Postbariatric HypoglycemiaPhase 1NCT06036784
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects
A Phase 1 study testing MBX 1416 (Part A), MBX 1416 (Part B) and MBX 1416 (Part C) in people with Postbariatric Hypoglycemia, run by MBX Biosciences at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postbariatric Hypoglycemia
- What is being tested?
- MBX 1416 (Part A), MBX 1416 (Part B) and MBX 1416 (Part C)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to 5 Dec 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Part A/B/C Inclusion Criteria:
- 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%.
- Female subjects of childbearing potential (WOCBP) and male subjects must use highly effective contraception.
Part A/B/C Exclusion Criteria:
- Pregnant, lactating or intending to become pregnant during the study.
- 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.
- Presence of clinically significant ECG findings
- Subjects with a prior history of any serious adverse reaction, hypersensitivity or angioedema to GLP-1 receptor agonists, study drug or drug components.
- Abnormal laboratory results at Screening.
- History of renal disease or abnormal kidney function tests at Screening
- Presence of any clinically significant physical exam, ECG, or laboratory findings at screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
MBX Biosciences Investigational Site
Chula Vista, California, 91911
About this study
Official title: A Phase 1 Single and Multiple Ascending Dose and Drug Drug Interaction Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
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.
- Conditions
- Postbariatric Hypoglycemia
- Being tested
- MBX 1416 (Part A), MBX 1416 (Part B), Placebo, MBX 1416 (Part C)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBX 1416 (Part A)Drug
Single Ascending subcutaneous (SC) dose of MBX 1416: 10mg, 30mg,100mg, 200mg
MBX 1416 (Part B)Drug
Repeated ascending subcutaneous (SC) doses of MBX 1416: 10mg, 30mg, 100mg
PlaceboDrug
Single dose or repeated subcutaneous (SC) dose of placebo.
MBX 1416 (Part C)Drug
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 group | Role | What they receive |
|---|---|---|
| MBX 1416 (Part A) | Experimental | Single ascending subcutaneous (SC) doses Receives: Drug: MBX 1416 (Part A) |
| MBX 1416 (Part B) | Experimental | Repeated ascending subcutaneous (SC) doses Receives: Drug: MBX 1416 (Part B) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| MBX 1416 (Part C) | Experimental | Single subcutaneous (SC) dose of MBX 1416, single dose of rosuvastatin and acetaminophen. Receives: Drug: MBX 1416 (Part C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs), Serious Adverse Events (SAEs)
Measured: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)
Maximum Plasma Concentration (Cmax)
Measured: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start18 Sep 2023
- Primary completion14 Nov 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postbariatric HypoglycemiaStudies 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- MBX Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ProSciento, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036784
- Sponsor's protocol ID
- MBX-1P2001
- Status last verified
- Dec 2024
- First submitted
- 28 Aug 2023
- Last updated
- 12 Dec 2024
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single and Multiple Ascending Dose and Drug Drug Interaction Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
- ClinicalTrials.gov ID
- NCT06036784
- Acronym / sponsor ID
- MBX-1P2001
- Conditions
- Postbariatric Hypoglycemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- MBX BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- ProSciento, Inc.
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 14 Sep 2023 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MBX 1416 (Part A) | Experimental | Drug: MBX 1416 (Part A)Single ascending subcutaneous (SC) doses |
| MBX 1416 (Part B) | Experimental | Drug: MBX 1416 (Part B)Repeated ascending subcutaneous (SC) doses |
| Placebo | Placebo comparator | Drug: Placebo |
| MBX 1416 (Part C) | Experimental | Drug: MBX 1416 (Part C)Single subcutaneous (SC) dose of MBX 1416, single dose of rosuvastatin and acetaminophen. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 1416 (Part A)Single Ascending subcutaneous (SC) dose of MBX 1416: 10mg, 30mg,100mg, 200mg | Drug | MBX 1416 (Part A) |
| MBX 1416 (Part B)Repeated ascending subcutaneous (SC) doses of MBX 1416: 10mg, 30mg, 100mg | Drug | MBX 1416 (Part B) |
| PlaceboSingle dose or repeated subcutaneous (SC) dose of placebo. | Drug | Placebo |
| 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. | Drug | MBX 1416 (Part C) |
Primary outcome
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)
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 12 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 1416 (Part A), MBX 1416 (Part B) and MBX 1416 (Part C) in people with Postbariatric Hypoglycemia, run by MBX Biosciences at 1 site 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?
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 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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)). The study lists 2 primary outcomes in all. 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 12 Dec 2024.