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

A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally of Intravenously to Evaluate the Safety, Tolerability, and Pharmacokinetics 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) of orally or intravenously administered LTG-001 in healthy male and female participants

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: LTG-001; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Desmond Padhi; Phone Number: 8057162936; Email: LTG-001-001@latigobio.com

Study Locations

• New Zealand
  • Christchurch, New Zealand
    • Recruiting
    • Clinical Research Unit
    • Contact: Chris Wynne, MD; Phone Number: + 64 3 372 9477; Email: Chris.Wynne@nzcr.co.nz

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.
• 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LTG-001; Part A: Single-Ascending dose cohorts; relative bioavailability; food effect; Part B: Multiple-ascending dose cohorts	Drug: LTG-001; Oral doses
Placebo Comparator: Placebo; Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts	Drug: Placebo; Oral doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the safety and tolerability of single and multiple ascending oral doses, relative bioavailability and food effect of LTG-001 in healthy subjects	Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)	Up to 10 days of dosing
Absolute Bioavailability of LTG-001 Following Oral and Intravenous Administration	Absolute bioavailability of LTG-001 will be assessed by comparing systemic exposure following a single oral tablet dose and a single intravenous dose.	from admission to completion in the study (35 days)
Safety and Tolerability of Intravenous LTG-001	Safety and tolerability of intravenous LTG-001 will be assessed by the number of participants with treatment-emergent adverse events (TEAEs), changes in clinical laboratory parameters, vital signs, electrocardiograms (ECGs), physical examination findings, and infusion site reactions following intravenous administration.	From first intravenous dose through end of study (up to 14 days following intravenous dosing)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To further characterize the PK of LTG-001 in healthy participants	Cmax	Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants	Area under the concentration curve from 0 to last (AUC0-last)	Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants	Area under the concentration curve from 0 to infinity (AUC0-inf)	Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants	Time of the maximum observed plasma concentration (tmax)	Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants	Elimination rate constant (λz)	Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants	Terminal elimination half-life (t1⁄2)	Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants	Concentration at 12 hours (C12)	Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants	Oral clearance (CL/F)	Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants	Oral apparent volume of distribution (Vz/F)	Up to 10 days of dosing

Collaborators and Investigators

• Sponsor: Latigo Biotherapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): April 28, 2026
• Study Completion (Estimated): April 28, 2026

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: LTG-001-001

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