HealthyPhase 1NCT03918967
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants
A Phase 1 study testing CT-G11 and CT-G20 in people with Healthy, run by Celltrion at 1 site in South Korea.
Trial summary
The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CT-G11 and CT-G20
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Apr 2019to 6 Jun 2020
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index (BMI) ≥18.0 and ≤30.0 kg/m2
Who cannot join
- Clinically significant allergic reactions
- Gastrointestinal, renal, hematological, metabolic, neurologic or pulmonary diseases classified as significant by the Investigator
- Hepatic dysfunction upper limit of normal laboratory range
- Cardiac history or presence
- History or any concomitant active malignancy
- A known infection with human immunodeficiency virus, hepatitis B virus (HBV) or hepatitis C virus (HCV)
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- Inherited bleeding diathesis or coagulopathy with the risk of bleeding
- Hemoptysis, thrombotic or hemorrhagic event
- Cerebral vascular accident, transient ischemic attack, or subarachnoid hemorrhage
- History and/or sign/symptoms of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
- Lactose intolerance (lactase deficiency) and glucose-galactose malabsorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-segment Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G11 and CT-G20 in Healthy Volunteers (Part 1 and Part 2) and Open Label, Balanced, Randomized, Two-period, Two-Sequence Crossover Study to Assess the Effect of Food on the Pharmacokinetics of CT-G20 in Healthy Volunteers (Part 3)
The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants. It will be conducted in three parts, as described below:
- Part I will be a randomized, double-blind, placebo-controlled, sequential, single ascending dose study.
- Part II will be a randomized, double-blind, placebo-controlled, sequential, multiple ascending dose study.
- Part III will be a randomized, open-label, balanced, two-period, two-sequence crossover, food effect study.
- Conditions
- Healthy
- Being tested
- CT-G11, CT-G20, CT-G11 Placebo, CT-G20 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-G11Drug
oral tablet of CT-G11 Experimental Drug
CT-G20Drug
oral tablet of CT-G20 Experimental Drug
CT-G11 PlaceboDrug
oral tablet of Placebo
CT-G20 PlaceboDrug
oral tablet of Placebo
| Study group | Role | What they receive |
|---|---|---|
| CT-G11 | Experimental | CT-G11 Experimental Drug Receives: Drug: CT-G11 |
| CT-G20 | Experimental | CT-G20 Experimental Drug Receives: Drug: CT-G20 |
| CT-G11 Placebo | Placebo comparator | Not described Receives: Drug: CT-G11 Placebo |
| CT-G20 Placebo | Placebo comparator | Not described Receives: Drug: CT-G20 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events including serious Adverse events (Part I, Part II)
Measured: 46 days
Food effect as assessed by : PK parameters including Area under the concentration-time curve (AUC) and Maximum observed concentration (Cmax) (Part III)
Measured: Up to 48 hours after administration
Secondary outcomes (12)
Safety parameters as assessed by: QT interval of ECG
Measured: 17 Days
Safety parameters as assessed by: QTcF of ECG
Measured: 17 Days
Safety parameters as assessed by: blood pressure of Vital signs
Measured: 17 Days
Safety parameters as assessed by: pulse rate of Vital signs
Measured: 17 Days
Safety parameters as assessed by: body temperature of Vital signs
Measured: 17 Days
Safety parameters as assessed by: hematology of Clinical laboratory tests
Measured: 17 Days
Safety parameters as assessed by: clinical chemistry
Measured: 17 Days
PK parameters as assessed by : Area under the concentration-time curve (AUC)
Measured: 13 Days
PK parameters as assessed by : Maximum observed concentration (Cmax)
Measured: 13 Days
PK parameters as assessed by : Time to Cmax (tmax)
Measured: 13 Days
PK parameters as assessed by : Terminal half-life time (t1/2)
Measured: 13 Days
PD parameters as assessed by : Left ventricular ejection fraction (LVEF)
Measured: 17 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start8 Apr 2019
- Primary completion6 Jun 2020
- Study completion6 Jun 2020
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918967
- Sponsor's protocol ID
- CT-G20 1.1
- Status last verified
- Jun 2020
- First submitted
- 9 Apr 2019
- Last updated
- 9 Jun 2020
- 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 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-segment Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G11 and CT-G20 in Healthy Volunteers (Part 1 and Part 2) and Open Label, Balanced, Randomized, Two-period, Two-Sequence Crossover Study to Assess the Effect of Food on the Pharmacokinetics of CT-G20 in Healthy Volunteers (Part 3)
- ClinicalTrials.gov ID
- NCT03918967
- Acronym / sponsor ID
- CT-G20 1.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 6 Jun 2020 (actual)
- Study completion
- 6 Jun 2020 (actual)
- First posted
- 18 Apr 2019 (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 establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants. It will be conducted in three parts, as described below:
- Part I will be a randomized, double-blind, placebo-controlled, sequential, single ascending dose study.
