Normal Healthy SubjectsPhase 1NCT05447546
Study to Evaluate HT-6184 in Healthy Subjects
A Phase 1 study testing HT-6184 in people with Normal Healthy Subjects, run by Halia Therapeutics, Inc. at 1 site in United States.
Trial summary
The primary objectives of this study are to evaluate the safety and tolerability of HT-6184 when administered as single oral doses at escalating dose levels in healthy volunteer subjects. The secondary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of HT-6184. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Subjects
- What is being tested?
- HT-6184
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 20 Jul 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is male or female, between 18 and 65 years of age (inclusive) at Screening;
- Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive) at Screening
- Is in good general health, as determined by the Investigator, without clinically significant medical history;
- Normal physical examination, 12-lead electrocardiogram (ECG), and vital signs, as determined by the Investigator;
- Clinical laboratory values within the normal limits as defined by the clinical laboratory reference range;
- Female partners of male participants of childbearing potential, and female participants of childbearing potential must agree to use a highly effective method of contraception prior to study entry, for the duration of study participation, and a minimum of 30 days after the last dose. Highly effective forms of contraception include the following:
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- Established use (i.e., at least 30 days prior to enrollment) of combined (estrogen and progestogen containing) oral, intravaginal or transdermal hormonal contraception associated with inhibition of ovulation,
- Established use (i.e., at least 30 days prior to enrollment) progestogen-only oral, injectable or implantable hormonal contraception associated with inhibition of ovulation,
- Established use (i.e., at least 30 days prior to enrollment) of an intrauterine device (IUD) or intrauterine hormone-releasing system (IUS),
- bilateral tubal occlusion,
- vasectomized partner, provided that partner is the sole sexual partner of the female trial participant and that the vasectomized partner has received medical assessment of the surgical success,
- sexual abstinence, defined as refraining from heterosexual intercourse during the study, when this is in line with the preferred and usual lifestyle of the subject.
- In the case of a female of childbearing potential, has a negative serum pregnancy test (SPT) at Screening and Day -2 and is willing to submit to a SPT at the end of study (EOS);
- Negative urine test for drugs of abuse and breath test for alcohol use at Screening and check-in (Day -2). The tests may be repeated once if necessary and deemed appropriate by the Investigator;
- Agree to refrain from tobacco or nicotine containing products within 48 hours prior to Day 1 and during the periods when PK blood samples are collected;
- Agree to refrain from alcohol consumption within 48 hours prior to Day 1 and during the periods when PK blood samples are collected;
- Agree to refrain from caffeine (i.e., coffee, tea, caffeinated soda, chocolate) within 48 hours prior to Day 1 and during the periods when PK blood samples are collected;
- Agree to refrain from grapefruit, Seville oranges, and pomelo containing products within 72 hours prior to Day 1 and during the periods when PK blood samples are collected; and
- Read, understand, and sign an informed consent.
Who cannot join
- A female who is pregnant, plans to become pregnant during the study, or is breastfeeding a child;
- Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal (GI), endocrinological, respiratory, or metabolic conditions (or history), or other pathological or physiological conditions, that might interfere with the study results in the investigator's opinion;
- Any condition which, in the investigator's opinion, puts the participant at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study;
- Immunization within 10 days of Day 1;
- Anticipated need for surgery or hospitalization during the study;
- Consumed alcohol within 48 hours prior to Day 1 or refuses to abstain from alcohol throughout the duration of the study;
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- History of heavy smoking (i.e., more than 10 cigarettes a day or the tobacco/nicotine equivalent) within 3 months of screening or refuses to abstain from tobacco or nicotine-containing products throughout the duration of the study;
- Donation or loss of blood (excluding volume drawn at screening) of ≥ 450 mL within 3 months of Day 1;
- Active or lifetime infection (e.g., negative test for human immunodeficiency virus (HIV) and hepatitis, and no history of tuberculosis and syphilis) or a history of severe infection during the 30 days prior to screening;
- Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment;
- Prior treatment with a NLRP3 inhibitor for any indication;
- Is unwilling or unable to refrain from using prescription medications for 30 days prior to Day 1 or over the counter medications, herbal preparations, and supplements for 14 days prior to Day 1 (excluding permitted forms of contraception and occasional use of acetaminophen [up to 2 g in 24 hours]);
- Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator;
- Is currently participating in any clinical trial;
- Has received any investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to study Day 1;
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data; and/or
- Inability of the participant (or legally authorized representative) to comprehend the informed consent form (ICF) or unwillingness to sign the ICF.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Center, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HT-6184 in Healthy Human Subjects
The primary objectives of this study are to evaluate the safety and tolerability of HT-6184 when administered as single oral doses at escalating dose levels in healthy volunteer subjects.
