Healthy VolunteersPhase 1NCT03686930

Multiple-Dose, Dose-Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045

A Phase 1 study testing Cohort 1 - FP-045 oral solution, Cohort 2 - FP-045 oral solution and Cohort 3 - FP-045 oral solution in people with Healthy Volunteers, run by Foresee Pharmaceuticals Co., Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Cohort 1 - FP-045 oral solution, Cohort 2 - FP-045 oral solution and Cohort 3 - FP-045 oral solution
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteAustralia
Study dates: 22 Feb 2018to 10 Aug 2018
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

Male or female NHV, age 18 to 55 years, inclusive (at the time of informed consent).
Females must be either postmenopausal for ≥1 year (or with FSH ≥ 40 mIU/mL if postmenopausal for < 1 year) or surgically sterile (having undergone bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 6 months.
Males with female partners of childbearing potential must agree to use barrier contraceptive (i.e., condom) and their female partners must use a highly effective method of contraception from Screening through 90 days after the last dose of study drug. Males must also refrain from sperm donations during this time period.
Males who are abstinent will not be required to use a contraceptive method unless they become sexually active.
The subject is, in the opinion of the Investigator, generally healthy based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
Baseline laboratory test values within reference ranges based on the blood and urine samples taken at Screening and on Day -1 (before administration of the initial study drug). Out of normal ranges values may be accepted by the Investigator, if not clinically significant.

Show all 9Show fewer

Nonsmoker and/or ex-smoker who has discontinued smoking and/or use of nicotine containing products for at least 6 months prior to the first dose of study drug
Body mass index between 18 and 30 kg/m2, inclusive
Written informed consent obtained Ability to communicate well with the Investigator, in the local language, and to understand and comply with the requirements of the study.

Who cannot join

History or presence of any clinically significant neurological, metabolic, gastrointestinal, endocrinological (in particular diabetes or pre-diabetes), cardiovascular, hematological, hepatic, immunological, renal, respiratory, chronic infections, psychiatric, or genitourinary abnormalities or diseases. Note: NHVs with a history of uncomplicated kidney stones or asthma may be enrolled in the study at the discretion of the Investigator.
History of malignant neoplastic disease, with the following exceptions:
Adequately treated non-melanomatous skin carcinoma
Female with a history of benign cervical carcinoma neoplasia if compliant with surveillance and treatment as recommended by her physician
Mentally or legally incapacitated, has significant emotional problems at Screening or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years. Note: NHVs who have had situational depression may be enrolled in the study at the discretion of the Investigator.
The subject has a history of severe drug allergy or hypersensitivity or food allergy, including anaphylaxis.

Show all 23Show fewer

The subject has had surgery or trauma with significant blood loss within the last 3 months prior to the first dose of study drug.
The subject has donated blood more than 1 unit (500 mL) with 4 weeks prior to the first dose of study drug.
Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening
Blood pressure >140/90 mm Hg or heart rate >100 beats per minute at Screening or at Day -1. Vitals may be repeated up to 2 times for the purpose of eligibility.
Clinically significant laboratory abnormalities including:
Impaired renal function (serum creatinine levels >ULN) at Screening; estimated creatinine clearance (CrCl) of <80 mL/min
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values >1.2 × upper normal limits
Clinically significant abnormality on ECG performed at Screening or prior to administration of the initial dose of study drug. (Screening ECG conduction intervals must be 10. Clinically significant abnormality on ECG performed at Screening or prior to administration of the initial dose of study drug. (Screening ECG conduction intervals must be within gender specific normal ranges [QT interval corrected for heart rate [QTc] males ≤450 msec and females ≤470 msec].)
Positive test for hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus antibody at Screening
Positive screen for drugs with a high potential for abuse (amphetamine, cannabinoid, cocaine, morphine, and phencyclidine) at Screening and Study Day -1.
Consumed food or drink containing grapefruit juice within 72 hours before start of dosing or expected to do so through EOS/ET
Consumed alcohol within 72 hours before start of dosing through EOS/ET.
Received any previous FP-045 or has taken any investigational product within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
Female who is breastfeeding or has a positive pregnancy test
Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for the scheduled EOS Visit
The subject has taken prescription medications within 2 weeks (or within 5 half-lives, whichever is longer) or nonprescription medication, herbal remedies, vitamins or minerals within 1 week prior to the administration of the initial dose of study drug and continuing throughout the study until the final study visit. Note: There may be certain medications that are permitted at the discretion of the Investigator and Sponsor (including paracetamol/ acetaminophen, which may be used for minor ailments during the course of the study without prior consultation with the Sponsor's Medical Monitor).
The subject exercises extensively (e.g. marathon, triathlon or other similar high energetic sports). In general, subjects should refrain from sporting for at least 4 days before participation in the study until the EOS/ET visit.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Nucleus Networks
Melbourne

Other trials in Australia

About this study

Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045 Administered Orally to Normal, Healthy Volunteers

Phase I, single-center, randomized, double-blind, placebo-controlled, multiple ascending dose (MAD), study to evaluate the safety/tolerability and pharmacokinetics (PK) of FP-045 administered to normal health volunteers (NHVs). 3 cohorts of NHVs will be enrolled. Subjects in each cohort will be randomized to orally receive either FP-045 (6 subjects) or placebo (2 subjects). Subjects will receive 7 daily doses of study drug.

