Clinical trial NCT06241742: Evaluating Ability of HT-6184 to Reduce Inflammation and Pain After Third Molar Extraction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: third molar extraction
inflammation
biomarkers
Lead sponsor: Halia Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-05
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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?

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in serum C-reactive protein levels from pre-dose
timeFrame: Up to 54 hours post surgery
measure: Incidence of adverse events
timeFrame: Up to 7 days post surgery
measure: Incidence of serious adverse events
timeFrame: Up to 7 days post surgery
Secondary outcomes:
measure: Area under the categorical pain intensity-by-time curve (AUCs)
timeFrame: Up to 8 hours after surgery
Other outcomes:
Locations:
city: Murray
country: United States
facility: CenExel JBR
state: Utah
Study officials:
affiliation: Halia Therapeutics
name: Halia Study Director
role: STUDY_DIRECTOR
References: