A Randomized SAD and MAD Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease

current drug or alcohol dependence (excluding caffeine), based on self-report, including subjects who have been in a drug rehabilitation program

current smoker or a history of using tobacco products within 3 months prior to Screening

clinically significant abnormalities on physical examination, medical history, 12-lead ECG (i.e., QTc \> 440 for male subjects and \> 450 for female subjects), vital signs, or laboratory values, as judged by the investigator or designee

history or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results

use of a non-prescription drug within 7 days prior to the first drug administration. Subjects who have taken over-the-counter medication may still be entered into the study, if in the opinion of the investigator or designee, the medication received will not interfere with the study procedures or data integrity or compromise the safety of the subject

use of any prescription medications, recreational drugs, or natural health products (except vitamin or mineral supplements, acceptable forms of birth control, and hormone replacement) within 14 days prior to first drug administration or throughout the study, unless in the opinion of the investigator or designee, the product will not interfere with the study procedures or data integrity or compromise the safety of the subject

positive urine drug screen

positive breath alcohol test. If a subject presents with positive breath alcohol test, the subject may be rescheduled at the discretion of the investigator or designee

female subjects who are currently pregnant or lactating or who are planning to become pregnant within 60 days of last study drug administration

history of allergy or hypersensitivity to mastic or related drugs (e.g., mastic gum, mastic resin, Chios mastic powder, retsina wine, Mastic Gum 500, Mastic Gum Elma 50, Nutricology Mastic Gum)

history of allergy or hypersensitivity to cottonseed oil

positive for Hepatitis B, Hepatitis C, or HIV

current or pending legal charges or currently on probation

treatment with any investigational drug within 30 days prior to first drug administration in the treatment phase

a subject who, in the opinion of the investigator or designee, is not considered to be suitable and is unlikely to comply with the study protocol for any reason

For PART C (subjects with Alzheimer's Disease)

diagnosis or history of other dementia or neurodegenerative disorders causing cognitive impairment (e.g., Parkinson's disease, Lewy body disease, Fronto-temporal Dementia, alcohol and drug abuse, Traumatic Brain Injury).

subjects receiving immunosuppressants, tricyclic anti-depressants, anticoagulants, or chemotherapeutic agents

hypertension not adequately controlled, per investigator's judgment

poorly controlled Type 1 and/or Type 2 diabetes, per investigator's judgment

women of child bearing potential who are not using an effective method of birth control

any other medical condition or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or that may interfere with the interpretation of study results, and that, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

A Randomized SAD and MAD Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease

What this study is about

A Randomized SAD and MAD Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease

What this study is about