HealthyPhase 1NCT05158335
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects
A Phase 1 study testing MBX 2109 (Part A) and MBX 2109 (Part B) in people with Healthy, run by MBX Biosciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MBX 2109 (Part A) and MBX 2109 (Part B)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2021to 20 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Labcorp Drug Development: Clinical Research Unit
Dallas, Texas, 75247
Labcorp Drug Development: Clinical Research Unit
Madison, Wisconsin, 53704
About this study
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
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.
- Conditions
- Healthy
- Being tested
- MBX 2109 (Part A), MBX 2109 (Part B), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDrug
Single SC dose or repeated SC doses of placebo.
| Study group | Role | What they receive |
|---|---|---|
| MBX 2109 (Part A) | Experimental | Single ascending SC doses Receives: Drug: MBX 2109 (Part A) |
| MBX 2109 (Part B) | Experimental | Repeated ascending SC doses Receives: Drug: MBX 2109 (Part B) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measures
Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)
Measured: Baseline through Day 40 (part A) or Day 60 (Part B)
Secondary outcomes (2)
Secondary Outcome Measures 1
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of MBX 2109
Measured: Baseline through Day 40 (part A) or Day 60 (Part B)
Secondary Outcome Measures 2
Pharmacodynamics (PD): change from baseline in albumin corrected serum calcium
Measured: Baseline through Day 40 (part A) or Day 60 (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start10 Nov 2021
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- MBX Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Jane Geiger, MD, PhD, Study director, MBX Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158335
- Sponsor's protocol ID
- MBX-2H1001
- Status last verified
- Aug 2023
- First submitted
- 2 Dec 2021
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05158335
- Acronym / sponsor ID
- MBX-2H1001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- MBX BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MBX 2109 (Part A) | Experimental | Drug: MBX 2109 (Part A)Single ascending SC doses |
| MBX 2109 (Part B) | Experimental | Drug: MBX 2109 (Part B)Repeated ascending SC doses |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBX 2109 (Part A)Single ascending SC dose of MBX 2109: 50 µg, 150 µg, 300 µg, 460 µg, 600 µg | Drug | MBX 2109 (Part A) |
| MBX 2109 (Part B)Repeated ascending SC doses of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg | Drug | MBX 2109 (Part B) |
| PlaceboSingle SC dose or repeated SC doses of placebo. | Drug | Placebo |
Primary outcome
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)
2 secondary outcomes
Secondary Outcome Measures 1
Time frame: Baseline through Day 40 (part A) or Day 60 (Part B)
Secondary Outcome Measures 2
Time frame: Baseline through Day 40 (part A) or Day 60 (Part B)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Jane Geiger, MD, PhD study director
MBX Biosciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MBX 2109 (Part A) and MBX 2109 (Part B) in people with Healthy, run by MBX Biosciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measures (time frame: Baseline through Day 40 (part A) or Day 60 (Part B)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.