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

Latigo Biotherapeutics

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: LTG-001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06049095

LTG-001-001

Details and patient eligibility

About

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 administered LTG-001 in healthy male and female participants

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

LTG-001

Experimental group

Description:

Part A: Single-Ascending dose cohorts; relative bioavailability; food effect; Part B: Multiple-ascending dose cohorts

Treatment:

Drug: LTG-001

Placebo

Placebo Comparator group

Description:

Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts

Treatment:

Drug: Placebo