Healthy SubjectsPhase 1NCT03468413
A First-in-human Phase 1 Study of CP1050
A Phase 1 study of Healthy Subjects, run by Curadim Pharma Co., Ltd. at 1 site in United Kingdom.
Trial summary
This is a Phase I, first-in-human, double-blind, single-centre, randomised, placebo-controlled, single and multiple oral dose study in healthy subjects conducted in 4 parts (Part 1; Single-ascending dose, Part 2; Food-effect evaluation, Part 3; Gender-effect evaluation, Part 4; Multiple-ascending dose). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Feb 2018to Feb 2019
- 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
- Caucasian males or females between 18 and 55 years of age (inclusive).
- A body weight of ≥60 kg for males and ≥50 kg for females, with a body mass index (BMI) ranging from 18.0 to 30.0 kg/m2 (inclusive).
- Healthy and free from clinically significant illness or disease.
Who cannot join
- Presence or history of any clinically significant disease that could interfere with the objectives of the study or the safety of the subject in the opinion of the Investigator.
- Participation in more than 3 clinical studies involving administration of an IMP in the past one year, or any study within 12 weeks.
- Clinically significant abnormalities in ECG or laboratory tests.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Unit (CRU) Ltd.
Leeds, LS2 9LH
About this study
Official title: A Randomised, First-in-human, Double-blinded, Placebo-controlled Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of CP1050 in Healthy Subjects; Including the Effect of Food and Gender on the Pharmacokinetics and Pharmacodynamics of a Single Dose of CP1050 in Healthy Subjects
This is a Phase I, first-in-human, double-blind, single-centre, randomised, placebo-controlled, single and multiple oral dose study in healthy subjects conducted in 4 parts (Part 1; Single-ascending dose, Part 2; Food-effect evaluation, Part 3; Gender-effect evaluation, Part 4; Multiple-ascending dose).
- Conditions
- Healthy Subjects
- Being tested
- CP1050 or Placebo
- Keywords
- CP1050, Phase 1, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP1050 or PlaceboDrug
Randomised, double-blinded, placebo-controlled
| Study group | Role | What they receive |
|---|---|---|
| Single ascending dose, CP1050 or Placebo | Experimental | Not described Receives: Drug: CP1050 or Placebo |
| Multiple ascending dose, CP1050 or Placebo | Experimental | Not described Receives: Drug: CP1050 or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of any drug-related adverse events
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events
Measured: Up to 21 days
Number of subjects with abnormal vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate and oral body temperature)
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of vital signs
Measured: Up to 21 days
Number of subjects with abnormal clinical laboratory tests (including clinical chemistry, haematology and urinalysis)
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of clinical laboratory tests
Measured: Up to 21 days
Number of subjects with abnormal 12-lead safety ECG (including heart rate, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected for heart rate using Fridericia's method [QTcF])
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of 12-lead safety ECG
Measured: Up to 21 days
Number of subjects with abnormal 12-lead continuous (24-hour) ECG (including mean hourly heart rate and incidence of arrhythmia assessed as per the ECG Alert Criteria)
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of 12-lead continuous (24-hour) ECG
Measured: Up to 21 days
Number of subjects with abnormal Pulmonary function tests (including FEV1, FVC, FEF25-75 and DLCO [Part 4 only])
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of pulmonary function tests
Measured: Up to 21 days
Number of subjects with abnormal ophthalmological findings assessed by fundoscopy or OCT
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of ophthalmological assessments
Measured: Up to 21 days
Number of subjects with abnormal physical examinations
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of physical examinations
Measured: Up to 21 days
Secondary outcomes (8)
Maximum observed plasma concentration (Cmax)
Measured: Up to 21 days
Area under the plasma concentration-time curve (AUC)
Measured: Up to 21 days
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 21 days
Apparent plasma terminal elimination half-life (T1/2)
Measured: Up to 21 days
The lowest absolute value of lymphocytes at postdose (nadir)
Measured: Up to 21 days
The lowest percentage of baseline (nadir [%])
Measured: Up to 21 days
Time of nadir (Tnadir)
Measured: Up to 21 days
Area under the effectiveness curve (AUCE)
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start5 Feb 2018
- Primary completionAug 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curadim Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468413
- Sponsor's protocol ID
- CP1050-E101
- Status last verified
- Mar 2018
- First submitted
- 22 Feb 2018
- Last updated
- 16 Mar 2018
- 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 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, First-in-human, Double-blinded, Placebo-controlled Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of CP1050 in Healthy Subjects; Including the Effect of Food and Gender on the Pharmacokinetics and Pharmacodynamics of a Single Dose of CP1050 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03468413
- Acronym / sponsor ID
- CP1050-E101
- Conditions
- Healthy Subjects
- Keywords
- CP1050, Phase 1, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Curadim Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 16 Mar 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.
