Healthy VolunteerPhase 1NCT05991362
A Phase I Study of GFH312 in Healthy Chinese Subjects
A Phase 1 study testing GFH312 100 mg, GFH312 200 mg and GFH312 120mg in people with Healthy Volunteer, run by Zhejiang Genfleet Therapeutics Co., Ltd. at 1 site in China.
Trial summary
The aim of this study was to evaluate the pharmacokinetic profile and observe the safety of GFH312 after single and multiple administrations in healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- GFH312 100 mg, GFH312 200 mg and GFH312 120mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2022to 30 May 2023
- 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
- Voluntarily participate in the study and sign the informed consent;
- Male or female healthy subjects aged 18-55 years (inclusive) (single sex ratio not less than 25% of the sample size of each cohort);
- Body mass index (BMI) between 18-28 kg/m2 (inclusive), and weight ≥ 50kg; BMI = Weight (kg) /[Height (m)]2.
- During the screening period and day 1, patients with normal or abnormal results but no clinical significance based on detailed medical history, comprehensive physical examination, laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), 12-lead electrocardiogram and vital signs.
- Able to communicate well with researchers, understand and comply with research requirements.
Who cannot join
- Any procedure or disease that may significantly alter drug absorption, distribution, metabolism, or excretion, or participation in this study may compromise the safety of the subject.
- Tuberculin test positive
- Abnormal electrocardiogram with clinical significance
- Use any prescription drugs, Chinese herbs and/or OTC or health products within 2 weeks before starting the administration.
- Women who are pregnant or breastfeeding, or subjects with positive pregnancy test results at the time of screening or at baseline, or who plan to become pregnant during the study period or within 30 days after the end of the study.
- Subjects who have any factors deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose and Multiple-dose Study Evaluating the Pharmacokinetics and Safety of GFH312 in Healthy Chinese Subjects
The aim of this study was to evaluate the pharmacokinetic profile and observe the safety of GFH312 after single and multiple administrations in healthy Chinese subjects.
Read the detailed description
This study was planned to enroll about 26 healthy subjects, subjects were planned to receive single administration of 100 mg GFH312, single administration of 200 mg GFH312, or multiple administrations of 120 mg GFH312, as well as their matching placebo. Subjects were randomized in 3:1 ratio in the single dose cohorts and in 4:1 ratio in the multiple dose cohort.
- Conditions
- Healthy Volunteer
- Being tested
- GFH312 100 mg, GFH312 200 mg, GFH312 120mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFH312 100 mgDrug
Also called GFH312
Participants receive single dose of GFH312 100 mg orally
GFH312 200 mgDrug
Also called GFH312
Participants receive single dose of GFH312 200 mg orally
GFH312 120mgDrug
Also called GFH312
Participants receive daily dose of GFH312 120mg orally for fourteen consecutive days
PlaceboOther
Participants receive placebo matching with GFH312
| Study group | Role | What they receive |
|---|---|---|
| SAD:100mg | Experimental | Participants received single PO dose of GFH312 100 mg. Receives: Drug: GFH312 100 mg |
| SAD:200mg | Experimental | Participants received single PO dose of GFH312 200 mg. Receives: Drug: GFH312 200 mg |
| MAD:120mg | Experimental | Participants received multiple PO doses of GFH312 120 mg for 14 days. Receives: Drug: GFH312 120mg |
| Placebo | Placebo comparator | Participants receiving placebo matching with the GFH312 dose groups Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of GFH312
The maximum observed plasma concentration (Cmax) was estimated based on the plasma concentrations of GFH312.
Measured: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
Time to peak drug concentration (Tmax) of GFH312
The time it takes for a drug to reach the maximum concentration (Cmax) after administration of GFH312
Measured: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
Terminal Elimination Half Life (t1/2) of GFH312
The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of GFH312
Measured: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of GFH312
The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) was estimated based on the plasma concentrations of GFH312
Measured: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of GFH312
The area under the plasma concentration-time curve from time zero to infinity (AUC 0-inf) was estimated based on the plasma concentrations of GFH312
Measured: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
The apparent systemic (or total body) clearance from plasma (or serum or blood (CL/F) following extravascular administration of GFH312
The systemic clearance (CL) was estimated based on the plasma concentrations of GFH312
Measured: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
The apparent volume of distribution during the terminal elimination phase (Vd/F) following extravascular administration of GFH312
The volume of distribution was estimated based on the plasma concentrations of GFH312
Measured: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
The observed maximum plasma (or serum or blood) concentration following drug administration at steady state (Cmax,ss)
Observed maximum concentration in the dosing interval at steady state
Measured: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
The lowest plasma (or serum or blood) concentration observed during a dosing interval at steady state (Cmin,ss)
Observed minimum concentration in the dosing interval at steady state.
Measured: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
Time to reach maximum concentration in the dosing interval at steady state (Tmax,ss)
If the same Cmax concentration occurs at different time points, Tmax is assigned to the first occurrence of Cmax.
Measured: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
The area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau (AUCtau,ss)
Dose-normalized AUC0- τ, calculated as AUC0-τ divided by actual dose administered.
Measured: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
Secondary outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly or birth defect in the offspring of a participant who received the study drug.
