Healthy VolunteersPhase 1/2NCT01513967
A Randomized SAD and MAD Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease
A Phase 1/2 study testing RPh201, botanical drug product in people with Healthy Volunteers and Moderate to Severe Alzheimer Patients, run by Regenera Pharma Ltd at 2 sites in Canada.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Moderate to Severe Alzheimer Patients
- What is being tested?
- RPh201, botanical drug product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2012to Jun 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
- males and females ages ≥ 55 years of age at Screening visit
- diagnosis of AD, consistent with criteria from both the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Criteria for Probable AD and Diagnostic and Statistical Manual of Mental Disorders - IV TR (DSM-IV TR) Criteria for Dementia of the Alzheimer's Type
- Mini-Mental Status Evaluation (MMSE) score of 5-15, inclusive, at Screening visit
- Rosen-Modified Hachninski Ischemia score of ≤ 4 at Screening visit
- subjects and caregivers must be able to read, write, and speak the language in which psychometric tests are provided with acceptable visual and auditory acuity
- subject must have a reliable informant (caregiver) to provide collateral history and who will facilitate the subject's full participation in the study
- subject and caregivers must provide written informed consent and be willing to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
- subjects may continue on background cholinesterase inhibitor and/or memantine
- subjects must be in satisfactory good health, in the opinion of the investigator, based on medical history, physical examination, vital signs, 12-lead ECG, and laboratory tests
- magnetic resonance imaging (MRI) or computed tomography (CT) within 12 months of Screening visit consistent with a diagnosis of Probable AD without any other clinically significant findings
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Toronto Memory Program
Toronto, Ontario, M3B 2S7
Kendle Early Stage - Toronto
Toronto, Ontario, M5V 2T3
About this study
Official title: A Randomized Single and Multiple Dose Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease
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)
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of RPh201 after single and multiple ascending doses. This study is designed with sufficient time in between dose escalations to allow for an interim analysis of safety and tolerability data as this is considered the safest approach to assess the effects of a compound with an undefined mechanism and therapeutic target.
This protocol is written with some flexibility to accommodate the inherent dynamic nature of Phase I clinical studies. Modifications to the dose, dosing regimen, and/or clinical or laboratory procedures currently outlined below may be required to achieve the scientific goals of the study objectives and/or to ensure appropriate safety monitoring of the study subjects. Interim safety analyses will guide dose escalation/reduction in the trial.
- Being tested
- RPh201, botanical drug product, Placebo
- Keywords
- Alzheimer,, dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPh201, botanical drug productDrug
SC administration at varying doses
PlaceboDrug
SC administration at varying doses
| Study group | Role | What they receive |
|---|---|---|
| Part A, SAD Treatment 1 | Experimental | RPh201 single dose (SAD Low Dose ) Receives: Drug: RPh201, botanical drug product |
| Part A, SAD Placebo 1 | Placebo comparator | Placebo single dose (SAD Low Dose ) Receives: Drug: Placebo |
| Part A, SAD Treatment 2 | Experimental | RPh201 single dose (SAD Mid Dose ) Receives: Drug: RPh201, botanical drug product |
| Part A, SAD Placebo 2 | Placebo comparator | Placebo single dose (SAD Mid Dose ) Receives: Drug: Placebo |
| Part A, SAD Treatment 3 | Experimental | RPh201 single dose (SAD High Dose ) Receives: Drug: RPh201, botanical drug product |
| Part A, SAD Placebo 3 | Placebo comparator | Placebo single dose (SAD High Dose ) Receives: Drug: Placebo |
| Part B, MAD Treatment 1 | Experimental | RPh201 multiple dose (MAD Low Dose ) Receives: Drug: RPh201, botanical drug product |
| Part B, MAD Placebo 1 | Placebo comparator | Placebo multiple dose (MAD Low Dose ) Receives: Drug: Placebo |
| Part B, MAD Treatment 2 | Experimental | RPh201 multiple dose (MAD Mid Dose ) Receives: Drug: RPh201, botanical drug product |
| Part B, MAD Placebo 2 | Placebo comparator | Placebo multiple dose (MAD Mid Dose ) Receives: Drug: Placebo |
| Part B, MAD Treatment 3 | Experimental | RPh201 multiple dose (MAD High Dose ) Receives: Drug: RPh201, botanical drug product |
| Part B, MAD Placebo 3 | Placebo comparator | Placebo multiple dose (MAD High Dose ) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenera Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Janice Faulknor, MD, Principal investigator, Kendle Early Stage - TorontoSharon Cohen, MD, Principal investigator, Toronto Memory Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513967
- Sponsor's protocol ID
- RGN-ADC-001
- Status last verified
- Mar 2020
- First submitted
- 17 Jan 2012
- Last updated
- 23 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 31250992
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single and Multiple Dose Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01513967
- Acronym / sponsor ID
- RGN-ADC-001
- Keywords
- Alzheimer,, dementia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Regenera Pharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- Jan 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of RPh201 after single and multiple ascending doses. This study is designed with sufficient time in between dose escalations to allow for an interim analysis of safety and tolerability data as this is considered the safest approach to assess the effects of a compound with an undefined mechanism and therapeutic target.
