Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects

MBX Biosciences

Status and phase: Completed; Phase 1

Conditions: Postbariatric Hypoglycemia

Treatments: Drug: MBX 1416 (Part A); Drug: Placebo; Drug: MBX 1416 (Part C); Drug: MBX 1416 (Part B)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06036784

MBX-1P2001

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Part A/B/C Inclusion Criteria:

1. 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%.
2. Female subjects of childbearing potential (WOCBP) and male subjects must use highly effective contraception.

Part A/B/C Exclusion Criteria:

1. Pregnant, lactating or intending to become pregnant during the study.
2. 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.
3. Presence of clinically significant ECG findings
4. Subjects with a prior history of any serious adverse reaction, hypersensitivity or angioedema to GLP-1 receptor agonists, study drug or drug components.
5. Abnormal laboratory results at Screening.
6. History of renal disease or abnormal kidney function tests at Screening
7. Presence of any clinically significant physical exam, ECG, or laboratory findings at screening.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

69 participants in 4 patient groups, including a placebo group

MBX 1416 (Part A)

Experimental group

Description:

Single ascending subcutaneous (SC) doses

Treatment:

Drug: MBX 1416 (Part A)

MBX 1416 (Part B)

Experimental group

Description:

Repeated ascending subcutaneous (SC) doses

Treatment:

Drug: MBX 1416 (Part B)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

MBX 1416 (Part C)

Experimental group

Description:

Single subcutaneous (SC) dose of MBX 1416, single dose of rosuvastatin and acetaminophen.

Treatment:

Drug: MBX 1416 (Part C)