Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05158335 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects
A Phase 1 study of Healthy, sponsored by MBX Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
- 2
- Study locations
NCT05158335: Completed Phase 1 study of Healthy, sponsored by MBX Biosciences.
NCT05158335 is a Phase 1 study of Healthy that has completed, run by MBX Biosciences. The registered enrollment target is 76 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05158335, a Phase 1 study of Healthy, has completed, sponsored by MBX Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MBX 2109 (Part A)
- DRUG MBX 2109 (Part B)
Study Locations (2)
Texas
- Labcorp Drug Development: Clinical Research Unit - Dallas
Wisconsin
- Labcorp Drug Development: Clinical Research Unit - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2021-11-10 |
| Est. Completion | 2023-06-20 |
| Phase | Phase 1 |
What the finished NCT05158335 record still lists
NCT05158335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05158335 reports a single indexed study location in Texas, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05158335 about?
NCT05158335 is a clinical study titled "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...
What is the current status of trial NCT05158335?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2021-11-10. Estimated completion is 2023-06-20.
What conditions does trial NCT05158335 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT05158335?
The interventions under investigation include: Placebo (DRUG), MBX 2109 (Part A) (DRUG), MBX 2109 (Part B) (DRUG).
Who is sponsoring clinical trial NCT05158335?
This trial is sponsored by MBX Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05158335 being conducted?
This trial has 2 study locations across Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05158335's enrollment target sits among peer trials
76 295th of 1090 higher than 792 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
RECRUITING · Phase 1
-
A Study of LY3867070 in Healthy Participants
RECRUITING · Phase 1
-
A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.
RECRUITING · Phase 1
-
Evaluate the Pharmacokinetics, Safety, and Tolerability of NSHO-101 in Healthy Participants
RECRUITING · Phase 1
-
Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Supplementation on Myocardial Glucose Suppression and Timing to Achieve a State of Ketosis Using FDG PET/CT Serial Imaging
RECRUITING · Phase 1
-
A Study of V118E in Healthy Participants (V118E-003)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02615184 · 76 participants · Phase 2
A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old
- NCT02821741 · 76 participants · NA
Effects of External Ear Stimulation on Pain Perception and Mood
- NCT03019757 · 76 participants
Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
- NCT03353584 · 76 participants · NA
Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI