HealthyPhase 1NCT04480697
Study of Safety, Tolerability and PK, PD of HPG1860 in Healthy Subjects
A Phase 1 study testing HPG1860 in people with Healthy, run by Hepagene (Shanghai) Co., Ltd. at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase 1study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of HPG1860 orally administered in healthy 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
- What is being tested?
- HPG1860
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 7 Aug 2021
- 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
- Healthy subjects aged 18-55 years old (inclusive), male or female
- Females must be of non-childbearing potential
- Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive) and weigh at least 50 kg at time of Screening
Who cannot join
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator
- Taken an investigational drug within 3 months or 5 half-live, whichever is longer from the Screening date
- Any liver function panel analyte (LFT) value > upper limits of normal reference range
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B core (IgG and IgM) and surface antigen (HBsAg), Hepatitis A antibody (IgM), hepatitis C antibody (IgG), or hepatitis E (IgG and IgM) at Screening
- Any condition or finding that in the opinion of the Principal Investigator or designee would put the subject or study conduct at risk if the subject were to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Single and Multiple Ascending Doses (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HPG1860
This is a randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase 1study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of HPG1860 orally administered in healthy subjects.
Read the detailed description
In SAD and MAD studies, all subjects are randomized in a 3:1 ratio. In SAD study , there are 6 cohorts (8 subjects/cohort) with dose levels of 10mg, 20 mg, 40 mg, 80 mg, 120 mg and 150 mg respectively. Blood samples will be collected for safety, PK and PD assessments. After the completion of Cohort 2 (20 mg) in SAD study, following a 7-day washout period, the same 8 subjects will receive another single oral dose of 20 mg HPG1860 after a standard high fat/high calorie breakfast (the fed condition). PK blood samplings will be collected and Cmax and AUC will be used for assessing the food effect. In MAD study, there are 3 cohorts (8 subjects/cohort) with dose levels of 10mg, 30mg and 90 mg, respectively and dosing regimen is once daily for 14 consecutive days. Blood samples will be collected for safety, PK and PD assessments.
- Conditions
- Healthy
- Being tested
- HPG1860
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPG1860Drug
6 subjects randomized to active compound and 2 subjects randomized to placebo
| Study group | Role | What they receive |
|---|---|---|
| SAD 10mg | Experimental | A single oral dose of 10 mg Receives: Drug: HPG1860 |
| SAD 20mg | Experimental | A single oral dose of 20 mg. Food effect will also be assessed at the same dose level. Receives: Drug: HPG1860 |
| SAD 40mg | Experimental | A single oral dose of 40mg Receives: Drug: HPG1860 |
| SAD 80 mg | Experimental | A single oral dose of 80 mg Receives: Drug: HPG1860 |
| SAD 120 mg | Experimental | A single oral dose of 120 mg Receives: Drug: HPG1860 |
| SAD 150 mg | Experimental | A single oral dose of 150 mg Receives: Drug: HPG1860 |
| MAD 10mg | Experimental | Dose regimen is once daily 10 mg for 14 consecutive days. Receives: Drug: HPG1860 |
| MAD 30mg | Experimental | Dose regimen is once daily 30 mg for 14 consecutive days. Receives: Drug: HPG1860 |
| MAD 90 mg | Experimental | Dose regimen is once daily 90mg for 14 consecutive days. Receives: Drug: HPG1860 |
What is being measured
The primary outcome is the main question the study is designed to answer.
After single ascending doses, number of subjects with treatment-emergent adverse events(TEAEs) in the HPG1860 dose-level cohorts
To investigate the safety and tolerability of orally administered SAD of HPG1860 by assessment of AEs, vital signs and clinical laboratory findings.
Measured: Day1-8
After multiple ascending doses, number of subjects with treatment-emergent adverse events(TEAEs) in the HPG1860 dose-level cohorts
To investigate the safety and tolerability of orally administered MAD of HPG1860 by assessment of AEs, vital signs and clinical laboratory findings.
Measured: Day1-21
Secondary outcomes (10)
Effect of HPG1860 on Blood Concentration of FGF19 and 7-alpha-hydroxy-4-cholesten-3-one (C4)
To assess blood FGF19 and C4 changes vs placebo after orally administered SAD and MAD of HPG1860
Measured: SAD: Day 1. MAD: Day 1 and Day14
Cmax
Maximum observed serum concentration
Measured: SAD: up to 48 hours ; MAD: up to 14 days.
Tmax
Time to reach Cmax
Measured: SAD: up to 48 hours ; MAD: up to 14 days.
AUClast
Area under the curve from the time of dosing to the time of the last measurable concentration
Measured: SAD: up to 48 hours ; MAD: up to 14 days.
AUCinf
Area under the curve from the time of dosing extrapolated to infinity
Measured: SAD: up to 48 hours ; MAD: up to 14 days.
CL
Apparent total body clearance of the drug from plasma
Measured: SAD: up to 48 hours; MAD: up to 14 days
Vd
Apparent volume of distribution
Measured: SAD: up to 48 hours; MAD: up to 14 days
Effect of Food on Cmax of HPG1860
To assess the effect of food on a single dose of 20 mg HPG1860 by evaluating Cmax
Measured: up to 48 hours
Effect of Food on AUCinf of HPG1860
To assess the effect of food on a single dose of 20 mg HPG1860 by evaluating AUCinf
Measured: up to 48 hours
Effect of Food on AUC0-24h of HPG1860
To assess the effect of food on a single dose of 20 mg HPG1860 by evaluating AUC0-24h
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 posted21 Jul 2020
- Study start23 Sep 2019
- Primary completion25 Nov 2020
- Study completion7 Aug 2021
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
- Model description
- Part 1 SAD: 6 cohorts Part 2 MAD: 3 cohorts
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepagene (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480697
- Sponsor's protocol ID
- HPG1860-101
- Status last verified
- Apr 2022
- First submitted
- 14 Jul 2020
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. 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 Doses (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HPG1860
- ClinicalTrials.gov ID
- NCT04480697
- Acronym / sponsor ID
- HPG1860-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hepagene (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 7 Aug 2021 (actual)
- First posted
- 21 Jul 2020 (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 ascending dose Phase 1study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of HPG1860 orally administered in healthy subjects.
