Healthy VolunteersPhase 1NCT03058458
A First Time in Human Study of PIN201104 in Healthy Volunteers and Patients With Asthma
A Phase 1 study testing PIN201104 in people with Healthy Volunteers and Asthma, run by Peptinnovate at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of different single and repeat doses of PIN201104 in healthy volunteers and in patients with asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Asthma
- What is being tested?
- PIN201104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2017to Jan 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects of non-childbearing potential age 18 to 65 years of age, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
- Written informed consent must be obtained before any assessment is performed.
- Able to communicate well with the Investigator/designee.
Who cannot join
- Any known reaction to study drug or components
- concurrent or recent infection or clinically significant conditions that may place subject at risk or interference with absorption, distribution or excretion of drugs
- No QTcF interval ≥450 milliseconds, no QRS complex ≥120 milliseconds, at Screening
- Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or -2 antibodies at Screening.
- Excessive use of caffeine-containing beverages
- Urinary cotinine level indicative of smoking or history or regular use of tobacco- or nicotine containing products within 6 months before screening.
Show all 13Show fewer
- History of regular alcohol consumption within 6 months of screening 10.
- Positive screen for drugs-of-abuse or cotinine.
- Blood donation in excess of 500mL within 3 months.
- Participation in another study with an experimental drug within 3 months of first IMP administration.
- Exposure to more than 4 new chemical entities within 12 months before the first IMP administration.
- Ongoing rhinitis that requires treatment.
- Use of live vaccine 28 days before dosing with study drug until telephone follow-up and use of killed vaccine 14 days before dosing with study drug until telephone follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-time-in-human, Randomised, Double-blind, Placebo-controlled, Parallel-group Study in Healthy Volunteers and Patients With Asthma to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending and Repeat Doses of PIN201104
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of different single and repeat doses of PIN201104 in healthy volunteers and in patients with asthma.
- Conditions
- Healthy Volunteers, Asthma
- Being tested
- PIN201104, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIN201104Drug
IV or SC administration
PlaceboDrug
IV or SC administration
| Study group | Role | What they receive |
|---|---|---|
| SAD PIN201104 in Healthy Volunteers (HV) | Experimental | PIN201104 or placebo IV administration, single dose, 10 dose cohorts Receives: Drug: PIN201104; Drug: Placebo |
| Repeat dose PIN201104 in HV | Experimental | PIN201104 or placebo IV administration, 3 doses on single day, 1 cohort Receives: Drug: PIN201104; Drug: Placebo |
| Single dose PIN201104 in asthma patients | Experimental | PIN201104 or placebo IV administration, single dose, 2 cohorts Receives: Drug: PIN201104; Drug: Placebo |
| Single SC dose in HV | Experimental | PIN201104 or placebo SC administration, single dose, 1 cohort Receives: Drug: PIN201104; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with TEAEs and number of events will be summarised by treatment
Treatment Emergent Adverse Events after single and multiple dose administration will be collected at baseline and repeated until study completion
Measured: 21 days
Secondary outcomes (10)
Number of subjects with clinically significant abnormal haematology variables will be summarised by treatment.
Haemoglobin, haematocrit, MCV, MCH, MCHC, RBC, WBC and differentials will be collected at baseline and after single and multiple dose administration and repeated until Day 14.
Measured: 14 days
Number of subjects with clinically significant abnormal clinical chemistry variables will be summarised by treatment.
Creatinine, glucose, triglycerides, urea, uric acid, bilirubin, cholesterol, sodium, potassium, alkaline phosphatase, AST, ALT and GGT will be collected at baseline and after single and multiple dose administration and repeated until Day 14.
Measured: 14 days
Number of subjects with clinically significant abnormal electrocardiogram variables will be summarised by treatment.
RR-interval, PR (PQ)-interval, QRS-duration, QT-interval, QTcB, QTcF and heart rate will be collected at baseline and after single and multiple dose administration and repeated until Day 14.
Measured: 14 days
Number of subjects with clinically significant abnormal vital sign variables will be summarised by treatment.
Blood pressure, pulse rate, oral body temperature and respiration rate will be collected at baseline and after single and multiple dose administration and repeated until Day 14.
