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

Postbariatric Hypoglycemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036784
• Other study ID #: MBX-1P2001
• Status: Recruiting
• Phase: Phase 1
• Start date: September 18, 2023
• Est. completion date: October 17, 2024

Study information

• Verified date: February 2024
• Source: MBX Biosciences
• Contact: Pavla Bednarek, MD
• Phone: 619-500-1836
• Email: pavla.bednarek[@]prosciento.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: October 17, 2024
• Est. primary completion date: October 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoglycemia
• Postbariatric Hypoglycemia

Intervention

Drug:
• MBX 1416 (Part A)
Single Ascending subcutaneous (SC) dose of MBX 1416: 10mg, 30mg,100mg, 200mg
• MBX 1416 (Part B)
Repeated ascending subcutaneous (SC) doses of MBX 1416: 10mg, 30mg, 100mg
• Placebo
Single dose or repeated subcutaneous (SC) dose of 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.

Locations

Country	Name	City	State
United States	ProSciento CRU	Chula Vista	California

Sponsors (2)

Lead Sponsor	Collaborator
MBX Biosciences	ProSciento, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs), Serious Adverse Events (SAEs)		Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)
Primary	Maximum Plasma Concentration (Cmax)		Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)