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

NCT01513967 | Completed Phase 1 Results DMC

• 1 other identifier: RGN-ADC-001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

This is a dual-centre, Phase I/IIa study, in healthy subjects and subjects with AD to investigate the safety, tolerability, cognitive, and behavioural effects of RPh201. The study will be divided into three parts: A, B, and C (NOT Performed)

Conditions

Healthy Volunteers; Moderate to Severe Alzheimer Patients

Keywords

Alzheimer,; dementia

Outcome Measures

Primary Outcomes (1)

• The Primary Objective: to Evaluate the Safety and Tolerability of RPh201 After Single and Multiple Rising Doses.

  Safety and tolerability following single and multiple ascending SC injection doses as assessed by Treatment-Emergent Adverse Events

  up to 1 month

Study Arms (12)

Part A, SAD Treatment 1

EXPERIMENTAL

RPh201 single dose (SAD Low Dose )

Drug: RPh201, botanical drug product

Part A, SAD Placebo 1

PLACEBO COMPARATOR

Placebo single dose (SAD Low Dose )

Drug: Placebo

Part A, SAD Treatment 2

EXPERIMENTAL

RPh201 single dose (SAD Mid Dose )

Drug: RPh201, botanical drug product

Part A, SAD Placebo 2

PLACEBO COMPARATOR

Placebo single dose (SAD Mid Dose )

Drug: Placebo

Part A, SAD Treatment 3

EXPERIMENTAL

RPh201 single dose (SAD High Dose )

Drug: RPh201, botanical drug product

Part A, SAD Placebo 3

PLACEBO COMPARATOR

Placebo single dose (SAD High Dose )

Drug: Placebo

Part B, MAD Treatment 1

EXPERIMENTAL

RPh201 multiple dose (MAD Low Dose )

Drug: RPh201, botanical drug product

Part B, MAD Placebo 1

PLACEBO COMPARATOR

Placebo multiple dose (MAD Low Dose )

Drug: Placebo

Part B, MAD Treatment 2

EXPERIMENTAL

RPh201 multiple dose (MAD Mid Dose )

Drug: RPh201, botanical drug product

Part B, MAD Placebo 2

PLACEBO COMPARATOR

Placebo multiple dose (MAD Mid Dose )

Drug: Placebo

Part B, MAD Treatment 3

EXPERIMENTAL

RPh201 multiple dose (MAD High Dose )

Drug: RPh201, botanical drug product

Part B, MAD Placebo 3

PLACEBO COMPARATOR

Placebo multiple dose (MAD High Dose )

Drug: Placebo

Interventions

RPh201, botanical drug product DRUG

SC administration at varying doses

Part A, SAD Treatment 1; Part A, SAD Treatment 2; Part A, SAD Treatment 3; Part B, MAD Treatment 1; Part B, MAD Treatment 2; Part B, MAD Treatment 3

Placebo DRUG

SC administration at varying doses

Part A, SAD Placebo 1; Part A, SAD Placebo 2; Part A, SAD Placebo 3; Part B, MAD Placebo 1; Part B, MAD Placebo 2; Part B, MAD Placebo 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy male or female subjects 18 to 65 years of age, inclusive
• body mass index (BMI) within the range of 18.0 to 33.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg at Screening
• female subjects of childbearing potential must be practicing abstinence or using and willing to continue using two medically acceptable form of birth control for at least 1 month prior to Screening (at least 3 months for oral and transdermal contraceptives) and for at least 1 month after the last study drug administration. Medically acceptable forms of contraception include oral or patch hormonal contraceptives, intrauterine device, progestin implant or injection, bilateral tubal ligation, or double-barrier (i.e., male condom in addition to a diaphragm or a contraceptive sponge).
• female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy/salpingo-oophorectomy (as determined by subject medical history)
• male subjects of reproductive potential with a partner(s) of childbearing potential, must be using and willing to continue to using two medically acceptable contraceptive precautions from Screening and for at least 1 month after the last study drug administration. Medically acceptable forms of contraception include abstinence, vasectomy, or male condom for subjects
• female subjects must have a negative pregnancy test
• able to speak, read, and understand English sufficiently to understand the nature of the study, to provide written informed consent, and to allow completion of all study assessments
• must understand and provide written informed consent prior to the initiation of any protocol-specific procedures
• must be willing and able to abide by all study requirements and restrictions

You may not qualify if:

• 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

Sponsors & Collaborators

• Regenera Pharma Ltd: lead
• Syneos Health: collaborator

Study Sites (2)

Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada

Location

Kendle Early Stage - Toronto

Toronto, Ontario, M5V 2T3, Canada

Location

Related Publications (1)

• Hazan Z, Adamsky K, Lucassen A, Levin LA. A First-in-Human Phase 1 Randomized Single and Multiple Ascending Dose Study of RPh201 in Healthy Volunteers. Clin Pharmacol Drug Dev. 2020 Apr;9(3):366-374. doi: 10.1002/cpdd.720. Epub 2019 Jun 28.

  PMID: 31250992 RESULT

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr Konstatin Adamsky
• Organization: Regenera Pharma Ltd

kostia@Regenerapharma.com

+972 8 9316306

Study Officials

• Janice Faulknor, MD

  Kendle Early Stage - Toronto

  PRINCIPAL INVESTIGATOR

• Sharon Cohen, MD

  Toronto Memory Program

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 20, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 23, 2020
• Results First Posted: March 23, 2020

Record last verified: 2020-03

Locations

CA (2)