Detailed description
In SAD and MAD studies, all subjects are randomized in a 3:1 ratio. In SAD study , there are 6 cohorts (8 subjects/cohort) with dose levels of 10mg, 20 mg, 40 mg, 80 mg, 120 mg and 150 mg respectively. Blood samples will be collected for safety, PK and PD assessments. After the completion of Cohort 2 (20 mg) in SAD study, following a 7-day washout period, the same 8 subjects will receive another single oral dose of 20 mg HPG1860 after a standard high fat/high calorie breakfast (the fed condition). PK blood samplings will be collected and Cmax and AUC will be used for assessing the food effect. In MAD study, there are 3 cohorts (8 subjects/cohort) with dose levels of 10mg, 30mg and 90 mg, respectively and dosing regimen is once daily for 14 consecutive days. Blood samples will be collected for safety, PK and PD assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
- Model description
- Part 1 SAD: 6 cohorts Part 2 MAD: 3 cohorts
| Arm | Type | Receives |
|---|---|---|
| SAD 10mg | Experimental | Drug: HPG1860A single oral dose of 10 mg |
| SAD 20mg | Experimental | Drug: HPG1860A single oral dose of 20 mg. Food effect will also be assessed at the same dose level. |
| SAD 40mg | Experimental | Drug: HPG1860A single oral dose of 40mg |
| SAD 80 mg | Experimental | Drug: HPG1860A single oral dose of 80 mg |
| SAD 120 mg | Experimental | Drug: HPG1860A single oral dose of 120 mg |
| SAD 150 mg | Experimental | Drug: HPG1860A single oral dose of 150 mg |
| MAD 10mg | Experimental | Drug: HPG1860Dose regimen is once daily 10 mg for 14 consecutive days. |
| MAD 30mg | Experimental | Drug: HPG1860Dose regimen is once daily 30 mg for 14 consecutive days. |
| MAD 90 mg | Experimental | Drug: HPG1860Dose regimen is once daily 90mg for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects aged 18-55 years old (inclusive), male or female
- Females must be of non-childbearing potential
- Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive) and weigh at least 50 kg at time of Screening
Key exclusion criteria (5 listed)
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator
- Taken an investigational drug within 3 months or 5 half-live, whichever is longer from the Screening date
- Any liver function panel analyte (LFT) value > upper limits of normal reference range
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B core (IgG and IgM) and surface antigen (HBsAg), Hepatitis A antibody (IgM), hepatitis C antibody (IgG), or hepatitis E (IgG and IgM) at Screening
- Any condition or finding that in the opinion of the Principal Investigator or designee would put the subject or study conduct at risk if the subject were to participate in 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 |
|---|---|---|
| HPG18606 subjects randomized to active compound and 2 subjects randomized to placebo | Drug | MAD 10mg, MAD 30mg, MAD 90 mg, SAD 10mg, SAD 120 mg, SAD 150 mg, SAD 20mg, SAD 40mg, SAD 80 mg |
Primary outcome
After single ascending doses, number of subjects with treatment-emergent adverse events(TEAEs) in the HPG1860 dose-level cohorts
Time frame: Day1-8
To investigate the safety and tolerability of orally administered SAD of HPG1860 by assessment of AEs, vital signs and clinical laboratory findings.
After multiple ascending doses, number of subjects with treatment-emergent adverse events(TEAEs) in the HPG1860 dose-level cohorts
Time frame: Day1-21
To investigate the safety and tolerability of orally administered MAD of HPG1860 by assessment of AEs, vital signs and clinical laboratory findings.
10 secondary outcomes
Effect of HPG1860 on Blood Concentration of FGF19 and 7-alpha-hydroxy-4-cholesten-3-one (C4)
Time frame: SAD: Day 1. MAD: Day 1 and Day14
Cmax
Time frame: SAD: up to 48 hours ; MAD: up to 14 days.
Tmax
Time frame: SAD: up to 48 hours ; MAD: up to 14 days.
AUClast
Time frame: SAD: up to 48 hours ; MAD: up to 14 days.
AUCinf
Time frame: SAD: up to 48 hours ; MAD: up to 14 days.
CL
Time frame: SAD: up to 48 hours; MAD: up to 14 days
Vd
Time frame: SAD: up to 48 hours; MAD: up to 14 days
Effect of Food on Cmax of HPG1860
Time frame: up to 48 hours
Effect of Food on AUCinf of HPG1860
Time frame: up to 48 hours
Effect of Food on AUC0-24h of HPG1860
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 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 HPG1860 in people with Healthy, run by Hepagene (Shanghai) Co., Ltd. at 1 site in United States.
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 5 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 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 United States. 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?
After single ascending doses, number of subjects with treatment-emergent adverse events(TEAEs) in the HPG1860 dose-level cohorts (time frame: Day1-8). 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 25 Apr 2022.