A Phase 1, Randomized, Placebo-Controlled, Double-Blind First in Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DA-1726 in Participants With Obesity.
NeuroBo Pharmaceuticals Inc.
Summary
This is a First in Human study to evaluate the safety and tolerability of DA-1726 following single and multiple doses in participants with obesity, but otherwise healthy subjects.
Description
This is a Phase 1, randomized, placebo-controlled, double-blind, sequential parallel group study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in adult participants (aged 18 to 65 years) with obesity (BMI ≥30 - 45 kg/m2). DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Willing and able to provide informed consent prior to initiation of any study specific procedures/activities. 2. Males and females ≥18 to \<=65 years of age, at the time of signing informed consent, who have been diagnosed with obesity, defined by BMI. 3. Except for obesity, otherwise healthy or with stable, well controlled obesity-related conditions as determined by the investigator based on a medical evaluation including physical exam, medical history, laboratory tests, and ECGs. 4. Body mass index (BMI) ≥ 30.0 kg/m2 to 45.0 kg/m2 (Obesity to be confirmed by Caliper t…
Interventions
- DrugDA-1726
Active
- DrugPlacebo to DA-1726
Placebo
Location
- Clinical Pharmacology of Miami, LLCMiami, Florida