PainPhase 2NCT06241742
Evaluating Ability of HT-6184 to Reduce Inflammation and Pain After Third Molar Extraction
A Phase 2 study testing HT-6184 in people with Pain, run by Halia Therapeutics, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the ability of HT-6184 to decrease inflammation and pain in patients after third molar removal. The main question it aims to answer are: Does HT-6184 decrease inflammation in patients after third molar removal? Does HT-6184 decrease pain in patients after third molar removal?… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- 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
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to 30 Apr 2024
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The candidate is 18 years of age or older, capable of understanding and providing written informed consent to participate and willing to comply with study procedures including providing a blood sample to be saved for potential pharmacokinetic and/or genetic analysis.
- The candidate, for any reason, requires surgical extraction of two or more third molars of which at least one is partially or fully impacted in mandibular bone.
- The candidate is postmenopausal, surgically sterile or agrees to use an effective and medically acceptable method of contraception for 1 week after his or her last dose of study drug.
- If female with child-bearing potential, the candidate must have a negative pregnancy test at screening and pre-surgery on the day of surgery.
Who cannot join
- The candidate typically or on average consumes more than one alcoholic beverage per day.
- The candidate is pregnant or nursing.
- The candidate has received an investigational drug or used an experimental medical device within 30 days prior to screening.
- The candidate has donated 1 or more pints of blood within 8 weeks prior to screening.
- The candidate has any hypersensitivity to components of the HT-6184/placebo formulations or the protocol-specified analgesic rescue medication, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs).
- The candidate has any contraindication to oral surgery or any serious or major medical problems that, in the investigator's opinion, may compromise the safety or the candidate or interfere with the interpretation of study results
- The candidate has taken acetaminophen, NSAIDs (including aspirin) or other medications for pain within 72 hours of the surgical procedure.
- The candidate has any abnormal laboratory value or physical finding that, in the opinion of the investigator, may compromise the individual's safety, interfere with interpretation of the study results, or be indicative of an underlying disease state.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase-2 Study to Evaluate the Ability of HT-6184 to Attenuate Diagnostic Biomarkers of Post-procedure Acute Inflammation and Manage Pain Following Third Molar Extraction
The goal of this clinical trial is to test the ability of HT-6184 to decrease inflammation and pain in patients after third molar removal.
The main question it aims to answer are:
- Does HT-6184 decrease inflammation in patients after third molar removal?
- Does HT-6184 decrease pain in patients after third molar removal?
Participants will be asked to do the following during the clinical trial:
- Take a single oral dose of HT-6184 or placebo
- Allow a oral surgeon remove their third molar teeth
- Blood draws on 5 occurrences
- Rate their pain intensity
- Attend two follow-up appointments on day 1 and day 2 after third molar removal
- Participate in one follow-up phone call 5-7 days after third molar removal
- Conditions
- Pain
- Being tested
- HT-6184, HT-6184 Placebo
- Keywords
- third molar extraction, inflammation, biomarkers
- Medical subject headings
- Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HT-6184Drug
Single, oral dose of HT-6184
HT-6184 PlaceboDrug
Single, oral dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| HT-6184 Treatment Arm | Active comparator | Not described Receives: Drug: HT-6184 |
| HT-6184 Placebo | Placebo comparator | Not described Receives: Drug: HT-6184 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum C-reactive protein levels from pre-dose
Measured: Up to 54 hours post surgery
Incidence of adverse events
Severity of AEs will be judged according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Up to 7 days post surgery
Incidence of serious adverse events
Severity of AEs will be judged according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Up to 7 days post surgery
Secondary outcomes (1)
Area under the categorical pain intensity-by-time curve (AUCs)
Measured: Up to 8 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start12 Feb 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halia Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Halia Study Director, Study director, Halia Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241742
- Sponsor's protocol ID
- HT-6184-PIR-001
- Status last verified
- Mar 2025
- First submitted
- 15 Jan 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-2 Study to Evaluate the Ability of HT-6184 to Attenuate Diagnostic Biomarkers of Post-procedure Acute Inflammation and Manage Pain Following Third Molar Extraction
- ClinicalTrials.gov ID
- NCT06241742
- Acronym / sponsor ID
- HT-6184-PIR-001
- Conditions
- Pain
- Keywords
- third molar extraction, inflammation, biomarkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Halia Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 5 Feb 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 goal of this clinical trial is to test the ability of HT-6184 to decrease inflammation and pain in patients after third molar removal.
The main question it aims to answer are:
- Does HT-6184 decrease inflammation in patients after third molar removal?
- Does HT-6184 decrease pain in patients after third molar removal?
Participants will be asked to do the following during the clinical trial:
- Take a single oral dose of HT-6184 or placebo
- Allow a oral surgeon remove their third molar teeth
- Blood draws on 5 occurrences
- Rate their pain intensity
- Attend two follow-up appointments on day 1 and day 2 after third molar removal
- Participate in one follow-up phone call 5-7 days after third molar removal
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HT-6184 Treatment Arm | Active comparator | Drug: HT-6184 |
| HT-6184 Placebo | Placebo comparator | Drug: HT-6184 Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The candidate is 18 years of age or older, capable of understanding and providing written informed consent to participate and willing to comply with study procedures including providing a blood sample to be saved for potential pharmacokinetic and/or genetic analysis.
- The candidate, for any reason, requires surgical extraction of two or more third molars of which at least one is partially or fully impacted in mandibular bone.
- The candidate is postmenopausal, surgically sterile or agrees to use an effective and medically acceptable method of contraception for 1 week after his or her last dose of study drug.
- If female with child-bearing potential, the candidate must have a negative pregnancy test at screening and pre-surgery on the day of surgery.
Key exclusion criteria (8 listed)
- The candidate typically or on average consumes more than one alcoholic beverage per day.
- The candidate is pregnant or nursing.
- The candidate has received an investigational drug or used an experimental medical device within 30 days prior to screening.
- The candidate has donated 1 or more pints of blood within 8 weeks prior to screening.
- The candidate has any hypersensitivity to components of the HT-6184/placebo formulations or the protocol-specified analgesic rescue medication, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs).
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-6184Single, oral dose of HT-6184 | Drug | HT-6184 Treatment Arm |
| HT-6184 PlaceboSingle, oral dose of placebo | Drug | HT-6184 Placebo |
Primary outcome
Change in serum C-reactive protein levels from pre-dose
Time frame: Up to 54 hours post surgery
Incidence of adverse events
Time frame: Up to 7 days post surgery
Severity of AEs will be judged according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Incidence of serious adverse events
Time frame: Up to 7 days post surgery
Severity of AEs will be judged according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
1 secondary outcome
Area under the categorical pain intensity-by-time curve (AUCs)
Time frame: Up to 8 hours after surgery
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 30 Mar 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.
Halia Study Director study director
Halia Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HT-6184 in people with Pain, 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 4 inclusion and 8 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 30 Mar 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in serum C-reactive protein levels from pre-dose (time frame: Up to 54 hours post surgery). The study lists 3 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 30 Mar 2025.