Testing the safety and effects of LTG-001 in healthy volunteers
A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally of Intravenously to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Male and Female Participants 18 to 55 Years of Age
This study is testing a new oral medication called LTG-001 in healthy volunteers to see if it's safe and how the body processes it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Latigo Biotherapeutics Industry-sponsored |
| Locations | 1 site (Christchurch) |
| Trial ID | NCT06049095 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1 clinical trial designed to evaluate the safety, tolerability, and pharmacokinetics of LTG-001, an oral medication, in healthy participants. The study involves both single and multiple ascending doses administered in a randomized, double-blind, placebo-controlled manner. Participants will be closely monitored for any adverse effects and how the drug is processed in the body. The trial aims to gather essential data that will inform future studies on LTG-001.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male and female adults aged 18 to 55 with a BMI between 18-32.
Not a fit: Patients with significant health issues or those unable to take oral medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of a new treatment option that is safe and effective for future patient populations.
How similar studies have performed: While this study is focused on a specific new drug, similar Phase 1 studies have historically shown success in establishing safety and pharmacokinetics for new treatments.
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. * 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: * Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption * 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 * Has known psychiatric disorders that would interfere with the cooperation with the requirements of the study * Participant is under legal custodianship.
Where this trial is running
Christchurch
- Clinical Research Unit — Christchurch, New Zealand (Recruiting)
Study contacts
- Study coordinator: Desmond Padhi
- Email: LTG-001-001@latigobio.com
- Phone: 8057162936
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.