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OpenTrials
Completed

NCT Number: NCT05158335

Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects

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.

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Key information

Conditions

Healthy

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Labcorp Drug Development: Clinical Research Unit, Dallas, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

MBX 2109 (Part A)

Drug

Single ascending SC dose of MBX 2109: 50 µg, 150 µg, 300 µg, 460 µg, 600 µg

MBX 2109 (Part B)

Drug

Repeated ascending SC doses of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg

Placebo

Drug

Single SC dose or repeated SC doses of placebo.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

MBX Biosciences

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 15, 2021
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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