HealthyPhase 1NCT05079425
A First-in-Human Study to Assess Single and Multiple Doses of NXC736 in Healthy Participants
A Phase 1 study testing NXC736 in people with Healthy, run by NEXTGEN Bioscience at 1 site in South Korea.
Trial summary
This is a randomized, double-blind, placebo- controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NXC736 after oral administration in healthy male volunteers. 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?
- NXC736
- 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
- 1 Sep 2021to 1 Nov 2022
- 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
- Healthy adult males aged between 19 and 55 at screening
- Those whose weight is between 55 and 90 kg and BMI is between 18.0 and 30.0
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
- Signed informed consent form
Who cannot join
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- Those who have gastrointestinal diseases or past history of gastrointestinal diseases that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
- A person who shows any of the following results in vital signs at the time of screening
- Systolic blood pressure below 90 mmHg or above 140 mmHg
- diastolic blood pressure less than 50 mmHg or greater than 90 mmHg
- Pulse rate less than 50 beats per minute or more than 90 beats per minute
Show all 18Show fewer
- A person who exhibits any of the following results from a 12-lead ECG test at the time of screening:
- PR > 210 msec
- QRS complex > 120 msec
- QTcB > 450 msec
- A person who exhibits any of the following results in a clinical laboratory examination at the time of screening ;
- glomerular filtration rate (eGFR, CKD-EPI) < 60 mL/min/1.73 m2
- WBC count < 3500/μL
- Absolute neutrophil count (ANC) < 1500/μL
- AST/ALT > 1.5 X ULN
- Those who have a history of tuberculosis infection or who have confirmed positive tuberculosis infection as a result of the Quantiferon TB-Gold test and Chest X-ray performed at the screening test
- Persons with acute infectious diseases including herpes virus infection, herpes simplex, and herpes zoster
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect After the Oral Administration of NXC736 in Healthy Male Subjects
This is a randomized, double-blind, placebo- controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NXC736 after oral administration in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- NXC736, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NXC736Drug
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Part A: Fasting | Experimental | Single ascending dose (SAD). Receives: Drug: NXC736; Drug: Placebo |
| Part A: Fed | Experimental | Single ascending dose (SAD). Receives: Drug: NXC736; Drug: Placebo |
| Part B: Fasting | Experimental | Multiple Ascending Dose (MAD) Receives: Drug: NXC736; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
Measured: Day 49
Number of Participants with Serious Adverse Events (SAEs)
Measured: Day 49
Number of Participants with Vital Sign Abnormalities
Measured: Day 49
Number of Participants with Electrocardiogram (ECG) Abnormalities
Measured: Day 49
Number of Participants with Clinical Laboratory Abnormalities
Measured: Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Sep 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- NEXTGEN Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seungwhan Lee, Principal investigator, Seoul National University College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079425
- Sponsor's protocol ID
- NXC736-001
- Status last verified
- Feb 2023
- First submitted
- 27 Sep 2021
- Last updated
- 8 Feb 2023
- Results posted
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect After the Oral Administration of NXC736 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05079425
- Acronym / sponsor ID
- NXC736-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- NEXTGEN BioscienceIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 15 Oct 2021 (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 randomized, double-blind, placebo- controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NXC736 after oral administration in healthy male volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Fasting | Experimental | Drug: NXC736, Drug: PlaceboSingle ascending dose (SAD). |
| Part A: Fed | Experimental | Drug: NXC736, Drug: PlaceboSingle ascending dose (SAD). |
| Part B: Fasting | Experimental | Drug: NXC736, Drug: PlaceboMultiple Ascending Dose (MAD) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult males aged between 19 and 55 at screening
- Those whose weight is between 55 and 90 kg and BMI is between 18.0 and 30.0
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
- Signed informed consent form
Key exclusion criteria (18 listed)
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- Those who have gastrointestinal diseases or past history of gastrointestinal diseases that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
- A person who shows any of the following results in vital signs at the time of screening
- A person who exhibits any of the following results from a 12-lead ECG test at the time of screening:
- A person who exhibits any of the following results in a clinical laboratory examination at the time of screening ;
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 |
|---|---|---|
| NXC736Oral administration | Drug | Part A: Fasting, Part A: Fed, Part B: Fasting |
| PlaceboOral administration | Drug | Part A: Fasting, Part A: Fed, Part B: Fasting |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Day 49
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Day 49
Number of Participants with Vital Sign Abnormalities
Time frame: Day 49
Number of Participants with Electrocardiogram (ECG) Abnormalities
Time frame: Day 49
Number of Participants with Clinical Laboratory Abnormalities
Time frame: Day 49
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 8 Feb 2023.
- 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.
Seungwhan Lee principal investigator
Seoul National University College of Medicine and 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 NXC736 in people with Healthy, run by NEXTGEN Bioscience 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 4 inclusion and 18 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 8 Feb 2023. 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. 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 Participants with Adverse Events (AEs) (time frame: Day 49). The study lists 5 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 8 Feb 2023.