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

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: LTG-001; Drug: Placebo

• Registration Number: NCT06049095
• Lead Sponsor: Latigo Biotherapeutics

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 orally administered LTG-001 in healthy male and female participants

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-15
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-21
• Study Start: 2023-10-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-07-28
• Study Completion: 2025-09-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LTG-001	LTG-001	Part A: Single-Ascending dose cohorts; relative bioavailability; food effect; Part B: Multiple-ascending dose cohorts
Placebo	Placebo	Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts

Primary Outcome Measures

Name	Time	Method
Evaluate the safety and tolerability of single and multiple ascending oral doses, relative bioavailability and food effect of LTG-001 in healthy subjects	Up to 10 days of dosing	Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Name	Time	Method
To further characterize the PK of LTG-001 in healthy participants	Up to 10 days of dosing	Oral apparent volume of distribution (Vz/F)

Trial Locations

Locations (1)

Clinical Research Unit; 🇳🇿 Christchurch, New Zealand