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HealthyPhase 1NCT02924155

Clinical Study to Investigate the Systemic Exposure, Safety, and Local Tolerability of SJP002 Ophthalmic Solution in Healthy Male Volunteers

A Phase 1 study testing SJP002 in people with Healthy, run by Samjin Pharmaceutical Co., Ltd. at 1 site in South Korea.

Completed

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

Official record
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Trial summary

This is a phase1, single center, double-blind, placebo control, randomized study and consisted of single dosing(period 1) and multiple dosing(period 2). In this clinical trial, safety and local tolerability are evaluated for 7 days after single dosing of the investigational product. Read more about this study

Who is it for?
Ages 20 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
SJP002
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteSouth Korea
Study dates
5 Sep 2016to 17 Nov 2016
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 20 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject who voluntarily agrees to participate in this study and has given a written informed consent, after fully understanding the detailed explanation of this study
  • 20 years to 50 years (Healthy male Korean)

Who cannot join

  • Subject with a disease history of any clinically significant condition as below.
  • Liver, Kidney, nervous system, immune system, respiratory system, endocrine system, tumor, cardiovascular disease or mental illness (mood disorder or obsessive-compulsive disorder etc.) etc.
  • Subject with a history of clinically significant hypersensitivity or hypersensitivity reactions to drugs (aspirin, antibiotics, etc.)
  • Subject with a disease history of any ophthalmic condition as below
  • History of or suspected symptoms or signs of vision problems, including keratitis, uveitis, retinitis, dry eye syndrome, and strabismus.
  • Corrected eyesight measured at screening is 20/40 or less
Show all 19Show fewer
  • Those who have previously had ophthalmic surgery. (Exceptional case: in the case of having ophthalmic laser surgery before 6 months from the screening)
  • Those who have experienced side effects after wearing contact lenses, those who have worn contact lenses within the last month, or those who cannot ban wearing contact lens during the clinical trial
  • Abnormal findings in other ophthalmic examinations
  • Subject with a history of drug abuse or who is positive for drugs of abuse in urine tests at screening
  • Subject who received any drugs such as
  • Prescription drug or herbal medicine within 14 days prior to the first administration of the investigational products
  • Over the counter (OTC) or vitamin within 7 days prior to the first administration of the investigational products
  • Subject who received other investigational products within 90 days prior to the first administration of the investigational products
  • Subject who have donated whole blood within 60 days prior to the first administration of the investigational products, or donated component blood or have received blood transfusion within 30 days prior to the first administration of the investigational products
  • Subject who continuously drink alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from alcohol during the study period
  • Subject who smoked more than 10 cigarettes a day on average in the last 90 days, and who cannot quit smoking during hospitalization
  • Man of reproductive potential not willing to use contraceptive measures during the study period
  • Subject not eligible for study participation in the opinion of the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Single Day/Multiple Day Dosing, Phase I Clinical Trial to Investigate the Systemic Exposure, Safety and Local Tolerability of SJP002 Ophthalmic Solution in Healthy Korean Male Subjects

This is a phase1, single center, double-blind, placebo control, randomized study and consisted of single dosing(period 1) and multiple dosing(period 2).

In this clinical trial, safety and local tolerability are evaluated for 7 days after single dosing of the investigational product. If multiple dosing is judged to be acceptable as a result of single dosing evaluation (safety and local tolerability evaluation including ophthalmic examination), multiple dosing starts from Day 8(7 days after the single dosing) for 14 days. Safety and local tolerability, including ophthalmic symptom assessment, should be evaluated during the multiple dosing period.

Conditions
Healthy
Being tested
SJP002, Placebo

What participants receive

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

  • SJP002Drug

    1. Period 1 (single dose)
    • Day1: Placebo, Topical administered one drop to each eye (Once a day)
    • Day2: SJP002, Topical administered one drops to each eye (Once a day)
    • Day3: SJP002, Topical administered one drops to each eye (Administered 4 times a day [0h, 4h, 8h, 12h])
    1. Period 2 (multiple dose) - Day10~Day23: SJP002, Topical administered one drops to each eye (Administered 4 times a day [0h, 4h, 8h, 12h])

  • PlaceboDrug

    1. Period 1 (single dose)
    • Day1: Placebo, Topical administered one drop to each eye (Once a day)
    • Day2: Placebo, Topical administered one drops to each eye (Once a day)
    • Day3 Placebo, Topical administered one drops to each eye (Administered 4 times a day [0h, 4h, 8h, 12h])
    1. Period 2 (multiple dose) - Day10~Day23: Placebo, Topical administered one drops to each eye (Administered 4 times a day [0h, 4h, 8h, 12h])
Study groups in NCT02924155
Study groupRoleWhat they receive
SJP002Experimental9 subjects received single dose of SJP002 and then received multiple dose of SJP002
Receives: Drug: SJP002
PlaceboPlacebo comparator3 subjects received single dose of placebo and then received multiple dose of placebo
Receives: Drug: Placebo

What is being measured

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

  1. Incidence of Treatment Emergent Adverse Event(TEAE)

    Safety/Tolerability Assessment

    Measured: Day 1(administration) to approximately Day 37(Post study visit)

Secondary outcomes (10)

  1. Measure the Peak Plasma Concentration (Cmax) of SJP002

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Measured: Period 1: Day2(predose and 0.5~24 hours postdose)

  2. Measure the Area Under the plasma concentration versus time Curve from the first observed to last(AUClast) of SJP002

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product

    Measured: Period 1: Day2(predose and 0.5~24 hours postdose)

  3. Measure the Area Under the plasma concentration versus time Curve from the first sampled data extrapolated to infinity(AUCinf) of SJP002

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product

    Measured: Period 1: Day2(predose and 0.5~24 hours postdose)

  4. Measure the Time to peak drug concentration(Tmax) of SJP002

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Measured: Period 1: Day2(predose and 0.5~24 hours postdose)

  5. Measure the Half Life(t1/2) of SJP002

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Measured: Period 1: Day2(predose and 0.5~24 hours postdose)

  6. Measure the Trough Drug Concentration at steady state(Cmin,ss) of SJP002

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Measured: Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose)

  7. Measure the Area Under the plasma concentration-time Curve over a dosing interval at steady state(AUCtau,ss) of SJP002

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Measured: Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose)

  8. Measure the Time to peak drug concentration at steady state(Tmax,ss) of SJP002

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Measured: Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose)

  9. Measure the Half Life at steady state(T1/2,ss) of SJP002

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Measured: Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose)

  10. Measure the Peak Plasma Concentration Accumulation Ratio (RA,Cmax) of SJP002

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Measured: Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose)

Timeline

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

  1. First posted5 Oct 2016 (estimated)
  2. Study start5 Sep 2016
  3. Primary completion17 Nov 2016
  4. Study completion17 Nov 2016

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02924155
Sponsor's protocol ID
SJSJP002_01
Status last verified
Apr 2022
First submitted
28 Jul 2016
Last updated
14 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SJP002 in people with Healthy, run by Samjin Pharmaceutical Co., Ltd. at 1 site in South Korea.

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 2 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 14 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 South Korea. 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?

Incidence of Treatment Emergent Adverse Event(TEAE) (time frame: Day 1(administration) to approximately Day 37(Post study visit)). 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 NCT02924155.

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 14 Apr 2022.

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