Measured: 14 days
Pharmacokinetics of PIN201104: The maximum observed plasma concentration (Cmax)
Cmax will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Measured: 24 hours
PK of PIN201104: The time to reach Cmax (Tmax)
Tmax will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Measured: 24 hours
PK of PIN201104: Apparent terminal elimination half life in plasma (t1/2)
t1/2 will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Measured: 24 hours
PK of PIN201104: Area under the curve from time zero to the last quantifiable concentration of PIN201104 (AUC0-t)
AUC0-t will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Measured: 24 hours
PK of PIN201104: Apparent plasma clearance of PIN201104 (CL/F)
CL/F will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Measured: 24 hours
PK of PIN201104: Apparent volume of distribution (Vz/F)
Vz/F will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startJan 2017
- Primary completionJan 2018
- Study completionJan 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peptinnovate
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muna Albayaty, MBChB, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058458
- Sponsor's protocol ID
- C1104-001
- Status last verified
- Jan 2018
- First submitted
- 24 Jan 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-time-in-human, Randomised, Double-blind, Placebo-controlled, Parallel-group Study in Healthy Volunteers and Patients With Asthma to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending and Repeat Doses of PIN201104
- ClinicalTrials.gov ID
- NCT03058458
- Acronym / sponsor ID
- C1104-001
- Conditions
- Healthy Volunteers, Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- PeptinnovateIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 23 Feb 2017 (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 purpose of this study is to assess the safety, tolerability and pharmacokinetics of different single and repeat doses of PIN201104 in healthy volunteers and in patients with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAD PIN201104 in Healthy Volunteers (HV) | Experimental | Drug: PIN201104, Drug: PlaceboPIN201104 or placebo IV administration, single dose, 10 dose cohorts |
| Repeat dose PIN201104 in HV | Experimental | Drug: PIN201104, Drug: PlaceboPIN201104 or placebo IV administration, 3 doses on single day, 1 cohort |
| Single dose PIN201104 in asthma patients | Experimental | Drug: PIN201104, Drug: PlaceboPIN201104 or placebo IV administration, single dose, 2 cohorts |
| Single SC dose in HV | Experimental | Drug: PIN201104, Drug: PlaceboPIN201104 or placebo SC administration, single dose, 1 cohort |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male and female subjects of non-childbearing potential age 18 to 65 years of age, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
- Written informed consent must be obtained before any assessment is performed.
- Able to communicate well with the Investigator/designee.
Key exclusion criteria (13 listed)
- Any known reaction to study drug or components
- concurrent or recent infection or clinically significant conditions that may place subject at risk or interference with absorption, distribution or excretion of drugs
- No QTcF interval ≥450 milliseconds, no QRS complex ≥120 milliseconds, at Screening
- Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or -2 antibodies at Screening.
- Excessive use of caffeine-containing beverages
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 |
|---|---|---|
| PIN201104IV or SC administration | Drug | Repeat dose PIN201104 in HV, SAD PIN201104 in Healthy Volunteers (HV), Single SC dose in HV, Single dose PIN201104 in asthma patients |
| PlaceboIV or SC administration | Drug | Repeat dose PIN201104 in HV, SAD PIN201104 in Healthy Volunteers (HV), Single SC dose in HV, Single dose PIN201104 in asthma patients |
Primary outcome
Number of subjects with TEAEs and number of events will be summarised by treatment
Time frame: 21 days
Treatment Emergent Adverse Events after single and multiple dose administration will be collected at baseline and repeated until study completion
10 secondary outcomes
Number of subjects with clinically significant abnormal haematology variables will be summarised by treatment.
Time frame: 14 days
Number of subjects with clinically significant abnormal clinical chemistry variables will be summarised by treatment.
Time frame: 14 days
Number of subjects with clinically significant abnormal electrocardiogram variables will be summarised by treatment.
Time frame: 14 days
Number of subjects with clinically significant abnormal vital sign variables will be summarised by treatment.
Time frame: 14 days
Pharmacokinetics of PIN201104: The maximum observed plasma concentration (Cmax)
Time frame: 24 hours
PK of PIN201104: The time to reach Cmax (Tmax)
Time frame: 24 hours
PK of PIN201104: Apparent terminal elimination half life in plasma (t1/2)
Time frame: 24 hours
PK of PIN201104: Area under the curve from time zero to the last quantifiable concentration of PIN201104 (AUC0-t)
Time frame: 24 hours
PK of PIN201104: Apparent plasma clearance of PIN201104 (CL/F)
Time frame: 24 hours
PK of PIN201104: Apparent volume of distribution (Vz/F)
Time frame: 24 hours
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 25 Jan 2018.
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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.
Muna Albayaty, MBChB principal investigator
Parexel
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 PIN201104 in people with Healthy Volunteers and Asthma, run by Peptinnovate 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 13 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 25 Jan 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?
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 subjects with TEAEs and number of events will be summarised by treatment (time frame: 21 days). 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 25 Jan 2018.