- Part II will be a randomized, double-blind, placebo-controlled, sequential, multiple ascending dose study.
- Part III will be a randomized, open-label, balanced, two-period, two-sequence crossover, food effect study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CT-G11 | Experimental | Drug: CT-G11CT-G11 Experimental Drug |
| CT-G20 | Experimental | Drug: CT-G20CT-G20 Experimental Drug |
| CT-G11 Placebo | Placebo comparator | Drug: CT-G11 Placebo |
| CT-G20 Placebo | Placebo comparator | Drug: CT-G20 Placebo |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- body mass index (BMI) ≥18.0 and ≤30.0 kg/m2
Key exclusion criteria (11 listed)
- Clinically significant allergic reactions
- Gastrointestinal, renal, hematological, metabolic, neurologic or pulmonary diseases classified as significant by the Investigator
- Hepatic dysfunction upper limit of normal laboratory range
- Cardiac history or presence
- History or any concomitant active malignancy
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 |
|---|---|---|
| CT-G11oral tablet of CT-G11 Experimental Drug | Drug | CT-G11 |
| CT-G20oral tablet of CT-G20 Experimental Drug | Drug | CT-G20 |
| CT-G11 Placebooral tablet of Placebo | Drug | CT-G11 Placebo |
| CT-G20 Placebooral tablet of Placebo | Drug | CT-G20 Placebo |
Primary outcome
Incidence of Adverse events including serious Adverse events (Part I, Part II)
Time frame: 46 days
Food effect as assessed by : PK parameters including Area under the concentration-time curve (AUC) and Maximum observed concentration (Cmax) (Part III)
Time frame: Up to 48 hours after administration
12 secondary outcomes
Safety parameters as assessed by: QT interval of ECG
Time frame: 17 Days
Safety parameters as assessed by: QTcF of ECG
Time frame: 17 Days
Safety parameters as assessed by: blood pressure of Vital signs
Time frame: 17 Days
Safety parameters as assessed by: pulse rate of Vital signs
Time frame: 17 Days
Safety parameters as assessed by: body temperature of Vital signs
Time frame: 17 Days
Safety parameters as assessed by: hematology of Clinical laboratory tests
Time frame: 17 Days
Safety parameters as assessed by: clinical chemistry
Time frame: 17 Days
PK parameters as assessed by : Area under the concentration-time curve (AUC)
Time frame: 13 Days
PK parameters as assessed by : Maximum observed concentration (Cmax)
Time frame: 13 Days
PK parameters as assessed by : Time to Cmax (tmax)
Time frame: 13 Days
PK parameters as assessed by : Terminal half-life time (t1/2)
Time frame: 13 Days
PD parameters as assessed by : Left ventricular ejection fraction (LVEF)
Time frame: 17 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 9 Jun 2020.
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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.
In-Jin Jang principal investigator
Seoul National University Hospital
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 CT-G11 and CT-G20 in people with Healthy, run by Celltrion 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 1 inclusion and 11 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 9 Jun 2020. 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 Adverse events including serious Adverse events (Part I, Part II) (time frame: 46 days). The study lists 2 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 9 Jun 2020.