First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study of Single Ascending Doses in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of PATAS
AdipoPharma LLC
Summary
The primary objective of this study is to evaluate safety and tolerability of single subcutaneous (SC) doses of PATAS in healthy subjects. The secondary objective of this study is to determine the pharmacokinetics (PK) of single SC doses of PATAS in healthy subjects.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Part 1: Single Ascending Dose Inclusion criteria 1. Healthy male and female subjects, 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Form (ICF); 2. Willing and able to give written informed consent for participation in the study prior to the initiation of any Screening or study-specific procedures; 3. Body mass index (BMI) within the range of 20.0 to 35.0 kg/m2, inclusive, at Screening; 4. In generally good health, as judged by the Investigator, based upon medical/surgical history and the results of physical examination, vital sign…
Interventions
- DrugPATAS Trifluoroacetate
A drug targeting the interaction between the ALMS1 protein and alpha-PKC
- DrugPlacebo
Excipient only formulation, without active compound
Locations (2)
- Medpace Clinical Pharmacology UnitCincinnati, Ohio
- Medpace Clinical Pharmaology UnitCincinnati, Ohio