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

NCT ID: NCT07110610

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-03
• Study Completion Date: 2026-07-31

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. In addition, a randomized, open-label, crossover Food Effect cohort will evaluate the impact of a high-fat meal on the pharmacokinetics of LTG-321 following single oral doses in the fed and fasted state.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LTG-321

receives active investigational drug

Group Type: EXPERIMENTAL

LTG-321

Intervention Type: DRUG

active investigational drug

Placebo

receives placebo comparator

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo-to-match LTG-321

Interventions

LTG-321

active investigational drug

Intervention Type: DRUG

Placebo

Placebo-to-match LTG-321

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Latigo Biotherapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

New Zealand Clinical Research

Christchurch, , New Zealand

Site Status: RECRUITING

Countries

New Zealand

Central Contacts

Neil Singla, MD

Role: CONTACT

nsingla@latigobio.com

626-862-7778

Facility Contacts

Cory Sellwood, MD

Role: primary

cory.sellwood@nzcr.co.nz

+64 3 372 9477

Other Identifiers

LTG-321-013

Identifier Type: -

Identifier Source: org_study_id