Normal Healthy SubjectsPhase 1NCT06537817
Study to Evaluate HT-4253 in Healthy Subjects
A Phase 1 study testing HT-4253 in people with Normal Healthy Subjects, run by Halia Therapeutics, Inc. at 1 site in Australia.
Trial summary
The primary objectives of this study are to evaluate the safety and tolerability of HT-4253 when administered as single oral doses and multiple oral doses at escalating dose levels in healthy volunteer subjects. 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-4253
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Sep 2024to 12 May 2025
- 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
- Age is ≥ 18 years to 65 years
- Body mass index between 18 and 32 kg/m2
- Female subjects must be surgically sterile or post menopausal for at least 12 months. Females may be of child-bearing potential but must use double contraception.
Who cannot join
- Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal, endocrinological, respiratory, or metabolic conditions (or history), or other pathological or physiological conditions,
- History of suicidal behavior and/or ongoing suicidal ideation per C-SSRS evaluation when screening
- Use of any medications, including prescription, over-the-counter (OTC) medications, vitamins, herbal preparations, and supplements
- Positive drug screen or alcohol breath tests
- History of heavy smoking 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
- Clinical significant abnormalities in laboratory test results
- Chronic or current active infectious disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, First-in-Human, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) of Oral HT-4253 in Healthy Adults
The primary objectives of this study are to evaluate the safety and tolerability of HT-4253 when administered as single oral doses and multiple 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-4253.
- Conditions
- Normal Healthy Subjects
- Being tested
- HT-4253, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HT-4253Drug
HT-4253 Single or Multiple doses administered orally as a tablet
PlaceboDrug
Placebo to match HT-4253 Single or Multiple doses administered orally as a tablet
| Study group | Role | What they receive |
|---|---|---|
| HT-4253 | Experimental | Subjects will participate in 1 of 10 groups and receive single or multiple doses of HT-4253 or matching placebo. In each group 6 subjects will receive HT-4253. Receives: Drug: HT-4253 |
| Placebo to match HT-4253 | Placebo comparator | Subjects will participate in 1 of 10 groups and receive single or multiple doses of HT-4253 or matching placebo. In each group 2 subjects will receive matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults
Incidence of adverse events (AEs)
Measured: up to 6 weeks
To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults
Serious adverse events (SAEs)
Measured: up to 6 weeks
To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults
Treatment-related adverse events (TRAEs)
Measured: up to 6 weeks
To evaluate the safety and tolerability of single and multiple ascending
Incidence of withdrawals due to AE
Measured: up to 6 weeks
Secondary outcomes (4)
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
Maximum plasma concentration (Cmax)
Measured: up to 6 weeks
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
Area under the concentration-time curve (AUC)
Measured: up to 6 weeks
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
Elimination half-life (t1/2) plasma concentration of HT-4253
Measured: up to 6 weeks
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
Trough plasma concentration of HT-4253
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 posted5 Aug 2024
- Study start17 Sep 2024
- Primary completion12 May 2025
- Study completion12 May 2025
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halia Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537817
- Sponsor's protocol ID
- HT-4253-NHV-001
- Status last verified
- Jun 2025
- First submitted
- 30 Jul 2024
- Last updated
- 11 Jun 2025
- 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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) of Oral HT-4253 in Healthy Adults
- ClinicalTrials.gov ID
- NCT06537817
- Acronym / sponsor ID
- HT-4253-NHV-001
- Conditions
- Normal Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Halia Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 5 Aug 2024 (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-4253 when administered as single oral doses and multiple 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-4253.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HT-4253 | Experimental | Drug: HT-4253Subjects will participate in 1 of 10 groups and receive single or multiple doses of HT-4253 or matching placebo. In each group 6 subjects will receive HT-4253. |
| Placebo to match HT-4253 | Placebo comparator | Drug: PlaceboSubjects will participate in 1 of 10 groups and receive single or multiple doses of HT-4253 or matching placebo. In each group 2 subjects will receive matching placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age is ≥ 18 years to 65 years
- Body mass index between 18 and 32 kg/m2
- Female subjects must be surgically sterile or post menopausal for at least 12 months. Females may be of child-bearing potential but must use double contraception.
Key exclusion criteria (7 listed)
- Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal, endocrinological, respiratory, or metabolic conditions (or history), or other pathological or physiological conditions,
- History of suicidal behavior and/or ongoing suicidal ideation per C-SSRS evaluation when screening
- Use of any medications, including prescription, over-the-counter (OTC) medications, vitamins, herbal preparations, and supplements
- Positive drug screen or alcohol breath tests
- History of heavy smoking 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
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-4253HT-4253 Single or Multiple doses administered orally as a tablet | Drug | HT-4253 |
| PlaceboPlacebo to match HT-4253 Single or Multiple doses administered orally as a tablet | Drug | Placebo to match HT-4253 |
Primary outcome
To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults
Time frame: up to 6 weeks
Incidence of adverse events (AEs)
To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults
Time frame: up to 6 weeks
Serious adverse events (SAEs)
To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults
Time frame: up to 6 weeks
Treatment-related adverse events (TRAEs)
To evaluate the safety and tolerability of single and multiple ascending
Time frame: up to 6 weeks
Incidence of withdrawals due to AE
4 secondary outcomes
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
Time frame: up to 6 weeks
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
Time frame: up to 6 weeks
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
Time frame: up to 6 weeks
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
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 11 Jun 2025.
- 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 HT-4253 in people with Normal Healthy Subjects, run by Halia Therapeutics, Inc. at 1 site in Australia.
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 7 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 11 Jun 2025. 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 Australia. 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?
To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults (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 11 Jun 2025; AzTrials last refreshed its copy on 3 Nov 2026.