Subjects will be screened for study eligibility within 21 days before Day 1 and will have been admitted to the CRU on Day -1 to confirm eligibility and to undergo baseline assessments. Subjects will remain in the CRU for observation until completion of all assessments on Day 10. Subjects will return to the CRU on Day 11 for an additional PK sample, and again for an end of study (EOS) Visit on Day 14 (±2 days) for safety evaluations and collection of PK samples.

Conditions: Healthy Volunteers
Being tested: Cohort 1 - FP-045 oral solution, Cohort 2 - FP-045 oral solution, Cohort 3 - FP-045 oral solution, Placebo (for FP-045 oral solution)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cohort 1 - FP-045 oral solutionDrug
FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.
Cohort 2 - FP-045 oral solutionDrug
FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.
Cohort 3 - FP-045 oral solutionDrug
FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.
Placebo (for FP-045 oral solution)Drug
Participants (cohorts 1-3) will receive FP-045 oral solution matching placebo.

Study groups in NCT03686930
Study group	Role	What they receive
Cohort 1 - FP-045 oral solution	Active comparator	FP-045 powder for oral solution, will be reconstituted once daily (QD) dose, administered for 7 consecutive days. Receives: Drug: Cohort 1 - FP-045 oral solution
Cohort 1 - Placebo for FP-045 oral solution	Placebo comparator	Placebo oral solution that is identical to the test product, but without FP-045. Receives: Drug: Placebo (for FP-045 oral solution)
Cohort 2 - FP-045 oral solution	Active comparator	FP-045 powder for oral solution (escalated dose), will be reconstituted once daily (QD) dose, administered for 7 consecutive days. Receives: Drug: Cohort 2 - FP-045 oral solution
Cohort 2 - Placebo for FP-045 oral solution	Placebo comparator	Placebo oral solution that is identical to the test product, but without FP-045. Receives: Drug: Placebo (for FP-045 oral solution)
Cohort 3 - FP-045 oral solution	Active comparator	FP-045 powder for oral solution (escalated dose), will be reconstituted once daily (QD) dose, administered for 7 consecutive days. Receives: Drug: Cohort 3 - FP-045 oral solution
Cohort 3 - Placebo for FP-045 oral solution	Placebo comparator	Placebo oral solution that is identical to the test product, but without FP-045. Receives: Drug: Placebo (for FP-045 oral solution)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in baseline measures for vital sign parameters [safety/tolerability]
Outcome Measures units of measure include weight in kilograms.
Measured: 14 days ± 2 days
Change in baseline measures for ECG parameters [safety/tolerability]
T wave
Measured: 14 days ± 2 days
Change in baseline measures for clinical laboratory test [safety/tolerability]
Number of Participants with Abnormal Laboratory Values. Blood will be drawn to measure the chemistry of the blood prior to and after dosing.
Measured: 14 days ± 2 days
Number of participants with treatment-emergent ECG abnormalities [safety/tolerability].
Measured: 14 days ± 2 days
Number of participants with treatment-emergent AEs [safety/tolerability].
Measured: 14 days ± 2 days
Number of participants with treatment-emergent AEs leading to premature discontinuation of study drug [safety/tolerability].
Measured: 14 days ± 2 days
Number of participants with treatment-emergent SAEs [safety/tolerability].
Measured: 14 days ± 2 days
Change in baseline measures for vital sign parameters [safety/tolerability]
Outcome Measures units of measure include height in meters.
Measured: 14 days ± 2 days
Change in baseline measures for vital sign parameters [safety/tolerability]
Outcome Measures units of measure include blood pressure both systolic and diastolic will be measured.
Measured: 14 days ± 2 days

Secondary outcomes (10)

