A Phase 1 Single and Multiple Ascending Dose Study of LTG-305 Administered Orally in Healthy Participants

A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study of LTG-305 Administered Orally to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male and Female Participants 18 to 55 Years of Age

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) and Pharmacodynamics of orally administered LTG-305 in healthy male and female participants. The study will also include a randomized, double-blind, placebo-controlled within-participant crossover evaluation of pain tolerance during a cold pressor test in healthy male participants 18-55 years of age.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LTG-305

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand
    • Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and female participants aged 18 to 55 years, inclusive, at the time of signing the informed consent for SAD and MAD only. For Cold Pressor male participants 18 to 55 years.
• 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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: LTG-305; Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts
Experimental: LTG-305	Drug: LTG-305; Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and tolerability of single and multiple ascending oral doses of LTG-305 in healthy participants.	Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)	Up to 7 or 10 days of dosing
To evaluate the pharmacodynamics of LTG-305 in healthy male participants.	Change from baseline at various individual time points and at various intervals for time to reach PDT and time to reach PTT, for each dose of LTG-305 vs. placebo. Time to reach PDT and time to reach PTT at various individual time points and at various intervals for each dose of LTG-305 vs. placebo. Area above the Curve (AAC) calculated via NPRS scores vs. time, for each dose of LTG-305 vs. placebo Exposure response	0-24 hrs, 1-12 hours

Collaborators and Investigators

• Sponsor: Latigo Biotherapeutics

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): June 16, 2025

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: LTG-305-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No