Healthy VolunteerPhase 1NCT04158453
Safety, Blood Levels and Effects of AUT00201
A Phase 1 study testing AUT00201 in people with Healthy Volunteer, run by Autifony Therapeutics Limited at 1 site in United Kingdom.
Trial summary
The study medicine is a potential future treatment for schizophrenia, an illness that affects the way that people think, feel or behave. It is not clear what causes schizophrenia, but it's been linked to chemical imbalance in the brain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- AUT00201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Oct 2019to 24 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normotensive male (all groups except Part A2) or female (Part A2 only) volunteers
- Must have body mass index (BMI) of 18.0-31.0 kg/m2
- Must be healthy based on clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
- Must be able to give fully informed written consent.
Who cannot join
- History or presence of
- Epilepsy
- Severe head injury, or any other chronic neurological condition or any psychiatric disorder
- Abnormal screening EEG (Part A1 and Part B only)
- Positive tests for hepatitis B \& C, HIV
- Severe adverse reaction to any drug
Show all 19Show fewer
- Sensitivity to trial medication
- Drug or alcohol abuse
- Use of over-the-counter medication within previous 7 days (with the exception of Paracetamol [acetaminophen])
- Prescribed medication during previous 28 days
- Participation in other clinical trials of unlicensed medicines
- Loss of more than 400 mL blood, within the previous 3 months
- Vital signs or QTcF interval outside the acceptable range
- Clinically relevant abnormal findings at the screening assessment
- Acute or chronic illness
- Clinically relevant abnormal medical history or concurrent medical condition
- Positive result for suicidal ideation or behaviour using the Colombia suicide severity rating scale (C-SSRS)
- Possibility that volunteer will not cooperate
- Pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Single and Repeated Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AUT00201 in Healthy Male and Female Volunteers
The study medicine is a potential future treatment for schizophrenia, an illness that affects the way that people think, feel or behave. It is not clear what causes schizophrenia, but it's been linked to chemical imbalance in the brain. It is hoped that the study medicine will activate specific sites in the brain to help correct that imbalance. Current treatments for schizophrenia don't work very well and can cause unpleasant side effects. It is hoped that the study medicine will work better, and have fewer side effects than existing medicines.
In this 2 part study (Part A: up to 40 healthy male subjects and up to 8 healthy female subjects, Part B: up to 32 healthy male subjects) the primary aim is to assess how safe the study medicine is in healthy men and women.
Read more
This study will be in 2 parts, as follows:
Part A will assess single doses of AUT00201 and Part B will assess multiple doses. Part A will be divided into 3 sub-parts: Part A1 will assess single ascending doses in healthy men, Part A2 will assess single ascending doses in healthy women, and Part A3 will assess the effect of food on the PK of AUT00201 in healthy men.
A pharmaceutical company, Autifony Therapeutics Limited, is funding the study. The study will take place at 1 centre in London.
- Conditions
- Healthy Volunteer
- Being tested
- AUT00201, Placebo
- Keywords
- Healthy Volunteer, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUT00201Drug
Oral dose of AUT00201
PlaceboDrug
Oral dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| AUT00201 | Active comparator | Not described Receives: Drug: AUT00201 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects with treatment-related adverse events
Measured: Study Duration (2 weeks post last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start10 Oct 2019
- Primary completion14 Dec 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autifony Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158453
- Sponsor's protocol ID
- AUT011201
- Status last verified
- Jan 2021
- First submitted
- 7 Nov 2019
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Single and Repeated Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AUT00201 in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT04158453
- Acronym / sponsor ID
- AUT011201
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Autifony Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study medicine is a potential future treatment for schizophrenia, an illness that affects the way that people think, feel or behave. It is not clear what causes schizophrenia, but it's been linked to chemical imbalance in the brain. It is hoped that the study medicine will activate specific sites in the brain to help correct that imbalance. Current treatments for schizophrenia don't work very well and can cause unpleasant side effects. It is hoped that the study medicine will work better, and have fewer side effects than existing medicines.
In this 2 part study (Part A: up to 40 healthy male subjects and up to 8 healthy female subjects, Part B: up to 32 healthy male subjects) the primary aim is to assess how safe the study medicine is in healthy men and women.
This study will be in 2 parts, as follows:
Part A will assess single doses of AUT00201 and Part B will assess multiple doses. Part A will be divided into 3 sub-parts: Part A1 will assess single ascending doses in healthy men, Part A2 will assess single ascending doses in healthy women, and Part A3 will assess the effect of food on the PK of AUT00201 in healthy men.
A pharmaceutical company, Autifony Therapeutics Limited, is funding the study. The study will take place at 1 centre in London.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AUT00201 | Active comparator | Drug: AUT00201 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Normotensive male (all groups except Part A2) or female (Part A2 only) volunteers
- Must have body mass index (BMI) of 18.0-31.0 kg/m2
- Must be healthy based on clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
- Must be able to give fully informed written consent.
Key exclusion criteria (19 listed)
- History or presence of
- Epilepsy
- Severe head injury, or any other chronic neurological condition or any psychiatric disorder
- Abnormal screening EEG (Part A1 and Part B only)
- Positive tests for hepatitis B \& C, HIV
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 |
|---|---|---|
| AUT00201Oral dose of AUT00201 | Drug | AUT00201 |
| PlaceboOral dose of placebo | Drug | Placebo |
Primary outcome
Percent of subjects with treatment-related adverse events
Time frame: Study Duration (2 weeks post last dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AUT00201 in people with Healthy Volunteer, run by Autifony Therapeutics Limited at 1 site in United Kingdom.
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 4 inclusion and 19 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 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent of subjects with treatment-related adverse events (time frame: Study Duration (2 weeks post last dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2021.