Pharmacokinetic (PK) profile (Cmax) following multiple, escalating oral doses of FP-045.
Cmax (maximum plasma concentration) -first and last doses (Day 1 and Day 7) of FP-045 will be measured.
Measured: 14 days ± 2 days
Pharmacokinetic (PK) profile (Tmax) following multiple, escalating oral doses of FP-045.
Tmax (time to maximum plasma concentration) -first and last doses (Day 1 and Day 7) of FP-045 will be measured.
Measured: 14 days ± 2 days
Pharmacokinetic (PK) profile (AUC0-24) following multiple, escalating oral doses of FP-045.
AUC0-24 (area under the curve from time 0 to 24 hours postdose) - first dose (Day 1) of FP-045 will be measured.
Measured: 14 days ± 2 days
Pharmacokinetic (PK) profile (Cavg) following multiple, escalating oral doses of FP-045.
Cavg (average plasma concentration over the dosing interval) = AUC0-24/τ, where τ is the dosing interval - last dose (Day 7) of FP-045 will be measured.
Measured: 14 days ± 2 days
Pharmacokinetic (PK) profile (accumulation ratio of AUC0-24) following multiple, escalating oral doses of FP-045.
Accumulation ratio of AUC0-24 (Day 7)/AUC0-24 (Day 1) of FP-045 will be measured.
Measured: 14 days ± 2 days
Pharmacokinetic (PK) profile (AUC[0-24]) following multiple, escalating oral doses of FP-045.
AUC[0-24](area under the curve over the dosing interval) - Day 7 of FP-045 will be measured.
Measured: 14 days ± 2 days
Other pharmacokinetic (PK) profiles measured include t1/2 (terminal half-life) following multiple, escalating oral doses of FP-045.
Measured: 14 days ± 2 days
Other pharmacokinetic (PK) profiles measured include CL/F (apparent clearance) following multiple, escalating oral doses of FP-045.
Measured: 14 days ± 2 days
Other pharmacokinetic (PK) profiles measured include Vz/F (apparent volume of distribution) following multiple, escalating oral doses of FP-045.
Measured: 14 days ± 2 days
Other pharmacokinetic (PK) profiles measured include elimination rate constant following multiple, escalating oral doses of FP-045.
Measured: 14 days ± 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 201810 Aug 2018

First posted27 Sep 2018
Study start22 Feb 2018
Primary completion27 May 2018
Study completion10 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Multiple Dose, Dose Escalation study
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03686930
Sponsor's protocol ID: FP045C-17-001
Status last verified: Apr 2022
First submitted: 10 Apr 2018
Last updated: 29 Apr 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingPhase 1
First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers
Healthy

All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045 Administered Orally to Normal, Healthy Volunteers
ClinicalTrials.gov ID: NCT03686930
Acronym / sponsor ID: FP045C-17-001
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Foresee Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 22 Feb 2018 (actual)
Primary completion: 27 May 2018 (actual)
Study completion: 10 Aug 2018 (actual)
First posted: 27 Sep 2018 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6
Model description: Multiple Dose, Dose Escalation study

Arm	Type	Receives
Cohort 1 - FP-045 oral solution	Active comparator	Drug: Cohort 1 - FP-045 oral solutionFP-045 powder for oral solution, will be reconstituted once daily (QD) dose, administered for 7 consecutive days.
Cohort 1 - Placebo for FP-045 oral solution	Placebo comparator	Drug: Placebo (for FP-045 oral solution)Placebo oral solution that is identical to the test product, but without FP-045.
Cohort 2 - FP-045 oral solution	Active comparator	Drug: Cohort 2 - FP-045 oral solutionFP-045 powder for oral solution (escalated dose), will be reconstituted once daily (QD) dose, administered for 7 consecutive days.
Cohort 2 - Placebo for FP-045 oral solution	Placebo comparator	Drug: Placebo (for FP-045 oral solution)Placebo oral solution that is identical to the test product, but without FP-045.
Cohort 3 - FP-045 oral solution	Active comparator	Drug: Cohort 3 - FP-045 oral solutionFP-045 powder for oral solution (escalated dose), will be reconstituted once daily (QD) dose, administered for 7 consecutive days.
Cohort 3 - Placebo for FP-045 oral solution	Placebo comparator	Drug: Placebo (for FP-045 oral solution)Placebo oral solution that is identical to the test product, but without FP-045.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Male or female NHV, age 18 to 55 years, inclusive (at the time of informed consent).
Females must be either postmenopausal for ≥1 year (or with FSH ≥ 40 mIU/mL if postmenopausal for < 1 year) or surgically sterile (having undergone bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 6 months.
Males with female partners of childbearing potential must agree to use barrier contraceptive (i.e., condom) and their female partners must use a highly effective method of contraception from Screening through 90 days after the last dose of study drug. Males must also refrain from sperm donations during this time period.
Males who are abstinent will not be required to use a contraceptive method unless they become sexually active.
The subject is, in the opinion of the Investigator, generally healthy based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests.

