ERX1000 - Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Male and Female Subjects With Obesity
NCT04890873 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2023-10-24
Summary
The primary objective is to assess the safety and tolerability of single and multiple oral doses of ERX1000 in obese subjects.
Conditions
Interventions
- DRUG
-
ERX1000
ERX1000 powder provided for preparation of a 4 mg/10 mL oral suspension and 8 mg/10 mL oral suspension
- DRUG
-
A suspension containing magnesium hydroxide carbonate in polysorbate
Sponsors & Collaborators
-
ERX Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Irene Mirkin, MD · Labcorp Clinical Research Unit Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-17
- Primary Completion
- 2023-07-03
- Completion
- 2023-07-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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