Phase 1 Single and Multiple Ascending Dose of LTG-321 in Healthy Participants

Not Applicable

Recruiting

• Conditions: Healthy Participants
• Interventions: Drug: LTG-321; Other: Placebo

• Registration Number: NCT07110610
• Lead Sponsor: Latigo Biotherapeutics

Brief Summary

This is a first-in-human, randomized, double-blind, placebo-controlled Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered LTG-321 in healthy male and female participants 18 to 55 years of age. The study will be conducted in New Zealand.

The study also includes a randomized, double-blind, placebo-controlled, within-participant crossover evaluation of pain tolerance using a cold pressor test in healthy male participants 18 to 55 years of age.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-30
• Study First Posted: 2025-08-07
• Status Verified: 2025-09
• Study Start: 2025-09-03
• Last Update Submitted: 2025-09-15
• Last Update Posted: 2025-09-19
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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 18-30 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
• Participant is under legal custodianship.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LTG-321	LTG-321	receives active investigational drug
Placebo	Placebo	receives placebo comparator

Primary Outcome Measures

Name	Time	Method
To evaluate the Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs) of single and multiple ascending oral doses of LTG-321 in healthy participants	Up to 14 days of dosing	Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)
To evaluate the Pain Detection and Tolerance Threshold during Cold Pressor Test of LTG-321 in healthy male participants.	Up to 5 days of dosing	Change from baseline at various individual time points and at various intervals for time to reach pain detection threshold (PDT) and time to reach pain tolerance threshold (PTT), for each dose of LTG-321 vs. placebo.

Trial Locations

Locations (1)

New Zealand Clinical Research; 🇳🇿 Christchurch, New Zealand