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Completed

NCT Number: NCT07110610

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Zealand Clinical Research

Christchurch, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LTG-321

Drug

active investigational drug

Placebo

Other

Placebo-to-match LTG-321

Primary outcomes

  1. 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

    Time frame: Up to 14 days of dosing

    Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)

  2. To evaluate the Pain Detection and Tolerance Threshold during Cold Pressor Test of LTG-321 in healthy male participants.

    Time frame: 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.

  3. Effect of Food on Pharmacokinetics of LTG-321

    Time frame: Up to approximately 48 hours post-dose in each treatment period

    Assessment of the effect of a high-fat meal on systemic exposure of LTG-321 following a single oral dose administered under fed and fasted conditions.

Sponsors and collaborators

Lead sponsor

Latigo Biotherapeutics

Industry

Registry information

Official study title

A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study of LTG-321 Administered Orally to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male and Female Participants 18 to 55 Years of Age

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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