SC doses
 Drug: MBX 2109 (Part B)
Repeated ascending SC doses of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg
Placebo Comparator: Placebo Drug: Placebo
Single SC dose or repeated SC doses of placebo.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Outcome Measures [ Time Frame: Baseline through Day 40 (part A) or Day 60 (Part B) ]
    Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)


Secondary Outcome Measures :
  1. Secondary Outcome Measures 1 [ Time Frame: Baseline through Day 40 (part A) or Day 60 (Part B) ]
    Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of MBX 2109

  2. Secondary Outcome Measures 2 [ Time Frame: Baseline through Day 40 (part A) or Day 60 (Part B) ]
    Pharmacodynamics (PD): change from baseline in albumin corrected serum calcium


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men and women of non-child bearing potential
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy men and women (of nonchildbearing potential) between 20 and 60 years of age, inclusive.
  2. Body mass index between 20.0 and 32.0 kg/m2, inclusive.
  3. No clinically meaningful findings on physical examination, electrocardiogram, laboratory tests or vital signs
  4. Subject has been given signed informed consent

Exclusion Criteria:

  1. History of any significant illness or disorder
  2. Acute illness within 30 days of administration of first dose of study drug
  3. Positive screening result for HIV, hepatitis B or hepatitis C
  4. History of or current substance abuse (drug or alcohol) within past 1 year or positive test for drugs of abuse during screening
  5. Use of nicotine-containing or vaping products within 3 months prior to screening or check-in
  6. Use of cannabis within 45 days prior to check-in
  7. Donation of blood within 3 months prior to screening, plasma within 2 weeks prior to screening or platelets within 6 weeks prior to screening
  8. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within past 30 days
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): NCT05158335


Contacts
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Contact: Irene Mirkin, MD (608) 442-8200 Irene.Mirkin@labcorp.com

Locations
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United States, Texas
Labcorp Drug Development: Clinical Research Unit Recruiting
Dallas, Texas, United States, 75247
Contact: Jhande Gardiner    214-647-9399    Jhande.Gardiner@covance.com   
Contact: Marcy Davis    469-914-8327    Marcy.Davis@covance.com   
Principal Investigator: Abiodun Adefurin, MD, MSc         
United States, Wisconsin
Labcorp Drug Development: Clinical Research Unit Recruiting
Madison, Wisconsin, United States, 53704
Contact: Taylor Pinkerton, B.S.    608-210-5355    taylor.pinkerton@labcorp.com   
Contact: Moua Thao    (608) 442-8200    Moua.Thao@Labcorp.com   
Sponsors and Collaborators
MBX Biosciences
Investigators
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Study Director: Mary Jane Geiger, MD, PhD MBX Biosciences
More Information
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Responsible Party: MBX Biosciences
ClinicalTrials.gov Identifier: NCT05158335    
Other Study ID Numbers: MBX-2H1001
First Posted: December 15, 2021    Key Record Dates
Last Update Posted: March 10, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No