IPFPhase 1NCT05803850
A Study to Evaluate the Safety, Tolerability, PK and PD of HNC1058
A Phase 1 study testing HNC1058 Capsules in people with IPF, run by Guangzhou Henovcom Bioscience Co. Ltd. at 1 site in United States.
Trial summary
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of HNC1058 given to healthy subjects, compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- IPF
- What is being tested?
- HNC1058 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2023to 8 Mar 2024
- 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
- Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements, and restrictions of the study. Are capable of giving informed consent and complying with study procedures.
- Between the ages of 18 and 55 years (inclusive) at the time of Screening.
- BMI between 18.0 and 32.0 kg/m2 (inclusive) at the time of Screening and have a body weight no less than 50 kg.
- In good general health, as determined by the Investigator.
- Female subjects must be non pregnant and non lactating.
- Female subjects must be of non childbearing potential, or agree to use an appropriate method(s) of contraception throughout the entire duration of study participation, and have negative pregnancy test results at Screening (serum) and Admission (urine).
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- Refer to Section 6.4.1 for full details of reproductive requirements and acceptable methods of contraception for female subjects.
- Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) plus an additional barrier method (female partner) of contraception for the duration of the study and for at least 90 days after dosing; must also agree to refrain from sperm donation for at least 90 days post dose.
- Normal renal function as determined by Investigator following review of clinical laboratory test results, including eGFR as estimated using the CKD EPI equation.
- Non smoker, with no use of any tobacco or nicotine containing products within 6 months prior to Day 1.
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.
- Known or suspected malignancy.
- History of pancreatitis or gall stones.
- History of unexplained syncope, symptomatic hypotension, or hypoglycemia.
- Family history of long QTc syndrome.
- History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance.
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- Poor venous access.
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or hepatitis E.
- Hospital admission or major surgery within 6 months prior to screening.
- History of alcohol or prescription drug abuse within 9 months prior to screening.
- Positive test result for alcohol or drugs of abuse (i.e., UDS) at screening or Admission.
- Use of any prohibited medication(s) and/or substance(s), including:
- use of any drugs known to induce or inhibit drug metabolism within 30 days prior to Day 1;
- receipt of another investigational medication (EXCEPT biological compound) within 30 days or receipt of biological compound within 90 days (or 5 half lives, whichever is longer) prior to Day 1;
- participation in an investigational device study within 30 days prior to Day 1.
- routine consumption of the following within 14 days prior to Day 1:
- Prescription medication (except hormonal contraception for WOCBP), OTC medication, traditional Chinese medicine, or herbal medicine (within 14 days or 5 half lives, whichever is longer); ii. Vitamin, mineral, and other dietary supplements; iii. Grapefruit and grapefruit juice; e. donation of the following within the below specified timeframe prior to Day 1: i. bone marrow or peripheral stem cells within 90 days; ii. blood within 60 days; iii. plasma within 30 days. f. Any of the following activities within 72 hours prior to Day 1: i. strenuous exercise; ii. alcohol consumption; iii. consumption of caffeine-containing substances.
- Loss of >500 mL blood (for any reason) within 90 days prior to Day 1.
- For 50 mg cohort only: inability to completely consume a standardized high fat breakfast within 30 minutes.
- Per investigator discretion, any other reason that would render a subject inappropriate for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Doses (SAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of HNC1058
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of HNC1058 given to healthy subjects, compared to placebo.