This is a Phase I, first-in-human, double-blind, single-centre, randomised, placebo-controlled, single and multiple oral dose study in healthy subjects conducted in 4 parts (Part 1; Single-ascending dose, Part 2; Food-effect evaluation, Part 3; Gender-effect evaluation, Part 4; Multiple-ascending dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single ascending dose, CP1050 or Placebo | Experimental | Drug: CP1050 or Placebo |
| Multiple ascending dose, CP1050 or Placebo | Experimental | Drug: CP1050 or Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Caucasian males or females between 18 and 55 years of age (inclusive).
- A body weight of ≥60 kg for males and ≥50 kg for females, with a body mass index (BMI) ranging from 18.0 to 30.0 kg/m2 (inclusive).
- Healthy and free from clinically significant illness or disease.
Key exclusion criteria (3 listed)
- Presence or history of any clinically significant disease that could interfere with the objectives of the study or the safety of the subject in the opinion of the Investigator.
- Participation in more than 3 clinical studies involving administration of an IMP in the past one year, or any study within 12 weeks.
- Clinically significant abnormalities in ECG or laboratory tests.
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 |
|---|---|---|
| CP1050 or PlaceboRandomised, double-blinded, placebo-controlled | Drug | Multiple ascending dose, CP1050 or Placebo, Single ascending dose, CP1050 or Placebo |
Primary outcome
Incidence and severity of any drug-related adverse events
Time frame: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events
Number of subjects with abnormal vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate and oral body temperature)
Time frame: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of vital signs
Number of subjects with abnormal clinical laboratory tests (including clinical chemistry, haematology and urinalysis)
Time frame: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of clinical laboratory tests
Number of subjects with abnormal 12-lead safety ECG (including heart rate, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected for heart rate using Fridericia's method [QTcF])
Time frame: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of 12-lead safety ECG
Number of subjects with abnormal 12-lead continuous (24-hour) ECG (including mean hourly heart rate and incidence of arrhythmia assessed as per the ECG Alert Criteria)
Time frame: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of 12-lead continuous (24-hour) ECG
Number of subjects with abnormal Pulmonary function tests (including FEV1, FVC, FEF25-75 and DLCO [Part 4 only])
Time frame: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of pulmonary function tests
Number of subjects with abnormal ophthalmological findings assessed by fundoscopy or OCT
Time frame: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of ophthalmological assessments
Number of subjects with abnormal physical examinations
Time frame: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of physical examinations
8 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Up to 21 days
Area under the plasma concentration-time curve (AUC)
Time frame: Up to 21 days
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 21 days
Apparent plasma terminal elimination half-life (T1/2)
Time frame: Up to 21 days
The lowest absolute value of lymphocytes at postdose (nadir)
Time frame: Up to 21 days
The lowest percentage of baseline (nadir [%])
Time frame: Up to 21 days
Time of nadir (Tnadir)
Time frame: Up to 21 days
Area under the effectiveness curve (AUCE)
Time frame: Up to 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- 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.
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 of Healthy Subjects, run by Curadim Pharma Co., Ltd. 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Mar 2018. 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. 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?
Results are not available in the source record.
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?
Incidence and severity of any drug-related adverse events (time frame: Up to 21 days). The study lists 8 primary outcomes in all. 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 16 Mar 2018.