The secondary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of HT-6184. Results of the PD analyses will be used to determine the minimal biologically effective dose (MBED): the lowest dose that achieves >70% target inhibition compared to unstimulated vehicle controls over 24 hours in 4 of 6 treated volunteers.
Read the detailed description
This is a phase 1, randomized, placebo-controlled, single-center, single and multiple ascending dose study designed to evaluate the safety, tolerability, PK, and PD of HT-6184.
Each cohort in the study will be comprised of 8 subjects, 6 subjects will receive HT-6184 and 2 subjects will receive placebo. A dose range of 1 mg - 4 mg HT-6184 will be explored in the SAD and MAD escalation cohorts in adult healthy volunteer subjects. Safety and PK data from the 8 completed cohorts will be reviewed.
For the SAD portion subjects will be divided into 4 cohorts of 8 subjects in each cohort. Four (4) ascending single doses (1 dose level per cohort) will be investigated.
Subjects will be screened for eligibility to participate in the study up to 26 days (Day -28) prior to admission to the study center on Day -2. Eligible subjects will be admitted to the study center on Day -2 and will be discharged on Day 2 after all scheduled assessments have been completed. Following discharge, subjects will return to the study center for follow-up visits on Day 7 and receive a follow-up phone call on Day 30.
A modified Fibonacci escalation schedule starting at 1 mg, (escalating by 100%) 2 mg, (escalating by 50%) 3 mg, and (escalating by 33%) 4 mg. The study will have an ongoing assessment of all available safety, tolerability, and concentration data prior to initiation of the next cohort.
For the MAD portion subjects will be divided into 4 cohorts of 8 subjects in each cohort. Four (4) ascending multiple doses (1 dose level per cohort) will be investigated.
Subjects will be screened for eligibility to participate in the study up to 26 days (Day -28) prior to admission to the study center on Day -2. Eligible subjects will be admitted to the study center on Day -2 and will be discharged on Day 13 after all scheduled assessments have been completed. Following discharge, subjects will return to the study center for a follow-up visit on Day 21 and receive a follow-up phone call on Day 42.
- Conditions
- Normal Healthy Subjects
- Being tested
- HT-6184, HT-6184 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HT-6184Drug
Oral capsule
HT-6184 PlaceboDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| 1 mg HT-6184 QD | Active comparator | Cohort 1 - 6 subjects x 1 mg HT-6184 QD on Day 1 Receives: Drug: HT-6184 |
| 1 mg Placebo QD | Placebo comparator | Cohort 1 - 2 subjects x placebo, QD on Day 1 Receives: Drug: HT-6184 Placebo |
| 2 mg HT-6184 QD | Active comparator | Cohort 2 - 6 subjects x 2 mg HT-6184 QD on Day 1 Receives: Drug: HT-6184 |
| 2 mg Placebo QD | Placebo comparator | Cohort 2 - 2 subjects x placebo, QD on Day 1 Receives: Drug: HT-6184 Placebo |
| 3 mg HT-6184 QD | Active comparator | Cohort 3 - 6 subjects x 3 mg HT-6184 QD on Day 1 Receives: Drug: HT-6184 |
| 3 mg Placebo QD | Placebo comparator | Cohort 3 - 2 subjects x placebo, QD on Day 1 Receives: Drug: HT-6184 Placebo |
| 4 mg HT-6184 QD | Active comparator | Cohort 4 - 6 subjects x 4 mg HT-6184 QD on Day 1 Receives: Drug: HT-6184 |
| 4 mg Placebo QD | Placebo comparator | Cohort 4 - 2 subjects x placebo, QD on Day 1 Receives: Drug: HT-6184 Placebo |
| 1 mg HT-6184 QD x 2 weeks | Active comparator | Cohort 5 - 6 subjects x 1 mg HT-6184 QD on Day 1-5, 8-12 Receives: Drug: HT-6184 |
| 1 mg Placebo QD x 2 weeks | Placebo comparator | Cohort 5 - 2 subjects x 1 mg placebo, QD on Day 1-5, 8-12 Receives: Drug: HT-6184 Placebo |
| 2 mg HT-6184 QD x 2 weeks | Active comparator | Cohort 6 - 6 subjects x 2 mg HT-6184 QD on Day 1-5, 8-12 Receives: Drug: HT-6184 |
| 2 mg Placebo QD x 2 weeks | Placebo comparator | Cohort 6 - 2 subjects x 2 mg placebo, QD on Day 1-5, 8-12 Receives: Drug: HT-6184 Placebo |