- Conditions
- IPF
- Being tested
- HNC1058 Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HNC1058 CapsulesDrug
Also called HNC1058 Placebos
HNC1058 Capsules/Placebos, single dose, PO, starting dose of 10 mg escalating up to 80 mg；HNC1058 Capsules/Placebos, 50 mg, single dose, FED.
| Study group | Role | What they receive |
|---|---|---|
| HNC1058 Capsules | Experimental | HNC1058 Capsules, single ascending doses Receives: Drug: HNC1058 Capsules |
| HNC1058 Placebos | Placebo comparator | HNC1058 Placebos, single ascending doses Receives: Drug: HNC1058 Capsules |
| HNC1058 Capsules FED | Experimental | HNC1058 Capsules, food effect, Single dose Receives: Drug: HNC1058 Capsules |
| HNC1058 Placebos FED | Placebo comparator | HNC1058 Placebos, food effect, Single dose Receives: Drug: HNC1058 Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events and concomitant medications
To evaluate the safety and tolerability of HNC1058 in comparison with placebo after a single oral dose in healthy subjects in terms of AEs and CMs.
Measured: Between screening and 7-9 days after the last dose
Secondary outcomes (2)
Number of subjects with vital sign measurements
To evaluate the safety and tolerability of HNC1058 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal vital signs
Measured: Between screening and 7-9 days after the last dose
Number of subjects with clinical laboratory test results
- evaluate the safety and tolerability of HNC1058 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal clinical laboratory test results
Measured: Between screening and 7-9 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start28 Mar 2023
- Primary completion27 Feb 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies 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
- Sequential Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803850
- Sponsor's protocol ID
- HNC1058-A101
- Status last verified
- Mar 2024
- First submitted
- 23 Mar 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Ascending Doses (SAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of HNC1058
- ClinicalTrials.gov ID
- NCT05803850
- Acronym / sponsor ID
- HNC1058-A101
- Conditions
- IPF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 7 Apr 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 purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of HNC1058 given to healthy subjects, compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Sequential Assignment
| Arm | Type | Receives |
|---|---|---|
| HNC1058 Capsules | Experimental | Drug: HNC1058 CapsulesHNC1058 Capsules, single ascending doses |
| HNC1058 Placebos | Placebo comparator | Drug: HNC1058 CapsulesHNC1058 Placebos, single ascending doses |
| HNC1058 Capsules FED | Experimental | Drug: HNC1058 CapsulesHNC1058 Capsules, food effect, Single dose |
| HNC1058 Placebos FED | Placebo comparator | Drug: HNC1058 CapsulesHNC1058 Placebos, food effect, Single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements, and restrictions of the study. Are capable of giving informed consent and complying with study procedures.
- Between the ages of 18 and 55 years (inclusive) at the time of Screening.
- BMI between 18.0 and 32.0 kg/m2 (inclusive) at the time of Screening and have a body weight no less than 50 kg.
- In good general health, as determined by the Investigator.
- Female subjects must be non pregnant and non lactating.
Key exclusion criteria (20 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.
- Known or suspected malignancy.
- History of pancreatitis or gall stones.
- History of unexplained syncope, symptomatic hypotension, or hypoglycemia.
- Family history of long QTc syndrome.
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 |
|---|---|---|
| HNC1058 CapsulesAlso: HNC1058 PlacebosHNC1058 Capsules/Placebos, single dose, PO, starting dose of 10 mg escalating up to 80 mg；HNC1058 Capsules/Placebos, 50 mg, single dose, FED. | Drug | HNC1058 Capsules, HNC1058 Capsules FED, HNC1058 Placebos, HNC1058 Placebos FED |
Primary outcome
Number of subjects with adverse events and concomitant medications
Time frame: Between screening and 7-9 days after the last dose
To evaluate the safety and tolerability of HNC1058 in comparison with placebo after a single oral dose in healthy subjects in terms of AEs and CMs.
2 secondary outcomes
Number of subjects with vital sign measurements
Time frame: Between screening and 7-9 days after the last dose
Number of subjects with clinical laboratory test results
Time frame: Between screening and 7-9 days after the last dose
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 21 Mar 2024.
- 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.
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 HNC1058 Capsules in people with IPF, run by Guangzhou Henovcom Bioscience 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 10 inclusion and 20 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 21 Mar 2024. 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. 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?
Number of subjects with adverse events and concomitant medications (time frame: Between screening and 7-9 days after the last dose). 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 21 Mar 2024.