LTG-001 for Acute Pain

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Latigo Biotherapeutics

Must not be taking: NSAIDs, Benzodiazepines, Opioids, others

Disqualifiers: Hepatic function, Heart disease, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to learn if LTG-001 works to treat pain after third molar removal surgery in adults. It will also learn about the safety of LTG-001. The main questions it aims to answer are: Does drug LTG-001 treat the acute pain after surgical removal of impacted third molars (wisdom teeth) over 12 hours? How tolerable is LTG-001 after surgical removal of impacted third molars (wisdom teeth) over 12 hours? Researchers will compare drug LTG-001 to a placebo (a look-alike substance that contains no drug) to see if drug LTG-001 treats the post-surgical pain. Participants will: Take LTG-001 one time after the surgical removal of impacted third molars. Remain at the clinic for 12 hours after study dosing and return after a week for a safety check up. Report the pain relief during the 12 hours after dosing to record changes in the post-operative pain

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but it excludes those who use NSAIDs, benzodiazepines, opioids, or medications that affect heart rhythms. It's best to discuss your specific medications with the trial team.

Eligibility Criteria

Adults who've had their impacted third molars (wisdom teeth) surgically removed and are experiencing acute pain can participate. Specific details about eligibility criteria are not provided, but typically participants must be in good health aside from the condition being studied.

Inclusion Criteria

I am between 18 and 50 years old.

My post-surgery pain fits the study's criteria.

Subject must agree to study required use of birth control

+2 more

Exclusion Criteria

I cannot take medications by mouth.

I have sleep apnea or use a CPAP machine at home.

I haven't had dental or other surgeries in the last 60 days.

+6 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants take LTG-001 one time after the surgical removal of impacted third molars and remain at the clinic for 12 hours for monitoring

12 hours

1 visit (in-person)

Follow-up

Participants return after a week for a safety check-up

1 week

1 visit (in-person)

Participant Groups

The trial is testing LTG-001's effectiveness in treating post-surgical pain after wisdom tooth removal. It involves a single dose of LTG-001 at various strengths or a placebo, with patients monitored for 12 hours post-dosing and returning after a week for safety evaluation.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: LTG-001 Mid DoseExperimental Treatment2 Interventions

Group II: LTG-001 Low DoseExperimental Treatment2 Interventions

Group III: LTG-001 High DoseExperimental Treatment2 Interventions

Group IV: PlaceboPlacebo Group1 Intervention