Escalating single and multiple oral doses of LTG-321 in healthy adults

A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study of LTG-321 Administered Orally to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male and Female Participants 18 to 55 Years of Age

This will test whether single and repeated oral doses of a new drug called LTG-321 are safe and how the drug behaves in healthy men and women aged 18 to 55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 236 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Latigo Biotherapeutics (Industry-sponsored)
• Locations: 1 site (Christchurch)
• Trial ID: NCT07110610 on ClinicalTrials.gov

What this trial studies

This first-in-human, randomized, double-blind, placebo-controlled Phase 1 study uses single ascending dose (SAD) and multiple ascending dose (MAD) cohorts to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral LTG-321 in healthy adults. A within-participant, double-blind, placebo-controlled crossover evaluates pain tolerance with a cold pressor test in healthy male participants, and an open-label crossover Food Effect cohort compares PK after a high-fat meal versus fasting. Participants will be screened for overall health (including BMI 18–30 kg/m2) and will attend multiple dosing and sampling visits at a single site in Christchurch, New Zealand. Results will inform dose selection and safety monitoring for subsequent patient trials.

Who should consider this trial

Good fit: Healthy men and women aged 18–55 with BMI 18–30 kg/m2, no significant medical conditions, and able to take oral medications are the intended participants, with healthy males included in the cold pressor pain testing subgroup.

Not a fit: People with significant cardiovascular, hepatic, renal, neurological, psychiatric, or other active systemic diseases, those outside the age or BMI limits, pregnant or breastfeeding individuals, or anyone unable to take oral medications are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the study will identify safe dose ranges and how LTG-321 is processed in the body, enabling later patient trials that could lead to new treatment options.

How similar studies have performed: This is the first human study of LTG-321, although SAD/MAD dose-escalation designs, cold pressor pain testing, and food-effect PK evaluations are well-established and commonly used successfully in early drug development.

Eligibility 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 18-30 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
* Participant is under legal custodianship.

Where this trial is running

Christchurch

• New Zealand Clinical Research — Christchurch, New Zealand (Recruiting)

Study contacts

• Study coordinator: Neil Singla, MD

Conditions Healthy Participants