HealthyPhase 1NCT05260658
Safety and Tolerability of CFTX-1554 in Healthy Subjects
A Phase 1 study testing CFTX-1554 in people with Healthy, run by Confo Therapeutics at 1 site in Netherlands.
Trial summary
The study will consist of 2 parts, i.e. a single ascending dose part with integrated food effect assessment and assessment of relative bioavailability (Part A), and a multiple ascending dose part (Part B). Part A will have a randomized, double-blind, placebo-controlled design. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CFTX-1554
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Feb 2022to 10 Feb 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index 18.0 to 30.0 kg/m2
- Females may be of childbearing potential but not pregnant or lactating, or of nonchildbearing potential; all females will be required to have a negative serum pregnancy test conducted at screening, (each) admission, and follow-up.
- Female subjects of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception from at least 4 weeks prior to first administration of study drug until 90 days after the follow up visit.
- Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit.
- All prescribed medication must have been stopped at least 30 days prior to first admission to the clinical research center.
- All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications must have been stopped at least 14 days prior to first admission to the clinical research center.
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- Ability and willingness to abstain from alcohol from 48 hours before screening and first admission to the clinical research center.
- Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) and grapefruit (juice) from 48 hours before first admission to the clinical research center.
- Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
- Willing and able to sign the Informed Consent Form.
Who cannot join
- Previous participation in the current study
- History of relevant drug and/or food allergies
- Allergy or hypersensitivity to active ingredient or excipients of the study drug
- Using nicotine-containing products within 60 days prior to the first study drug administration
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 1 year before screening
- Positive drug and alcohol screen in urine (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, nicotine metabolites [cotinine], and alcohol) at screening or at one of the admissions to the clinical research center
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- Average intake of >24 units of alcohol/week
- Positive screen for hepatitis B surface antigen, hepatitis C virus antibodies, or human immunodeficiency virus 1 and 2 antibodies
- Participation in a drug study within 30 days prior to the first study drug administration in the current study (counting from the follow-up visit to the screening visit). Participation in ≥4 other drug studies in the 12 months before the first study drug administration in the current study
- Donation or loss of >450 mL of blood within 60 days pribefore the first study drug administration. Donation or loss of >1.5 L of blood in male subjects) or >1.0 L of blood in female subjects in the 10 months before the first study drug administration in the current study.
- Significant and/or acute illness within 5 days before the first study drug administration that may impact safety assessments, in the opinion of the Investigator.
- Unwillingness to consume the Food and Drug Administration (FDA) breakfast or intolerance to any of the ingredients of the FDA breakfast (Cohort A5 only)
- Vaccination against SARS-CoV-2 planned between 2 weeks before first admission and follow-up.
- Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -1, or any known contact with a person who tested positive for SARS-CoV-2 or with a COVID 19 patient within 2 weeks before admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of CFTX-1554 in Healthy Subjects, With Comparison of Intake of CFTX-1554 as Liquid Formulation and as Capsule, and After a High-fat Breakfast Versus Fasted
The study will consist of 2 parts, i.e. a single ascending dose part with integrated food effect assessment and assessment of relative bioavailability (Part A), and a multiple ascending dose part (Part B).
Part A will have a randomized, double-blind, placebo-controlled design. Subjects will receive single ascending doses of CFTX-1554 or placebo (as liquid formulation under fasted condition) in 7 subsequent cohorts. Drug intake under fed conditions, and as capsule under fasted conditions and under fed conditions (Periods 2 to 4), compared to liquid formulation under fasted conditions (Period 1) (1 single dose level only) will be assessed.
Part B will have a randomized, double-blind, placebo-controlled design, assessing multiple ascending oral doses of CFTX-1554 or placebo in 4 subsequent cohorts.
- Conditions
- Healthy
- Being tested
- CFTX-1554, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CFTX-1554Drug
CFTX-1554 is a new chemical entity that binds to the angiotensin II type 2 receptor (AT2R).
