Status:
ACTIVE_NOT_RECRUITING
A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 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) of orall...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06049095
Start Date
October 17 2023
End Date
February 28 2026
Last Update
September 29 2025
Active Locations (1)
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1
Clinical Research Unit
Christchurch, New Zealand