Status:
COMPLETED
A Phase 1 Single and Multiple Ascending Dose Study of LTG-305 Administered Orally in Healthy Participants
Lead Sponsor:
Latigo Biotherapeutics
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a sequential, randomized, double-blind, placebo-controlled Phase 1 single (SAD) and multiple (MAD) ascending dose study to evaluate the safety, tolerability, and pharmacokinetics (PK) and Phar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2025
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06554574
Start Date
September 3 2024
End Date
June 16 2025
Last Update
July 4 2025
Active Locations (1)
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1
Clinical Research Unit
Christchurch, New Zealand