| 3 mg HT-6184 QD x 2 weeks | Active comparator | Cohort 7 - 6 subjects x 3 mg HT-6184 QD on Day 1-5, 8-12 Receives: Drug: HT-6184 |
| 3 mg Placebo QD x 2 weeks | Placebo comparator | Cohort 7 - 2 subjects x 3 mg placebo, QD on Day 1-5, 8-12 Receives: Drug: HT-6184 Placebo |
| 4 mg HT-6184 QD x 2 weeks | Active comparator | Cohort 8 - 6 subjects x 4 mg HT-6184 QD on Day 1-5, 8-12 Receives: Drug: HT-6184 |
| 4 mg Placebo QD x 2 weeks | Placebo comparator | Cohort 8 - 2 subjects x 4 mg placebo, QD on Day 1-5, 8-12 Receives: Drug: HT-6184 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events administered as single oral doses at escalating dose levels in healthy volunteer subjects.
Safety and tolerability of HT-6184 as measured by subject incidence of treatment-related adverse events.
Measured: up to 6 weeks
Incidence of abnormal laboratory test results
Safety and tolerability of HT-6184 as measured by subject incidence of treatment-related abnormal lab values.
Measured: up to 6 weeks
Incidence of treatment-emergent clinically abnormal electrocardiogram (ECG)
Safety and tolerability of HT-6184 as measured by subject incidence of treatment-related abnormal ECG.
Measured: up to 6 weeks
Incidence of treatment-emergent clinically abnormal physical exam
Safety and tolerability of HT-6184 as measured by subject incidence of treatment-related abnormal physical exam.
Measured: up to 6 weeks
Secondary outcomes (9)
Plasma maximum measured drug concentration (Cmax)
Cmax will be reported.
Measured: up to 6 weeks
Time of maximum concentration (Tmax)
Tmax will be reported.
Measured: up to 6 weeks
Area under the plasma concentration-time curve (AUC0-24)
Area under the plasma concentration-time curve from 0 until 24 hours post-dose will be reported.
Measured: up to 6 weeks
Area under the plasma concentration-time curve (AUC0-last)
Area under the plasma concentration-time curve, from 0 to the last quantifiable timepoint will be reported.
Measured: up to 6 weeks
Area under the plasma concentration-time curve (AUC0-inf)
Area under the plasma concentration-time curve, from 0 to infinity will be reported.
Measured: up to 6 weeks
Plasma half-life (T½)
T½ will be reported.
Measured: up to 6 weeks
Terminal elimination rate constant (kel)
Terminal elimination rate constant will be reported.
Measured: up to 6 weeks
Apparent clearance (CL/F)
CL/F will be reported.
Measured: up to 6 weeks
Apparent volume of distribution at steady state (Vss/F)
Vss/F will be reported.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start15 Jun 2022
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Healthy SubjectsStudies 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
- SAD portion in 4 cohorts, with 8 subjects in each cohort, 4 ascending single doses, MAD portion in 4 cohorts, with 8 subjects in each cohort, 4 multiple ascending doses.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halia Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Jesson Yeh, MD, Principal investigator, TKL Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447546
- Sponsor's protocol ID
- HT-6184-NHV-001
- Status last verified
- Aug 2023
- First submitted
- 19 May 2022
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HT-6184 in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT05447546
- Acronym / sponsor ID
- HT-6184-NHV-001
- Conditions
- Normal Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Halia Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 7 Jul 2022 (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 primary objectives of this study are to evaluate the safety and tolerability of HT-6184 when administered as single oral doses at escalating dose levels in healthy volunteer subjects.
The secondary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of HT-6184. Results of the PD analyses will be used to determine the minimal biologically effective dose (MBED): the lowest dose that achieves >70% target inhibition compared to unstimulated vehicle controls over 24 hours in 4 of 6 treated volunteers.
