Testing LTG-305 in healthy participants
A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study of LTG-305 Administered Orally to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male and Female Participants 18 to 55 Years of Age
This study is testing a new drug called LTG-305 in healthy men aged 18-55 to see how it affects pain tolerance and overall health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Latigo Biotherapeutics Industry-sponsored |
| Locations | 1 site (Christchurch) |
| Trial ID | NCT06554574 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and pharmacokinetics of LTG-305, administered orally to healthy participants. It involves a sequential, randomized, double-blind, placebo-controlled design with both single and multiple ascending doses. Additionally, a crossover evaluation of pain tolerance using a cold pressor test will be conducted specifically in healthy male participants aged 18-55. The study aims to gather data on how the drug affects pain perception and overall health.
Who should consider this trial
Good fit: Ideal candidates are healthy male and female participants aged 18 to 55 with a BMI between 18-32 kg/m2.
Not a fit: Patients with significant underlying health conditions or a history of substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and efficacy of LTG-305, potentially leading to new treatments for pain management.
How similar studies have performed: While this approach is common in early-phase drug testing, the specific drug LTG-305 has not been previously tested in this manner.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female participants aged 18 to 55 years, inclusive, at the time of signing the informed consent for SAD and MAD only. For Cold Pressor male participants 18 to 55 years. * Overtly healthy with no clinically relevant abnormalities based on the medical history, physical examinations, clinical laboratory evaluations, and 12-lead ECG that, in the opinion of the investigator, would affect participant safety. * Body mass index (BMI) within the range of 18-32 kg/m2 (inclusive). Exclusion Criteria: * Clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the investigator, unacceptably increase the participant's risk by participating in the study * Past or current history or evidence of alcohol abuse and/or dependence on recreational drug use * Donation of over 500 mL blood ≤ 3 months prior to start of participation * Participant is under legal custodianship.
Where this trial is running
Christchurch
- Clinical Research Unit — Christchurch, New Zealand (Recruiting)
Study contacts
- Study coordinator: Diamond Martin
- Email: dmartin@latigobio.com
- Phone: 818-309-3483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.