This protocol is written with some flexibility to accommodate the inherent dynamic nature of Phase I clinical studies. Modifications to the dose, dosing regimen, and/or clinical or laboratory procedures currently outlined below may be required to achieve the scientific goals of the study objectives and/or to ensure appropriate safety monitoring of the study subjects. Interim safety analyses will guide dose escalation/reduction in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part A, SAD Treatment 1 | Experimental | Drug: RPh201, botanical drug productRPh201 single dose (SAD Low Dose ) |
| Part A, SAD Placebo 1 | Placebo comparator | Drug: PlaceboPlacebo single dose (SAD Low Dose ) |
| Part A, SAD Treatment 2 | Experimental | Drug: RPh201, botanical drug productRPh201 single dose (SAD Mid Dose ) |
| Part A, SAD Placebo 2 | Placebo comparator | Drug: PlaceboPlacebo single dose (SAD Mid Dose ) |
| Part A, SAD Treatment 3 | Experimental | Drug: RPh201, botanical drug productRPh201 single dose (SAD High Dose ) |
| Part A, SAD Placebo 3 | Placebo comparator | Drug: PlaceboPlacebo single dose (SAD High Dose ) |
| Part B, MAD Treatment 1 | Experimental | Drug: RPh201, botanical drug productRPh201 multiple dose (MAD Low Dose ) |
| Part B, MAD Placebo 1 | Placebo comparator | Drug: PlaceboPlacebo multiple dose (MAD Low Dose ) |
| Part B, MAD Treatment 2 | Experimental | Drug: RPh201, botanical drug productRPh201 multiple dose (MAD Mid Dose ) |
| Part B, MAD Placebo 2 | Placebo comparator | Drug: PlaceboPlacebo multiple dose (MAD Mid Dose ) |
| Part B, MAD Treatment 3 | Experimental | Drug: RPh201, botanical drug productRPh201 multiple dose (MAD High Dose ) |
| Part B, MAD Placebo 3 | Placebo comparator | Drug: PlaceboPlacebo multiple dose (MAD High Dose ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPh201, botanical drug productSC administration at varying doses | Drug | 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 |
| PlaceboSC administration at varying doses | Drug | 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 |
Primary outcome
The Primary Objective: to Evaluate the Safety and Tolerability of RPh201 After Single and Multiple Rising Doses.
Time frame: up to 1 month
Safety and tolerability following single and multiple ascending SC injection doses as assessed by Treatment-Emergent Adverse Events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31250992Hazan 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.
Related trials for Healthy Volunteers
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Faulknor, MD principal investigator
Kendle Early Stage - Toronto
Sharon Cohen, MD principal investigator
Toronto Memory Program
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RPh201, botanical drug product in people with Healthy Volunteers and Moderate to Severe Alzheimer Patients, run by Regenera Pharma Ltd at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Objective: to Evaluate the Safety and Tolerability of RPh201 After Single and Multiple Rising Doses. (time frame: up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01513967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.