Healthy
Conditions
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.
Interventions
DRUGMBX 2109 (Part A)
Single ascending SC dose of MBX 2109: 50 µg, 150 µg, 300 µg, 460 µg, 600 µg
DRUGMBX 2109 (Part B)
Repeated ascending SC doses of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg
DRUGPlacebo
Single SC dose or repeated SC doses of placebo.
Sponsors
MBX Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measures | Baseline through Day 40 (part A) or Day 60 (Part B) | Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measures 1 | Baseline through Day 40 (part A) or Day 60 (Part B) | Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of MBX 2109 |
| Secondary Outcome Measures 2 | Baseline through Day 40 (part A) or Day 60 (Part B) | Pharmacodynamics (PD): change from baseline in albumin corrected serum calcium |
Countries
United States
Outcome results
None listed