Detailed description
This is a phase 1, randomized, placebo-controlled, single-center, single and multiple ascending dose study designed to evaluate the safety, tolerability, PK, and PD of HT-6184.
Each cohort in the study will be comprised of 8 subjects, 6 subjects will receive HT-6184 and 2 subjects will receive placebo. A dose range of 1 mg - 4 mg HT-6184 will be explored in the SAD and MAD escalation cohorts in adult healthy volunteer subjects. Safety and PK data from the 8 completed cohorts will be reviewed.
For the SAD portion subjects will be divided into 4 cohorts of 8 subjects in each cohort. Four (4) ascending single doses (1 dose level per cohort) will be investigated.
Subjects will be screened for eligibility to participate in the study up to 26 days (Day -28) prior to admission to the study center on Day -2. Eligible subjects will be admitted to the study center on Day -2 and will be discharged on Day 2 after all scheduled assessments have been completed. Following discharge, subjects will return to the study center for follow-up visits on Day 7 and receive a follow-up phone call on Day 30.
A modified Fibonacci escalation schedule starting at 1 mg, (escalating by 100%) 2 mg, (escalating by 50%) 3 mg, and (escalating by 33%) 4 mg. The study will have an ongoing assessment of all available safety, tolerability, and concentration data prior to initiation of the next cohort.
For the MAD portion subjects will be divided into 4 cohorts of 8 subjects in each cohort. Four (4) ascending multiple doses (1 dose level per cohort) will be investigated.
Subjects will be screened for eligibility to participate in the study up to 26 days (Day -28) prior to admission to the study center on Day -2. Eligible subjects will be admitted to the study center on Day -2 and will be discharged on Day 13 after all scheduled assessments have been completed. Following discharge, subjects will return to the study center for a follow-up visit on Day 21 and receive a follow-up phone call on Day 42.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 16
- Model description
- SAD portion in 4 cohorts, with 8 subjects in each cohort, 4 ascending single doses, MAD portion in 4 cohorts, with 8 subjects in each cohort, 4 multiple ascending doses.
| Arm | Type | Receives |
|---|---|---|
| 1 mg HT-6184 QD | Active comparator | Drug: HT-6184Cohort 1 - 6 subjects x 1 mg HT-6184 QD on Day 1 |
| 1 mg Placebo QD | Placebo comparator | Drug: HT-6184 PlaceboCohort 1 - 2 subjects x placebo, QD on Day 1 |
| 2 mg HT-6184 QD | Active comparator | Drug: HT-6184Cohort 2 - 6 subjects x 2 mg HT-6184 QD on Day 1 |
| 2 mg Placebo QD | Placebo comparator | Drug: HT-6184 PlaceboCohort 2 - 2 subjects x placebo, QD on Day 1 |
| 3 mg HT-6184 QD | Active comparator | Drug: HT-6184Cohort 3 - 6 subjects x 3 mg HT-6184 QD on Day 1 |
| 3 mg Placebo QD | Placebo comparator | Drug: HT-6184 PlaceboCohort 3 - 2 subjects x placebo, QD on Day 1 |
| 4 mg HT-6184 QD | Active comparator | Drug: HT-6184Cohort 4 - 6 subjects x 4 mg HT-6184 QD on Day 1 |
| 4 mg Placebo QD | Placebo comparator | Drug: HT-6184 PlaceboCohort 4 - 2 subjects x placebo, QD on Day 1 |
| 1 mg HT-6184 QD x 2 weeks | Active comparator | Drug: HT-6184Cohort 5 - 6 subjects x 1 mg HT-6184 QD on Day 1-5, 8-12 |
| 1 mg Placebo QD x 2 weeks | Placebo comparator | Drug: HT-6184 PlaceboCohort 5 - 2 subjects x 1 mg placebo, QD on Day 1-5, 8-12 |
| 2 mg HT-6184 QD x 2 weeks | Active comparator | Drug: HT-6184Cohort 6 - 6 subjects x 2 mg HT-6184 QD on Day 1-5, 8-12 |
| 2 mg Placebo QD x 2 weeks | Placebo comparator | Drug: HT-6184 PlaceboCohort 6 - 2 subjects x 2 mg placebo, QD on Day 1-5, 8-12 |
| 3 mg HT-6184 QD x 2 weeks | Active comparator | Drug: HT-6184Cohort 7 - 6 subjects x 3 mg HT-6184 QD on Day 1-5, 8-12 |
| 3 mg Placebo QD x 2 weeks | Placebo comparator | Drug: HT-6184 PlaceboCohort 7 - 2 subjects x 3 mg placebo, QD on Day 1-5, 8-12 |
| 4 mg HT-6184 QD x 2 weeks | Active comparator | Drug: HT-6184Cohort 8 - 6 subjects x 4 mg HT-6184 QD on Day 1-5, 8-12 |
