RecruitingPhase 1NCT06049095

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

A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally of Intravenously to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Male and Female Participants 18 to 55 Years of Age

Sponsor

Latigo Biotherapeutics

Enrollment

204 participants

Start Date

Oct 17, 2023

Study Type

INTERVENTIONAL

Conditions

Healthy

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 orally or intravenously administered LTG-001 in healthy male and female participants

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria3

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 Criteria6

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.