PlaceboDrug
CFTX-1554 matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A: CFTX-1554 Single Ascending Dose (SAD) | Experimental | Up to 7 dose levels with CFTX-1554 administered as oral liquid formulation under fasted conditions (at 1 single dose level only, drug intake under fed conditions, and as capsule under fasted conditions and under fed conditions, will be assessed) Receives: Drug: CFTX-1554 |
| Part A placebo | Placebo comparator | Single placebo administration in study Part A Receives: Drug: Placebo |
| Part B: CFTX-1554 Multiple Ascending Dose (MAD) | Experimental | Up to 4 dose levels with CFTX-1554 in Part B. Doses and dosing frequency will be decided based on the results of study Part A. Receives: Drug: CFTX-1554 |
| Part B placebo | Placebo comparator | Multiple placebo administration in study Part B Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Number of Participants With Adverse Events Following Oral Administration of CFTX-1554 in SAD (Part A) and MAD (Part B)
Measured: Day -1 through Day 13 (Single Ascending Dose study part) or Day 26 (Multiple Ascending Dose study part)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start9 Feb 2022
- Primary completion10 Feb 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Confo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paolo Vicini, PhD, Study chair, Confo Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260658
- Sponsor's protocol ID
- CFTX1554-C101
- Other IDs
- 2021-006368-26
- Status last verified
- Sep 2023
- First submitted
- 18 Feb 2022
- Last updated
- 5 Sep 2023
- 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 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of CFTX-1554 in Healthy Subjects, With Comparison of Intake of CFTX-1554 as Liquid Formulation and as Capsule, and After a High-fat Breakfast Versus Fasted
- ClinicalTrials.gov ID
- NCT05260658
- Acronym / sponsor ID
- CFTX1554-C101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Confo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 2 Mar 2022 (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 will consist of 2 parts, i.e. a single ascending dose part with integrated food effect assessment and assessment of relative bioavailability (Part A), and a multiple ascending dose part (Part B).
Part A will have a randomized, double-blind, placebo-controlled design. Subjects will receive single ascending doses of CFTX-1554 or placebo (as liquid formulation under fasted condition) in 7 subsequent cohorts. Drug intake under fed conditions, and as capsule under fasted conditions and under fed conditions (Periods 2 to 4), compared to liquid formulation under fasted conditions (Period 1) (1 single dose level only) will be assessed.
Part B will have a randomized, double-blind, placebo-controlled design, assessing multiple ascending oral doses of CFTX-1554 or placebo in 4 subsequent cohorts.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: CFTX-1554 Single Ascending Dose (SAD) | Experimental | Drug: CFTX-1554Up to 7 dose levels with CFTX-1554 administered as oral liquid formulation under fasted conditions (at 1 single dose level only, drug intake under fed conditions, and as capsule under fasted conditions and under fed conditions, will be assessed) |
| Part A placebo | Placebo comparator | Drug: PlaceboSingle placebo administration in study Part A |
| Part B: CFTX-1554 Multiple Ascending Dose (MAD) | Experimental | Drug: CFTX-1554Up to 4 dose levels with CFTX-1554 in Part B. Doses and dosing frequency will be decided based on the results of study Part A. |
| Part B placebo | Placebo comparator | Drug: PlaceboMultiple placebo administration in study Part B |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Body mass index 18.0 to 30.0 kg/m2
- Females may be of childbearing potential but not pregnant or lactating, or of nonchildbearing potential; all females will be required to have a negative serum pregnancy test conducted at screening, (each) admission, and follow-up.
- Female subjects of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception from at least 4 weeks prior to first administration of study drug until 90 days after the follow up visit.
- Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit.
- All prescribed medication must have been stopped at least 30 days prior to first admission to the clinical research center.
Key exclusion criteria (14 listed)
- Previous participation in the current study
- History of relevant drug and/or food allergies
- Allergy or hypersensitivity to active ingredient or excipients of the study drug
- Using nicotine-containing products within 60 days prior to the first study drug administration
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 1 year before screening
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 |
|---|---|---|
| CFTX-1554CFTX-1554 is a new chemical entity that binds to the angiotensin II type 2 receptor (AT2R). | Drug | Part A: CFTX-1554 Single Ascending Dose (SAD), Part B: CFTX-1554 Multiple Ascending Dose (MAD) |
| PlaceboCFTX-1554 matching placebo | Drug | Part A placebo, Part B placebo |
Primary outcome
Number of Participants With Adverse Events
Time frame: Day -1 through Day 13 (Single Ascending Dose study part) or Day 26 (Multiple Ascending Dose study part)
Number of Participants With Adverse Events Following Oral Administration of CFTX-1554 in SAD (Part A) and MAD (Part B)
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 5 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Paolo Vicini, PhD study chair
Confo Therapeutics
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 CFTX-1554 in people with Healthy, run by Confo Therapeutics at 1 site in Netherlands.
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 10 inclusion and 14 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 5 Sep 2023. 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 Netherlands. 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?
Number of Participants With Adverse Events (time frame: Day -1 through Day 13 (Single Ascending Dose study part) or Day 26 (Multiple Ascending Dose study part)). 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 5 Sep 2023.