Key exclusion criteria (23 listed)

History or presence of any clinically significant neurological, metabolic, gastrointestinal, endocrinological (in particular diabetes or pre-diabetes), cardiovascular, hematological, hepatic, immunological, renal, respiratory, chronic infections, psychiatric, or genitourinary abnormalities or diseases. Note: NHVs with a history of uncomplicated kidney stones or asthma may be enrolled in the study at the discretion of the Investigator.
History of malignant neoplastic disease, with the following exceptions:
Mentally or legally incapacitated, has significant emotional problems at Screening or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years. Note: NHVs who have had situational depression may be enrolled in the study at the discretion of the Investigator.
The subject has a history of severe drug allergy or hypersensitivity or food allergy, including anaphylaxis.
The subject has had surgery or trauma with significant blood loss within the last 3 months prior to the first dose of study drug.

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
Cohort 1 - FP-045 oral solutionFP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.	Drug	Cohort 1 - FP-045 oral solution
Cohort 2 - FP-045 oral solutionFP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.	Drug	Cohort 2 - FP-045 oral solution
Cohort 3 - FP-045 oral solutionFP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.	Drug	Cohort 3 - FP-045 oral solution
Placebo (for FP-045 oral solution)Participants (cohorts 1-3) will receive FP-045 oral solution matching placebo.	Drug	Cohort 1 - Placebo for FP-045 oral solution, Cohort 2 - Placebo for FP-045 oral solution, Cohort 3 - Placebo for FP-045 oral solution

Primary outcome

Change in baseline measures for vital sign parameters [safety/tolerability]
Time frame: 14 days ± 2 days
Outcome Measures units of measure include weight in kilograms.
Change in baseline measures for ECG parameters [safety/tolerability]
Time frame: 14 days ± 2 days
T wave
Change in baseline measures for clinical laboratory test [safety/tolerability]
Time frame: 14 days ± 2 days
Number of Participants with Abnormal Laboratory Values. Blood will be drawn to measure the chemistry of the blood prior to and after dosing.
Number of participants with treatment-emergent ECG abnormalities [safety/tolerability].
Time frame: 14 days ± 2 days
Number of participants with treatment-emergent AEs [safety/tolerability].
Time frame: 14 days ± 2 days
Number of participants with treatment-emergent AEs leading to premature discontinuation of study drug [safety/tolerability].
Time frame: 14 days ± 2 days
Number of participants with treatment-emergent SAEs [safety/tolerability].
Time frame: 14 days ± 2 days
Change in baseline measures for vital sign parameters [safety/tolerability]
Time frame: 14 days ± 2 days
Outcome Measures units of measure include height in meters.
Change in baseline measures for vital sign parameters [safety/tolerability]
Time frame: 14 days ± 2 days
Outcome Measures units of measure include blood pressure both systolic and diastolic will be measured.

10 secondary outcomes

Pharmacokinetic (PK) profile (Cmax) following multiple, escalating oral doses of FP-045.
Time frame: 14 days ± 2 days
Pharmacokinetic (PK) profile (Tmax) following multiple, escalating oral doses of FP-045.
Time frame: 14 days ± 2 days
Pharmacokinetic (PK) profile (AUC0-24) following multiple, escalating oral doses of FP-045.
Time frame: 14 days ± 2 days
Pharmacokinetic (PK) profile (Cavg) following multiple, escalating oral doses of FP-045.
Time frame: 14 days ± 2 days
Pharmacokinetic (PK) profile (accumulation ratio of AUC0-24) following multiple, escalating oral doses of FP-045.
Time frame: 14 days ± 2 days
Pharmacokinetic (PK) profile (AUC[0-24]) following multiple, escalating oral doses of FP-045.
Time frame: 14 days ± 2 days
Other pharmacokinetic (PK) profiles measured include t1/2 (terminal half-life) following multiple, escalating oral doses of FP-045.
Time frame: 14 days ± 2 days
Other pharmacokinetic (PK) profiles measured include CL/F (apparent clearance) following multiple, escalating oral doses of FP-045.
Time frame: 14 days ± 2 days
Other pharmacokinetic (PK) profiles measured include Vz/F (apparent volume of distribution) following multiple, escalating oral doses of FP-045.
Time frame: 14 days ± 2 days
Other pharmacokinetic (PK) profiles measured include elimination rate constant following multiple, escalating oral doses of FP-045.
Time frame: 14 days ± 2 days

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 29 Apr 2022.
Individual participant dataSharing planned: Undecided

Related trials for Healthy Volunteers

Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingPhase 1
First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers
Healthy

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.

David Lau, Ph.D. study director

Foresee Pharma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 23 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 29 Apr 2022. 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 Australia. 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?

Change in baseline measures for vital sign parameters [safety/tolerability] (time frame: 14 days ± 2 days). The study lists 9 primary outcomes in all. 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 NCT03686930.

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 29 Apr 2022.