| 4 mg Placebo QD x 2 weeks | Placebo comparator | Drug: HT-6184 PlaceboCohort 8 - 2 subjects x 4 mg placebo, QD on Day 1-5, 8-12 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Is male or female, between 18 and 65 years of age (inclusive) at Screening;
- Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive) at Screening
- Is in good general health, as determined by the Investigator, without clinically significant medical history;
- Normal physical examination, 12-lead electrocardiogram (ECG), and vital signs, as determined by the Investigator;
- Clinical laboratory values within the normal limits as defined by the clinical laboratory reference range;
Key exclusion criteria (17 listed)
- A female who is pregnant, plans to become pregnant during the study, or is breastfeeding a child;
- Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal (GI), endocrinological, respiratory, or metabolic conditions (or history), or other pathological or physiological conditions, that might interfere with the study results in the investigator's opinion;
- Any condition which, in the investigator's opinion, puts the participant at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study;
- Immunization within 10 days of Day 1;
- Anticipated need for surgery or hospitalization during 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 |
|---|---|---|
| HT-6184Oral capsule | Drug | 1 mg HT-6184 QD, 1 mg HT-6184 QD x 2 weeks, 2 mg HT-6184 QD, 2 mg HT-6184 QD x 2 weeks, 3 mg HT-6184 QD, 3 mg HT-6184 QD x 2 weeks, 4 mg HT-6184 QD, 4 mg HT-6184 QD x 2 weeks |
| HT-6184 PlaceboOral capsule | Drug | 1 mg Placebo QD, 1 mg Placebo QD x 2 weeks, 2 mg Placebo QD, 2 mg Placebo QD x 2 weeks, 3 mg Placebo QD, 3 mg Placebo QD x 2 weeks, 4 mg Placebo QD, 4 mg Placebo QD x 2 weeks |
Primary outcome
Incidence of adverse events administered as single oral doses at escalating dose levels in healthy volunteer subjects.
Time frame: up to 6 weeks
Safety and tolerability of HT-6184 as measured by subject incidence of treatment-related adverse events.
Incidence of abnormal laboratory test results
Time frame: up to 6 weeks
Safety and tolerability of HT-6184 as measured by subject incidence of treatment-related abnormal lab values.
Incidence of treatment-emergent clinically abnormal electrocardiogram (ECG)
Time frame: up to 6 weeks
Safety and tolerability of HT-6184 as measured by subject incidence of treatment-related abnormal ECG.
Incidence of treatment-emergent clinically abnormal physical exam
Time frame: up to 6 weeks
Safety and tolerability of HT-6184 as measured by subject incidence of treatment-related abnormal physical exam.
9 secondary outcomes
Plasma maximum measured drug concentration (Cmax)
Time frame: up to 6 weeks
Time of maximum concentration (Tmax)
Time frame: up to 6 weeks
Area under the plasma concentration-time curve (AUC0-24)
Time frame: up to 6 weeks
Area under the plasma concentration-time curve (AUC0-last)
Time frame: up to 6 weeks
Area under the plasma concentration-time curve (AUC0-inf)
Time frame: up to 6 weeks
Plasma half-life (T½)
Time frame: up to 6 weeks
Terminal elimination rate constant (kel)
Time frame: up to 6 weeks
Apparent clearance (CL/F)
Time frame: up to 6 weeks
Apparent volume of distribution at steady state (Vss/F)
Time frame: up to 6 weeks
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 28 Aug 2023.
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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.
Jesson Yeh, MD principal investigator
TKL Research, Inc.
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 HT-6184 in people with Normal Healthy Subjects, run by Halia Therapeutics, Inc. 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 19 inclusion and 17 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 28 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 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?
Incidence of adverse events administered as single oral doses at escalating dose levels in healthy volunteer subjects. (time frame: up to 6 weeks). The study lists 4 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 28 Aug 2023.