Measured: up to 30 days after the last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start29 Nov 2022
- Primary completion13 Feb 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Genfleet Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- LU Yongning, PHD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991362
- Sponsor's protocol ID
- GFH312X1102
- Status last verified
- Aug 2023
- First submitted
- 6 Jul 2023
- Last updated
- 23 Aug 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 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single-dose and Multiple-dose Study Evaluating the Pharmacokinetics and Safety of GFH312 in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT05991362
- Acronym / sponsor ID
- GFH312X1102
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Zhejiang Genfleet Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 14 Aug 2023 (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 aim of this study was to evaluate the pharmacokinetic profile and observe the safety of GFH312 after single and multiple administrations in healthy Chinese subjects.
Detailed description
This study was planned to enroll about 26 healthy subjects, subjects were planned to receive single administration of 100 mg GFH312, single administration of 200 mg GFH312, or multiple administrations of 120 mg GFH312, as well as their matching placebo. Subjects were randomized in 3:1 ratio in the single dose cohorts and in 4:1 ratio in the multiple dose cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAD:100mg | Experimental | Drug: GFH312 100 mgParticipants received single PO dose of GFH312 100 mg. |
| SAD:200mg | Experimental | Drug: GFH312 200 mgParticipants received single PO dose of GFH312 200 mg. |
| MAD:120mg | Experimental | Drug: GFH312 120mgParticipants received multiple PO doses of GFH312 120 mg for 14 days. |
| Placebo | Placebo comparator | Other: PlaceboParticipants receiving placebo matching with the GFH312 dose groups |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Voluntarily participate in the study and sign the informed consent;
- Male or female healthy subjects aged 18-55 years (inclusive) (single sex ratio not less than 25% of the sample size of each cohort);
- Body mass index (BMI) between 18-28 kg/m2 (inclusive), and weight ≥ 50kg; BMI = Weight (kg) /[Height (m)]2.
- During the screening period and day 1, patients with normal or abnormal results but no clinical significance based on detailed medical history, comprehensive physical examination, laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), 12-lead electrocardiogram and vital signs.
- Able to communicate well with researchers, understand and comply with research requirements.
Key exclusion criteria (6 listed)
- Any procedure or disease that may significantly alter drug absorption, distribution, metabolism, or excretion, or participation in this study may compromise the safety of the subject.
- Tuberculin test positive
- Abnormal electrocardiogram with clinical significance
- Use any prescription drugs, Chinese herbs and/or OTC or health products within 2 weeks before starting the administration.
- Women who are pregnant or breastfeeding, or subjects with positive pregnancy test results at the time of screening or at baseline, or who plan to become pregnant during the study period or within 30 days after the end of the study.
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 |
|---|---|---|
| GFH312 100 mgAlso: GFH312Participants receive single dose of GFH312 100 mg orally | Drug | SAD:100mg |
| GFH312 200 mgAlso: GFH312Participants receive single dose of GFH312 200 mg orally | Drug | SAD:200mg |
| GFH312 120mgAlso: GFH312Participants receive daily dose of GFH312 120mg orally for fourteen consecutive days | Drug | MAD:120mg |
| PlaceboParticipants receive placebo matching with GFH312 | Other | Placebo |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of GFH312
Time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
The maximum observed plasma concentration (Cmax) was estimated based on the plasma concentrations of GFH312.
Time to peak drug concentration (Tmax) of GFH312
Time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
The time it takes for a drug to reach the maximum concentration (Cmax) after administration of GFH312
Terminal Elimination Half Life (t1/2) of GFH312
Time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of GFH312
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of GFH312
Time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) was estimated based on the plasma concentrations of GFH312
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of GFH312
Time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
The area under the plasma concentration-time curve from time zero to infinity (AUC 0-inf) was estimated based on the plasma concentrations of GFH312
The apparent systemic (or total body) clearance from plasma (or serum or blood (CL/F) following extravascular administration of GFH312
Time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
The systemic clearance (CL) was estimated based on the plasma concentrations of GFH312
The apparent volume of distribution during the terminal elimination phase (Vd/F) following extravascular administration of GFH312
Time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
The volume of distribution was estimated based on the plasma concentrations of GFH312
The observed maximum plasma (or serum or blood) concentration following drug administration at steady state (Cmax,ss)
Time frame: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
Observed maximum concentration in the dosing interval at steady state
The lowest plasma (or serum or blood) concentration observed during a dosing interval at steady state (Cmin,ss)
Time frame: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
Observed minimum concentration in the dosing interval at steady state.
Time to reach maximum concentration in the dosing interval at steady state (Tmax,ss)
Time frame: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
If the same Cmax concentration occurs at different time points, Tmax is assigned to the first occurrence of Cmax.
The area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau (AUCtau,ss)
Time frame: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
Dose-normalized AUC0- τ, calculated as AUC0-τ divided by actual dose administered.
1 secondary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: up to 30 days after the last study drug administration
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 23 Aug 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.
LU Yongning, PHD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 GFH312 100 mg, GFH312 200 mg and GFH312 120mg in people with Healthy Volunteer, run by Zhejiang Genfleet Therapeutics Co., Ltd. at 1 site in China.
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 5 inclusion and 6 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 23 Aug 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 China. 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?
Maximum Observed Plasma Concentration (Cmax) of GFH312 (time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.). The study lists 11 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 23 Aug 2023.