Actively Recruiting
Phase 1 Single and Multiple Ascending Dose of LTG-321 in Healthy Participants
Led by Latigo Biotherapeutics · Updated on 2026-01-23
236
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human, randomized, double-blind, placebo-controlled Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered LTG-321 in healthy male and female participants 18 to 55 years of age. The study will be conducted in New Zealand. The study also includes a randomized, double-blind, placebo-controlled, within-participant crossover evaluation of pain tolerance using a cold pressor test in healthy male participants 18 to 55 years of age. In addition, a randomized, open-label, crossover Food Effect cohort will evaluate the impact of a high-fat meal on the pharmacokinetics of LTG-321 following single oral doses in the fed and fasted state.
CONDITIONS
Official Title
Phase 1 Single and Multiple Ascending Dose of LTG-321 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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).
You will not qualify if you...
- 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 64 3 months prior to start of participation
- Participant is under legal custodianship.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
New Zealand Clinical Research
Christchurch, New Zealand
Actively Recruiting
Research Team
N
Neil Singla, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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