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Recruiting Phase 1 NCT06049095

A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants

Phase 1 – testing safety in a small group of people
Conditions: Healthy

Sponsor: Latigo Biotherapeutics

trial.available_in: БГ
Overview
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 orally or intravenously administered LTG-001 in healthy male and female participants
Who can participate
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.
Locations 1
New Zealand (1)
Clinical Research Unit
Christchurch
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
No
Start date
17.10.2023
Completion date
28.04.2026
Registry ID
NCT06049095
Source
anzctr
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