Evaluating Ability of HT-6184 to Reduce Inflammation and Pain After Third Molar Extraction

NCT ID: NCT06241742

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2024-04-30

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

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HT-6184 Treatment Arm

Group Type: ACTIVE_COMPARATOR

HT-6184

Intervention Type: DRUG

Single, oral dose of HT-6184

HT-6184 Placebo

Group Type: PLACEBO_COMPARATOR

HT-6184 Placebo

Intervention Type: DRUG

Single, oral dose of placebo

Interventions

HT-6184

Single, oral dose of HT-6184

Intervention Type: DRUG

HT-6184 Placebo

Single, oral dose of placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Halia Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Halia Study Director

Role: STUDY_DIRECTOR

Halia Therapeutics

Locations

CenExel JBR

Murray, Utah, United States

Countries

United States

Other Identifiers

HT-6184-PIR-001

Identifier Type: -

Identifier Source: org_study_id