This was a double blind, randomized, placebo controlled, single and multiple IV dosestudy conducted in 2 parts, single ascending dose and multiple ascending doses parts. Theprincipal aim of this study was to obtain safety and tolerability data when PA-001 isadministered IV as single and multiple doses to healthy subjects. This information,together with the PK data, will help establish the doses and dosing regimen suitable forfuture studies in patients. The study also investigated the effects of age on the PK ofPA-001 prior to patient studies.
Not Provided
Drug: PA-001
PA-001 or Placebo was infused via IV in accordance with a randomized schedule, after a
fast of at least 10 hours
Inclusion Criteria:
- Groups of healthy subjects: Males or females, of any race, between 18 and 65 years
of age, inclusive.
- Group(s) of elderly subjects: Males or females, of any race, > 65 years of age.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- In good health, or have stable, chronic, non life threatening medical conditions,
determined by no clinically significant findings
- Females will not be pregnant or lactating, and females of childbearing potential and
males will agree to use contraception.
- Able to comprehend and willing to sign an ICF and to abide by the study
restrictions.
Exclusion Criteria:
- Significant history or clinical manifestation of any metabolic, allergic,
dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,
gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
that, in the opinion of the investigator (or designee), could impact subject safety
or the objectives of the study.
- Have signs and symptoms of any other liver disease, except nonalcoholic fatty liver
disease, or any of the following, as determined from clinical laboratory
evaluations:
- History of significant hypersensitivity, intolerance, or allergy to any drug
compound, food, or other substance, as determined by the investigator (or designee).
- Positive hepatitis panel or positive human immunodeficiency virus test.
- Positive SARS-CoV-2 test at screening or check in.
- Have signs which shows something was not right in the ECG or history of additional
risk factors for torsades de pointes.
- Administration of a COVID 19 vaccine in the past 30 days prior to dosing.
- Participation in a clinical study involving administration of an investigational
drug (new chemical entity) in the past 30 days or 5 half lives of that drug prior to
dosing, whichever is longer.
- Subjects who, in the opinion of the investigator (or designee), should not
participate in this study.
Fortrea Clinical Research Unit Inc.
Dallas, Texas, United States
Masato Murakami, MD, Study Director
PeptiAID Inc.